Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of a Plant-based Ingredient on Generalized Hormonal Responses

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003586
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : April 9, 2014
Sponsor:
Information provided by (Responsible Party):
Unilever R&D

Brief Summary:
The study is designed to determine the extent to which foods containing a plant-based ingredient affect blood glucose and hormonal response in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: plant-based ingredient Dietary Supplement: No plant-based ingredient Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Effect of a Plant-based Ingredient on Generalized Hormonal Responses
Study Start Date : December 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Plant-based ingredient to a starchy meal
Plant-based ingredient
Dietary Supplement: plant-based ingredient
Dietary Supplement: No plant-based ingredient
Starchy meal alone
No plant-based ingredient
Dietary Supplement: plant-based ingredient
Dietary Supplement: No plant-based ingredient



Primary Outcome Measures :
  1. AUC of post-prandial hormones [ Time Frame: 120 minutes ]
    Amylin (total) will be assessed.

  2. AUC of post-prandial hormones [ Time Frame: 120 minutes ]
    Ghrelin (active) will be assessed.

  3. AUC of post-prandial hormones [ Time Frame: 120 minutes ]
    Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.

  4. AUC of post-prandial hormones [ Time Frame: 120 minutes ]
    Glucagon-like peptide-1 (GLP-1) (active) will be assessed.

  5. AUC of post-prandial hormones [ Time Frame: 120 minutes ]
    Leptin will be assessed.

  6. AUC of post-prandial hormones [ Time Frame: 120 minutes ]
    Pancreatic polypeptide (PP) will be assessed.

  7. AUC of post-prandial hormones [ Time Frame: 120 minutes ]
    Peptide YY (PYY) (total) will be assessed.

  8. AUC of post-prandial hormones [ Time Frame: 120 minutes ]
    Insulin will be assessed.

  9. AUC of post-prandial hormones [ Time Frame: 120 minutes ]
    C-peptide will be assessed.

  10. AUC of post-prandial hormones [ Time Frame: 120 minutes ]
    Glucagon will be assessed.


Secondary Outcome Measures :
  1. AUC of post-prandial hormones [ Time Frame: 180 and 240 minutes ]
    Amylin (total) will be assessed.

  2. AUC of post-prandial hormones [ Time Frame: 180 and 240 minutes ]
    Ghrelin (active) will be assessed.

  3. AUC of post-prandial hormones [ Time Frame: 180 and 240 minutes ]
    Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.

  4. AUC of post-prandial hormones [ Time Frame: 180 and 240 minutes ]
    Pancreatic polypeptide (PP) will be assessed.

  5. AUC of post-prandial hormones [ Time Frame: 180 and 240 minutes ]
    Peptide YY (PYY) (total) will be assessed.

  6. AUC of post-prandial hormones [ Time Frame: 180 and 240 minutes ]
    Leptin will be assessed.

  7. AUC of post-prandial hormones [ Time Frame: 180 and 240 minutes ]
    Glucagon will be assessed.

  8. AUC of post-prandial hormones [ Time Frame: 180 and 240 minutes ]
    Insulin will be assessed.

  9. AUC of post-prandial hormones [ Time Frame: 180 and 240 minutes ]
    C-peptide will be assessed.

  10. AUC of post-prandial hormones [ Time Frame: 180 and 240 minutes ]
    Glucagon-like peptide-1 (GLP-1) (active) will be assessed.


Other Outcome Measures:
  1. Blood glucose response (+iAUC) [ Time Frame: 120 and 180 minutes ]
    Effect on blood glucose response.



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.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males, Age at start of the study >20 and <50 years;
  • Body mass index (BMI) ≥ 20,0 and ≤ 25,0 kg/m2;
  • Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases);
  • Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
  • Agreeing to be informed about medically relevant personal test-results by a physician;
  • Informed consent signed;
  • Willing to comply to study protocol during study;
  • Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.
  • Accessible veins on arms as determined by examination at screening.

Exclusion Criteria:

  • Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
  • Blood donation in the past 2 months;
  • Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
  • Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM;
  • Reported intense sporting activities > 10h/w;
  • Consumption of > 21 alcoholic drinks in a typical week;
  • Not being used to eat breakfast;
  • Reported use of any nicotine containing products in the six months preceding the study and during the study itself;
  • Use of medication which interferes with study measurements;
  • Reported dietary habits: medically prescribed diet, slimming diet;
  • Not used to eat 3 meals a day;
  • Vegetarian;
  • Reported weight loss/gain (>10%) in the last six month before the study;
  • Being an employee of Unilever and CRO;
  • Allergy or intolerance to food products and aversion to food products provided during the study;
  • Subject who cannot be contacted in case of emergency;
  • Subject who, in the judgment of the investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
  • Subject under guardianship;
  • Subject who would receive more than 4500 euro's as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.

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): NCT02003586


Locations
Layout table for location information
France
Eurofins Optimed Clinical research
Gieres, France
Sponsors and Collaborators
Unilever R&D
Investigators
Layout table for investigator information
Principal Investigator: Yves DONAZZOLO, M.D., M.Sc. EUROFINS OPTIMED, GIERES - France
Layout table for additonal information
Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT02003586    
Other Study ID Numbers: FDS-NAA-1462
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: January 2014
Keywords provided by Unilever R&D:
subjects