HealthyNCT02003586
Effect of a Plant-based Ingredient on Generalized Hormonal Responses
A study testing plant-based ingredient and No plant-based ingredient in people with Healthy, run by Unilever R&D at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- plant-based ingredient and No plant-based ingredient
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Healthy
- Being tested
- plant-based ingredient, No plant-based ingredient
- Keywords
- subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant-based ingredientDietary supplement
No plant-based ingredientDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Plant-based ingredient to a starchy meal | Other | Plant-based ingredient Receives: Dietary Supplement: plant-based ingredient; Dietary Supplement: No plant-based ingredient |
| Starchy meal alone | Other | No plant-based ingredient Receives: Dietary Supplement: plant-based ingredient; Dietary Supplement: No plant-based ingredient |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of post-prandial hormones
Amylin (total) will be assessed.
Measured: 120 minutes
AUC of post-prandial hormones
Ghrelin (active) will be assessed.
Measured: 120 minutes
AUC of post-prandial hormones
Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.
Measured: 120 minutes
AUC of post-prandial hormones
Glucagon-like peptide-1 (GLP-1) (active) will be assessed.
Measured: 120 minutes
AUC of post-prandial hormones
Leptin will be assessed.
Measured: 120 minutes
AUC of post-prandial hormones
Pancreatic polypeptide (PP) will be assessed.
Measured: 120 minutes
AUC of post-prandial hormones
Peptide YY (PYY) (total) will be assessed.
Measured: 120 minutes
AUC of post-prandial hormones
Insulin will be assessed.
Measured: 120 minutes
AUC of post-prandial hormones
C-peptide will be assessed.
Measured: 120 minutes
AUC of post-prandial hormones
Glucagon will be assessed.
Measured: 120 minutes
Secondary outcomes (10)
AUC of post-prandial hormones
Amylin (total) will be assessed.
Measured: 180 and 240 minutes
AUC of post-prandial hormones
Ghrelin (active) will be assessed.
Measured: 180 and 240 minutes
AUC of post-prandial hormones
Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.
Measured: 180 and 240 minutes
AUC of post-prandial hormones
Pancreatic polypeptide (PP) will be assessed.
Measured: 180 and 240 minutes
AUC of post-prandial hormones
Peptide YY (PYY) (total) will be assessed.
Measured: 180 and 240 minutes
AUC of post-prandial hormones
Leptin will be assessed.
Measured: 180 and 240 minutes
AUC of post-prandial hormones
Glucagon will be assessed.
Measured: 180 and 240 minutes
AUC of post-prandial hormones
Insulin will be assessed.
Measured: 180 and 240 minutes
AUC of post-prandial hormones
C-peptide will be assessed.
Measured: 180 and 240 minutes
AUC of post-prandial hormones
Glucagon-like peptide-1 (GLP-1) (active) will be assessed.
Measured: 180 and 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves DONAZZOLO, M.D., M.Sc., Principal investigator, EUROFINS OPTIMED, GIERES - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003586
- Sponsor's protocol ID
- FDS-NAA-1462
- Status last verified
- Jan 2014
- First submitted
- 22 Nov 2013
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Plant-based Ingredient on Generalized Hormonal Responses
- ClinicalTrials.gov ID
- NCT02003586
- Acronym / sponsor ID
- FDS-NAA-1462
- Conditions
- Healthy
- Keywords
- subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant-based ingredient to a starchy meal | Other | Dietary Supplement: plant-based ingredient, Dietary Supplement: No plant-based ingredientPlant-based ingredient |
| Starchy meal alone | Other | Dietary Supplement: plant-based ingredient, Dietary Supplement: No plant-based ingredientNo plant-based ingredient |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plant-based ingredient | Dietary supplement | Plant-based ingredient to a starchy meal, Starchy meal alone |
| No plant-based ingredient | Dietary supplement | Plant-based ingredient to a starchy meal, Starchy meal alone |
Primary outcome
AUC of post-prandial hormones
Time frame: 120 minutes
Amylin (total) will be assessed.
AUC of post-prandial hormones
Time frame: 120 minutes
Ghrelin (active) will be assessed.
AUC of post-prandial hormones
Time frame: 120 minutes
Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.
AUC of post-prandial hormones
Time frame: 120 minutes
Glucagon-like peptide-1 (GLP-1) (active) will be assessed.
AUC of post-prandial hormones
Time frame: 120 minutes
Leptin will be assessed.
AUC of post-prandial hormones
Time frame: 120 minutes
Pancreatic polypeptide (PP) will be assessed.
AUC of post-prandial hormones
Time frame: 120 minutes
Peptide YY (PYY) (total) will be assessed.
AUC of post-prandial hormones
Time frame: 120 minutes
Insulin will be assessed.
AUC of post-prandial hormones
Time frame: 120 minutes
C-peptide will be assessed.
AUC of post-prandial hormones
Time frame: 120 minutes
Glucagon will be assessed.
10 secondary outcomes
AUC of post-prandial hormones
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Time frame: 180 and 240 minutes
AUC of post-prandial hormones
Time frame: 180 and 240 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves DONAZZOLO, M.D., M.Sc. principal investigator
EUROFINS OPTIMED, GIERES - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plant-based ingredient and No plant-based ingredient in people with Healthy, run by Unilever R&D at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of post-prandial hormones (time frame: 120 minutes). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.