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Personalized Nutrition Advice for Optimizing Dietary Habits and Metabolic Status (PREVENTOMICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04641559
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Collaborators:
Fundació Eurecat
Hospital Universitari Sant Joan de Reus
Universitat Rovira i Virgili
Horizon 2020 - European Commission
Information provided by (Responsible Party):
Technological Centre of Nutrition and Health, Spain

Brief Summary:

The alteration maintained over time of some metabolic processes, such as oxidative stress, low-grade inflammation, carbohydrate and lipid metabolism, and of the intestinal microbiota activity, can induce some chronic diseases with high prevalence in society, such as obesity, cardiovascular disease or diabetes. These metabolic alterations can be modulated through nutrition and eating habits. Thus nutritional interventions are currently considered as a main tool for disease prevention.

The need to adapt nutritional interventions to the particular needs of each person in order to improve the health status of all individuals is becoming more and more evident, through precision nutrition. On the other hand, for nutritional interventions to be carried out over long periods of time and to achieve sustainable long-term changes in lifestyle, new forms of behavioral counseling are necessary to facilitate the follow-up of nutritional interventions.

PREVENTOMICS is a European project that arose to develop a personalized nutrition system, the PREVENTOMICS system. This system is based on the classification of the users of the system according to the state of their own metabolic processes, their genotype, their dietary habits and preferences, levels of physical activity, purchase preference and possible allergies, in order to provide a personalized nutrition adapted to the needs of each user.

The PREVENTOMICS system is presented through a digital environment via computer, with a list of products provided by the ALDI supermarket to prepare the shopping list, without having to buy the products from the ALDI supermarket.


Condition or disease Intervention/treatment Phase
Personalized Nutrition Health Status Dietary Habits Other: Personalized nutrition group Other: Personalized Plan group Other: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Personalized Nutrition Advice Based on Metabolic Profiling and Behaviour Assessment for Optimizing Dietary Habits and Metabolic Status. Single Blind, Parallel, Randomized, Controled Intervention Trial (EUT_PREVENTOMICS)
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: Personalized nutrition group
Intervention group that will receive personalized nutrition advice through the ALDI's catalogue during four months.
Other: Personalized nutrition group

A digital environment which combines biological information, personal habits and preference to provide nutritional recommendations. This digital environment is composed by the follow softwares:1. The recommender system: software that combine the behavioral and biological information about the volunteer and generates personalized nutritional recommendations; 2. The ALDI microsite: A microsite that retrieves the personalized recommendations for the volunteer from the recommender system. The ALDI microsite matches food categories with products of the ALDI catalogue. As a result, the volunteer receives a list of products classified under different food categories that are recommended for him/her. Next to each food category, the number of servings recommended (weekly or daily) is also shown.

The ALDI microsite is a tool only to elaborate a shopping list through personalized recommendations. Therefore, volunteers can choose to buy their food shopping list at wherever store other from ALDI.


Experimental: Personalized Plan group
Intervention group that will receive personalized nutrition advice through the ALDI's catalogue and behavioural change program during four months.
Other: Personalized Plan group
Participants will use the same software described in for the Personalized nutrition group together with a behavioral change program designed to increase the adherence to the recommendations provided by the ALDI microsite by promoting a proper attitude by means of a series of personalized, goal-orientated, friendly, achievable actions delivered periodically to the volunteer. The behavioral change program will be fed with the results of behavior questionnaires. The personalized messages will be delivered through the ALDI microsite. These personalized messages will be available only for those subjects engaged in the Personalized Plan group.

Placebo Comparator: Control group
General recommendations but not personalization nor behavioural change advice will be implemented during four months.
Other: Control group
The participants in the control group will not have personalized recommendations. These participants will have access to a restricted version of the ALDI microsite where the list of recommended products correspond to categories that are general recommendations according to Mediterranean diet.




Primary Outcome Measures :
  1. Change in Adherence to Mediterranean diet. [ Time Frame: At weeks 2 and 25. ]
    Adherence to Mediterranean diet measured through the MEditerranean Diet Adherence Screener (MEDAS). The questionnaire consists of 14 questions about eating habits, the frequency of consumption of typical foods of the Mediterranean diet or the consumption of foods not recommended in this diet. Each question is screened with 0 (non-compliant) or 1 (compliant) and the total score range from 0 to 14, so a score of 14 points mean maximum adherence.


Secondary Outcome Measures :
  1. Change in body weight. [ Time Frame: At weeks 2 and 25 ]
    Body weight measured by TANITA SC330.

  2. Height. [ Time Frame: At weeks 2 ]
    Height measured by standardized methods.

  3. Change in BMI [ Time Frame: At weeks 2 and 25 ]
    Weight and Height will be combined to report BMI in kg/m^2.

  4. Change in waist circumference. [ Time Frame: At weeks 2 and 25 ]
    Waist circumference using a measuring tape.

  5. Change in blood pressure (in mmHg). [ Time Frame: At weeks 2 and 25 ]
    Systolic and systolic blood pressure will be measured twice after 2-5 minutes of patient respite, seated, with one-minute interval in between, using an automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain).

  6. Change in urinalysis. [ Time Frame: At weeks 2 and 25 ]
    Urine urinalysis will be measured by standardized methods in Cobas Mira Plus autoanalyzer .(Roche Diagnostics Systems, Madrid, Spain).

  7. Change in blood cell count. [ Time Frame: At weeks 2 and 25 ]
    Blood cell count will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

  8. Change in serum creatinine levels. [ Time Frame: At weeks 2 and 25 ]
    Serum creatinine levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

  9. Change in serum urea levels. [ Time Frame: At weeks 2 and 25 ]
    Serum urea levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

  10. Change in serum uric acid levels. [ Time Frame: At weeks 2 and 25 ]
    Serum uric acid levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

  11. Change in serum bilirubin levels. [ Time Frame: At weeks 2 and 25 ]
    Serum bilirubin levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

  12. Change in serum ions levels. [ Time Frame: At weeks 2 and 25 ]
    Serum ions levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

  13. Change in serum proteins levels. [ Time Frame: At weeks 2 and 25 ]
    Serum proteins levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

  14. Change in serum aspartate aminotransferase levels. [ Time Frame: At weeks 2 and 25 ]
    Serum aspartate aminotransferase levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

  15. Change in serum alanine aminotransferase levels. [ Time Frame: At weeks 2 and 25 ]
    Serum alanine aminotransferase levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).

  16. Change in plasma IL-6 levels. [ Time Frame: At weeks 2 and 25 ]
    Plasma IL-6 levels will be measured by human ELISA kits.

  17. Change in plasma TNFα levels. [ Time Frame: At weeks 2 and 25 ]
    Plasma TNFα levels will be measured by human ELISA kits.

  18. Change in plasma MCP-1 levels. [ Time Frame: At weeks 2 and 25 ]
    Plasma MCP-1 levels will be measured by human ELISA kits.

  19. Change in plasma IL-8 levels. [ Time Frame: At weeks 2 and 25 ]
    Plasma IL-8 levels will be measured by human ELISA kits.

  20. Change in plasma soluble ICAM1 levels. [ Time Frame: At weeks 2 and 25 ]
    Plasma soluble ICAM1 levels will be measured by human ELISA kits.

  21. Change in plasma soluble CD14 levels. [ Time Frame: At weeks 2 and 25 ]
    Plasma soluble CD14 levels will be measured by human ELISA kits.

  22. Change in urine N-acetylglycoproteins levels. [ Time Frame: At weeks 2 and 25 ]
    Urine N-acetylglycoproteins levels will be measured using proton nuclear magnetic resonance.

  23. Change in urine fucose levels. [ Time Frame: At weeks 2 and 25 ]
    Urine fucose levels will be measured using proton nuclear magnetic resonance.

  24. Change in serum total PUFAs levels. [ Time Frame: At weeks 2 and 25 ]
    Serum total PUFAs levels will be measured using proton nuclear magnetic resonance.

  25. Change in serum ARA and EPA levels. [ Time Frame: At weeks 2 and 25 ]
    Serum ARA and EPA levels will be measured using proton nuclear magnetic resonance.

