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Dairy Intervention in People With Obesity (DIPO)

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: NCT04154475
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:

Obesity is associated with increased morbidity and mortality, but weight reduction is difficult to achieve. In this randomized controlled trial we will include 120 obese subjects. Subjects will be allocated to one of the 3 diet types (minus 500 kcal / d):

  • Yoghurt diet: 500 g low-fat yogurt / d, about 1000-1100 mg calcium / d,
  • Milk product diet: 500 g of low-fat milk or buttermilk / d, about 1000-1100 mg calcium / d
  • Standard diet: 500 g soy yogurt / d, about 500 mg calcium / d Primary endpoint is the change in fat mass (baseline vs. 12 weeks), secondary endpoints are metabolic and endocrine parameters, gut microbiome, quality of life, hunger and satiety.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: yogurt diet Dietary Supplement: dairy diet Dietary Supplement: standard diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dairy Intervention in People With Obesity
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: yogurt diet
yogurt-diet (-500 kcal/day, 500 g yogurt, high calcium)
Dietary Supplement: yogurt diet
500 g yogurt/day

Active Comparator: dairy diet
dairy diet: -500 kcal/day, high calcium, 500 g non-yogurt dairy products
Dietary Supplement: dairy diet
500 g non-yogurt dairy products

Active Comparator: standard diet
standard diet: -500 kcal/day, low calcium, 500 g soya-yogurt
Dietary Supplement: standard diet
500 g soya-yogurt




Primary Outcome Measures :
  1. fat mass [ Time Frame: 12 weeks ]
    Changes in body fat mass assessed via dual-energy X-ray absorptiometry (DXA) (baseline vs. 12 weeks).


Secondary Outcome Measures :
  1. Body weight [ Time Frame: 12 weeks ]
    body weight [kg]

  2. BMI [ Time Frame: 12 weeks ]
    BMI [kg/m²]

  3. waist circumference [ Time Frame: 12 weeks ]
    waist circumference [cm]

  4. hip circumference [ Time Frame: 12 weeks ]
    hip circumference [cm]

  5. Systolic blood pressure [ Time Frame: 12 weeks ]
    systolic blood pressure [mm Hg]

  6. Diastolic blood pressure [ Time Frame: 12 weeks ]
    diastolic blood pressure [mm Hg]

  7. Body composition-lean mass [ Time Frame: 12 weeks ]
    lean mass [kg]

  8. Body composition-total body fat [ Time Frame: 12 weeks ]
    total body fat ([%]

  9. Body composition-gynoid fat mass [ Time Frame: 12 weeks ]
    gynoid fat mass [kg]

  10. Body composition-android fat mass [ Time Frame: 12 weeks ]
    android fat mass [kg]

  11. AUCglucose [ Time Frame: 12 weeks ]
    Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCglucose

  12. AUCinsulin [ Time Frame: 12 weeks ]
    Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCinsulin

  13. HOMA-IR [ Time Frame: 12 weeks ]
    Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)

  14. HOMA-beta [ Time Frame: 12 weeks ]
    insulin sensitivity assessed by HOMA-beta

  15. MATSUDA [ Time Frame: 12 weeks ]
    insulin sensitivity assessed by MATSUDA-index

  16. QUICKI [ Time Frame: 12 weeks ]
    insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI)

  17. Total cholesterol [ Time Frame: 12 weeks ]
    Total cholesterol [mg/dl]

  18. LDL cholesterol [ Time Frame: 12 weeks ]
    LDL cholesterol [mg/dl]

  19. HDL cholesterol [ Time Frame: 12 weeks ]
    HDL cholesterol [mg/dl]

  20. Triglycerides [ Time Frame: 12 weeks ]
    Triglycerides [mg/dl]

  21. HbA1c [ Time Frame: 12 weeks ]
    HbA1c [mmol/mol]

  22. Total testosterone [ Time Frame: 12 weeks ]
    Total testosterone [nmol/l]

  23. Free testosterone [ Time Frame: 12 weeks ]
    Free testosterone [nmol/l]

  24. Free androgen index [ Time Frame: 12 weeks ]
    FAI (Free androgen index)

  25. androstenedione [ Time Frame: 12 weeks ]
    androstenedione [nmol/l]

  26. DHEAS [ Time Frame: 12 weeks ]
    dehydroepiandrosterone sulfate (DHEAS) [µmol/L]

  27. stool microbiome [ Time Frame: 12 weeks ]
    Composition of the stool microbiome Microbiome analysis will be performed through the following steps: patient collection and provision of a stool specimen, DNA isolation from the specimen, PCR reaction to amplify the selected region of the 16S rRNA gene (only present in bacteria), sequencing of the amplicons using next-generation sequencing technology, bioinformatics processing and analysis of the data using suitable software.

  28. Satiety [ Time Frame: 12 weeks ]
    assessed via visual analogue scale [VAS]: "Satiety", minimum score 0, maximum score 10, higher scores mean a worse outcome.

  29. Food craving [ Time Frame: 12 weeks ]
    assessed via visual analogue scale [VAS]: "Food craving", minimum score 0, maximum score 10, higher scores mean a worse outcome.

  30. Quality of life during weight reduction [ Time Frame: 12 weeks ]
    Quality of life assessed via visual analogue scale [VAS]: "How is your quality of life during weight reduction?", minimum score 0, maximum score 10, higher scores mean a better outcome.

  31. Compliance [ Time Frame: 12 weeks ]
    assessed via visual analogue scale [VAS]: "Compliance", minimum score 0, maximum score 10, higher scores mean a better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥30 kg/m²
  • Age of ≥18 and <60 years
  • Written informed consent before study entry
  • Willingness to introduce a dietary change to lose weight

Exclusion Criteria:

  • Serum calcium ≥2.7 mmol/l
  • Dislike or intolerance of dairy products, reporting adverse responses or allergy to dairy products
  • Pregnancy or lactating women
  • Having given birth in the last year or planning a pregnancy in the next 6 months
  • Menopause (as defined by FSH levels ≥30 IU/l)
  • Disorders associated with androgen excess and/or menstrual irregularities except PCOS (overt thyroid dysfunction, hyperprolactinemia, adrenal hyperplasia, androgen secreting tumors)
  • Malabsorption syndrome
  • Intake of medication influencing metabolic or endocrine parameters (insulin sensitizers, oral contraceptives, …), obesity pharmacotherapeutic agents, or calcium supplements in the last 3 months before study entry
  • Regular intake of calcium supplements in the last 3 months before study entry
  • Lifestyle changes (changes in physical activity) or weight reduction (≥10% of body weight) in the last 3 months before study entry

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): NCT04154475


Contacts
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Contact: Elisabeth Lerchbaum, MD 0043 316 385 12383 elisabeth.lerchbaum@medunigraz.at

Locations
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Austria
Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Elisabeth Lerchbaum, MD Medical University of Graz
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT04154475    
Other Study ID Numbers: DIPO 1.0
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Medical University of Graz:
yogurt
dairy
calcium
weight reduction
obesity
randomized controlled trial
body composition
microbiome
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight