CompletedNCT02003586Updated Apr 9, 2014

Effect of a Plant-based Ingredient on Generalized Hormonal Responses

An interventional study of plant-based ingredient and No plant-based ingredient in Healthy, sponsored by Unilever R&D. Completed at 1 site in France. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-09.

Sponsored by Unilever R&D · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 20 Years to 50 Years
Sex: Male

Study 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.

Conditions studied

Healthy

Keywords

subjects

In context

Lead sponsor

Unilever R&D is the lead sponsor of 69 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 50 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Investigator)
Enrollment: 12 participants (actual)

Study arms

Other
Plant-based ingredient to a starchy meal
Plant-based ingredient
Dietary Supplement: plant-based ingredient · Dietary Supplement: No plant-based ingredient
Other
Starchy meal alone
No plant-based ingredient
Dietary Supplement: plant-based ingredient · Dietary Supplement: No plant-based ingredient

Interventions

Dietary supplementplant-based ingredient
Dietary supplementNo plant-based ingredient

What researchers measure

Primary outcomes

AUC of post-prandial hormones
Amylin (total) will be assessed.
Time frame: 120 minutes
AUC of post-prandial hormones
Ghrelin (active) will be assessed.
Time frame: 120 minutes
AUC of post-prandial hormones
Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.
Time frame: 120 minutes
AUC of post-prandial hormones
Glucagon-like peptide-1 (GLP-1) (active) will be assessed.
Time frame: 120 minutes
AUC of post-prandial hormones
Leptin will be assessed.
Time frame: 120 minutes
AUC of post-prandial hormones
Pancreatic polypeptide (PP) will be assessed.
Time frame: 120 minutes
AUC of post-prandial hormones
Peptide YY (PYY) (total) will be assessed.
Time frame: 120 minutes
AUC of post-prandial hormones
Insulin will be assessed.
Time frame: 120 minutes
AUC of post-prandial hormones
C-peptide will be assessed.
Time frame: 120 minutes
AUC of post-prandial hormones
Glucagon will be assessed.
Time frame: 120 minutes

Secondary outcomes

AUC of post-prandial hormones
Amylin (total) will be assessed.
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Ghrelin (active) will be assessed.
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Pancreatic polypeptide (PP) will be assessed.
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Peptide YY (PYY) (total) will be assessed.
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Leptin will be assessed.
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Glucagon will be assessed.
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Insulin will be assessed.
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
C-peptide will be assessed.
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Glucagon-like peptide-1 (GLP-1) (active) will be assessed.
Time frame: 180 and 240 minutes

Other outcomes

Blood glucose response (+iAUC)
Effect on blood glucose response.
Time frame: 120 and 180 minutes

Study locations

1 site

Eurofins Optimed Clinical research
Gieres, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02003586
Lead sponsor: Unilever R&D
Responsible party: Sponsor
First posted: Dec 6, 2013
Start date: Dec 2013
Primary completion: Jan 2014
Completion: Jan 2014
Last update: Apr 9, 2014

Study contacts

Yves DONAZZOLO, M.D., M.Sc.

principal investigator · EUROFINS OPTIMED, GIERES - France

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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