  26. Change in serum DHA levels. [ Time Frame: At weeks 2 and 25 ]
    Serum DHA levels will be measured using proton nuclear magnetic resonance.

  27. Change in serum linoleic acid levels. [ Time Frame: At weeks 2 and 25 ]
    Serum linoleic acid levels will be measured using proton nuclear magnetic resonance.

  28. Change in plasma lysophosphatidylcholine levels. [ Time Frame: At weeks 2 and 25 ]
    Plasma lysophosphatidylcholine levels will be measured using proton nuclear magnetic resonance.

  29. Change in serum acetate levels. [ Time Frame: At weeks 2 and 25 ]
    Serum acetate levels will be measured using proton nuclear magnetic resonance.

  30. Change in urine acetate levels. [ Time Frame: At weeks 2 and 25 ]
    Urine acetate levels will be measured using proton nuclear magnetic resonance.

  31. Change in serum lactate levels. [ Time Frame: At weeks 2 and 25 ]
    Serum lactate levels will be measured using proton nuclear magnetic resonance.

  32. Change in urine lactate levels. [ Time Frame: At weeks 2 and 25 ]
    Urine lactate levels will be measured using proton nuclear magnetic resonance.

  33. Change in urine TMAO levels. [ Time Frame: At weeks 2 and 25 ]
    Urine TMAO levels will be measured using proton nuclear magnetic resonance.

  34. Change in urine TMA levels. [ Time Frame: At weeks 2 and 25 ]
    Urine TMA levels will be measured using proton nuclear magnetic resonance.

  35. Change in urine DMA levels. [ Time Frame: At weeks 2 and 25 ]
    Urine TMA levels will be measured using proton nuclear magnetic resonance.

  36. Change in plasma LPS levels. [ Time Frame: At weeks 2 and 25 ]
    Plasma LPS levels will be measured using gas chromatography mass spectrometry.

  37. Change in plasma glucose levels [ Time Frame: At weeks 2 and 25 ]
    Plasma glucose levels will be measured by enzymatic methods.

  38. Change in plasma insulin levels [ Time Frame: At weeks 2 and 25 ]
    Plasma insulin levels will be measured by human ELISA kits.

  39. Change in plasma leptin levels [ Time Frame: At weeks 2 and 25 ]
    Plasma leptin levels will be measured by human ELISA kits.

  40. Change in plasma adiponectin levels [ Time Frame: At weeks 2 and 25 ]
    Plasma adiponectin levels will be measured by human ELISA kits.

  41. Change in urine α-hydroxybutyrate levels [ Time Frame: At weeks 2 and 25 ]
    Urine α-hydroxybutyrate levels will be measured using proton nuclear magnetic resonance.

  42. Change in urine α-ketoglutarate levels [ Time Frame: At weeks 2 and 25 ]
    Urine α-ketoglutarate levels will be measured using proton nuclear magnetic resonance.

  43. Change in urine fumarate levels [ Time Frame: At weeks 2 and 25 ]
    Urine fumarate levels will be measured using proton nuclear magnetic resonance.

  44. Change in urine succinate levels [ Time Frame: At weeks 2 and 25 ]
    Urine succinate levels will be measured using proton nuclear magnetic resonance.

  45. Change in urine malate levels [ Time Frame: At weeks 2 and 25 ]
    Urine malate levels will be measured using proton nuclear magnetic resonance.

  46. Change in plasma acylcarnitine profile levels [ Time Frame: At weeks 2 and 25 ]
    Plasma acylcarnitine profile levels will be measured by liquid chromatography mass spectrometry.

  47. Change in HOMA-IR levels [ Time Frame: At weeks 2 and 25 ]
    HOMA-IR will be measured based on fasting blood levels of glucose an insulin.

  48. Change in leptin to adiponectin ratio [ Time Frame: At weeks 2 and 25 ]
    Leptin to adiponectin ratio will be calculated using blood levels of leptin ad adiponectin.

  49. Change in plasma total cholesterol levels [ Time Frame: At weeks 2 and 25 ]
    Plasma total cholesterol levels will be measured by enzymatic methods.

