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Completed

NCT Number: NCT02003586

Effect of a Plant-based Ingredient on Generalized Hormonal Responses

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.

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Eurofins Optimed Clinical research

Gières, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

plant-based ingredient

Dietary Supplement

No plant-based ingredient

Dietary Supplement

Primary outcomes

  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 outcomes

  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 outcomes

  1. Blood glucose response (+iAUC)

    Time frame: 120 and 180 minutes

    Effect on blood glucose response.

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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