NCT02003586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 9, 2014

Status Verified

January 1, 2014

Enrollment Period

1 month

First QC Date

November 22, 2013

Last Update Submit

April 8, 2014

Conditions

Healthy

Keywords

subjects

Outcome Measures

Primary Outcomes (10)

  • AUC of post-prandial hormones

    Amylin (total) will be assessed.

    120 minutes

  • AUC of post-prandial hormones

    Ghrelin (active) will be assessed.

    120 minutes

  • AUC of post-prandial hormones

    Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.

    120 minutes

  • AUC of post-prandial hormones

    Glucagon-like peptide-1 (GLP-1) (active) will be assessed.

    120 minutes

  • AUC of post-prandial hormones

    Leptin will be assessed.

    120 minutes

  • AUC of post-prandial hormones

    Pancreatic polypeptide (PP) will be assessed.

    120 minutes

  • AUC of post-prandial hormones

    Peptide YY (PYY) (total) will be assessed.

    120 minutes

  • AUC of post-prandial hormones

    Insulin will be assessed.

    120 minutes

  • AUC of post-prandial hormones

    C-peptide will be assessed.

    120 minutes

  • AUC of post-prandial hormones

    Glucagon will be assessed.

    120 minutes

Secondary Outcomes (10)

  • AUC of post-prandial hormones

    180 and 240 minutes

  • AUC of post-prandial hormones

    180 and 240 minutes

  • AUC of post-prandial hormones

    180 and 240 minutes

  • AUC of post-prandial hormones

    180 and 240 minutes

  • AUC of post-prandial hormones

    180 and 240 minutes

  • +5 more secondary outcomes

Other Outcomes (1)

  • Blood glucose response (+iAUC)

    120 and 180 minutes

Study Arms (2)

Plant-based ingredient to a starchy meal

OTHER

Plant-based ingredient

Dietary Supplement: plant-based ingredientDietary Supplement: No plant-based ingredient

Starchy meal alone

OTHER

No plant-based ingredient

Dietary Supplement: plant-based ingredientDietary Supplement: No plant-based ingredient

Interventions

plant-based ingredientDIETARY_SUPPLEMENT
Plant-based ingredient to a starchy mealStarchy meal alone
No plant-based ingredientDIETARY_SUPPLEMENT
Plant-based ingredient to a starchy mealStarchy meal alone

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurofins Optimed Clinical research

Gières, France

Location

Study Officials

  • Yves DONAZZOLO, M.D., M.Sc.

    EUROFINS OPTIMED, GIERES - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2013

First Posted

December 6, 2013

Study Start

December 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 9, 2014

Record last verified: 2014-01

Locations

FR(1)