  50. Change in plasma HDL-cholesterol levels [ Time Frame: At weeks 2 and 25 ]
    Plasma HDL-cholesterol levels will be measured by enzymatic methods.

  51. Change in plasma non-HDL-cholesterol levels [ Time Frame: At weeks 2 and 25 ]
    Plasma non-HDL-cholesterol levels will be measured by enzymatic methods.

  52. Change in plasma triglycerides levels [ Time Frame: At weeks 2 and 25 ]
    Plasma triglycerides levels will be measured by enzymatic methods.

  53. Change in plasma LDL-cholesterol levels [ Time Frame: At weeks 2 and 25 ]
    Plasma LDL-cholesterol levels will be measured using the Friedwald formula.

  54. Change in the atherogenic index of plasma [ Time Frame: At weeks 2 and 25 ]
    The atherogenic index of plasma will be calculated as log(TG/HDL-cholesterol).

  55. Change in serum total MUFAs levels [ Time Frame: At weeks 2 and 25 ]
    Serum total MUFAs levels will be measured using proton nuclear magnetic resonance.

  56. Change in serum oleic acid levels [ Time Frame: At weeks 2 and 25 ]
    Serum oleic acid levels will be measured using proton nuclear magnetic resonance.

  57. Change in plasma total lysophosphatidylcholine levels [ Time Frame: At weeks 2 and 25 ]
    Plasma total lysophosphatidylcholine levels will be measured using proton nuclear magnetic resonance.

  58. Change in urine 8-hydroxy-2'-deoxyguanosine levels [ Time Frame: At weeks 2 and 25 ]
    Urine 8-hydroxy-2'-deoxyguanosine levels will be measured by human ELISA kits.

  59. Change in urine 8-iso-prostaglandin F2α levels [ Time Frame: At weeks 2 and 25 ]
    Urine 8-iso-prostaglandin F2α levels will be measured by human ELISA kits.

  60. Change in plasma 3-Nitrotyrosine levels [ Time Frame: At weeks 2 and 25 ]
    Plasma 3-Nitrotyrosine levels will be measured by human ELISA kits.

  61. Change in urine Pseudouridine levels [ Time Frame: At weeks 2 and 25 ]
    Urine Pseudouridine levels will be measured using proton nuclear magnetic resonance.

  62. Metabolomics for consumption biomarkers [ Time Frame: At weeks 2 and 25 ]
    The main biomarkers of food consumption will be measured using High Resolution Liquid chromatography- tandem Mass Spectrometry (HR-LC-MS/MS) in urine.

  63. Genotyping analysis [ Time Frame: At week 2 ]
    The main Single Nucleotide Polymorphisms (SNPs) related to nutrition associated disorders will be measured using oral smear and by Open Array Technology.

  64. Change in nutrition habits [ Time Frame: At weeks 2 and 25 ]
    Nutritional habits and daily intake will be measured using the servings per day, week or month of the different food groups that make up the Preventomics food frequency questionnaire, an adapted food questionnaire from The European Prospective Investigation into Cancer and Nutrition (EPIC) study.

  65. Change in physical activity [ Time Frame: At weeks 2 and 25 ]
    Physical activity will be evaluated through the International Physical Activity Questionnaire (IPAQ)-short for physical activity questionnaire. The questionnaire asks about three specific types of activity (walking, moderate-intensity activities and vigorous intensity activities) in the set domains leisure time, domestic and gardening (yard) activities, work-related and transport-related activities. Frequency and duration are collected separately for each specific type of activity. Both, categorical and continuous indicators will be measured.

  66. Change in satisfaction with weight-management diets. [ Time Frame: At weeks 2 and 25 ]
    Quality of life will be estimated through Diet Satisfaction questionnaire (DSat-28). The questionnaire consists of 28 questions with a five point level scale with higher scores indicating greater satisfaction.

  67. Change in person's perceptions in life related to mobility, self-care, usual activities, paint/discomfort and anxiety/depression. [ Time Frame: At weeks 2 and 25 ]
    Quality of life will be estimated through Euro Qol 5 Dimension (EQ-5D) questionnaire. The questionnaire consist of 28 questions with a five point scale with1 indicating the best health status and 5 indicating the worst health status, plus a visual analog score to report the perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

  68. Change in person's global perception in life related to being overweight and trying to lose weight. [ Time Frame: At weeks 2 and 25 ]
    Quality of life will be estimated through Obesity and Weight-Loss Quality of Life instrument (OWLQOL). The questionnaire consists of 17 statements with a six point scale, with 1 indicating the best quality of life and 6 indicating the worst quality of life.

  69. Change in hip circumference [ Time Frame: At weeks 2 and 25 ]
    Hip circumference will be measured using a measuring tape

  70. Change in body composition [ Time Frame: At weeks 2 and 25 ]
    Body fat mass and body lean mass (in € and in kg) will be measured using Tanita Body Composition Analyzer.

  71. Change in dietary intake [ Time Frame: At weeks 2 and 25 ]
    Dietary intake will be measured using 3-day dietary record.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women.
  • Signed informed consent.
  • To have internet access.

Exclusion Criteria:

  • Diabetes (or glucose ≥ 126 mg/dL or pharmacological treatment).
  • Hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg or pharmacological treatment).
  • Dyslipidaemia (cLDL ≥4.9 mmol/L and/or triglycerides ≥4.5 mmol/L (≥400 mg/dL) and/or cHDL <40 mg/dL (1.03 mmol/L) in men and <50 mg/dL (1.29 mmol/L) in women) or with pharmacological treatment.
  • Use of prescribed medicine to control acute or chronic inflammation.
  • Anaemia (haemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
  • BMI (in kg/m2) <18.5 or >35.
  • Being pregnant or planning to become pregnant within the study period.
  • Be in breastfeeding period.
  • Current smokers.
  • Participate in or have participate in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
  • Present some chronic gastrointestinal disease.
  • Present some chronic disease with clinical manifestation, like coronary heart diseases, cardiovascular disease, coeliac disease, Crohn's disease and chronic kidney disease (or serum creatinine ≥1.7 mg/dL for men and ≥1.5 mg/dL for women).
  • Following a prescribed diet for any reason, including weight loss, in the last 3 months.
  • Following a pharmacological treatment for weight loss or intake of food supplements or medications that could affect body weight.
  • Having allergies or food intolerances.
  • No or limited access to the Internet.
  • Consumption of more than 14 drinks of alcoholic beverages per week.
  • Mediterranean Diet Adherence Score (MEDAS) > 8 of 14 points, which is a food pattern already highly concordant with the Mediterranean Diet.
  • Being unable to follow the study guidelines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641559


Contacts
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Contact: Rosa M Valls, PhD 0034 636944723 estudis@ctns.cat
Contact: Anna Crescenti, PhD 0034 977 300 431 anna.crescenti@eurecat.org

Locations
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Spain
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
Reus, Tarragona, Spain, 43204
Contact: Rosa M Valls, PhD    0034 636 944 723    estudis@ctns.cat   
Contact: Anna Crescenti, PhD    0034 977 300 431    anna.crescenti@eurecat.org   
Sponsors and Collaborators
Technological Centre of Nutrition and Health, Spain
Fundació Eurecat
Hospital Universitari Sant Joan de Reus
Universitat Rovira i Virgili
Horizon 2020 - European Commission
Investigators
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Principal Investigator: Rosa Solà, Dr UTNS (Eurecat_Reus)/HUSJR. Reus, Tarragona. Spain.
Study Director: Josep M Del Bas, PhD UTNS (Eurecat_Reus)
Additional Information:
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Responsible Party: Technological Centre of Nutrition and Health, Spain
ClinicalTrials.gov Identifier: NCT04641559    
Other Study ID Numbers: EUT_PREVENTOMICS
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data sharing plans for the current study are unknown and will be made available at a later date

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Technological Centre of Nutrition and Health, Spain:
Metabolic status
gut microbiota
Behavioural intervention
Mediterranean diet
Retailer website
Preventomics
Digital environment