HealthyNCT02218528
Effect of a Plant-based Ingredient on Glucose Response
A study testing Plant-based ingredient and No Plant-based ingredient in people with Healthy, run by Unilever R&D at 1 site in India.
Trial summary
The study is designed to determine the extent to which a plant-based ingredient is able to modulate blood glucose response when administered with a meal. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy 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?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2014to Sep 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females, age at start of the study ≥ 18 and ≤ 50 years;
- Apparently healthy: no medical conditions which might affect the study measurements, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
- Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
- Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm/dL; both inclusive) as judged by the research physician;
- Body mass index (BMI) ≥ 18,0 and ≤ 25,0 kg/m2;
- Agreeing to be informed about medically relevant personal test-results by study physician;
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- Willing to comply to study protocol during study;
- Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
- Accessible veins on arms as determined by examination at screening;
- Being literate;
- HbA1C ≤ 6.5 % (48 mmol/mol).
Who cannot join
- Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
- Any history of gastro-intestinal disorders (including frequent diarrhoea for example);
- 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 23.00 PM and 6.00 AM;
- Reported intense sporting activities > 10h/w;
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- Consumption of ≥120 ml of alcoholic drinks for males and females in a typical week;
- Drug abuse as indicated by urine analysis;
- Chronic smokers, tobacco chewers and drinkers;
- Use of any medication, including supplements and traditional medicine;
- Reported dietary habits, such as a medically prescribed/slimming diet;
- Not being used to eat breakfast;
- Reported weight loss/gain (>10%) in the last six month before the study;
- Being an employee of Unilever or CRO;
- Allergy or intolerance to food products and aversion to food products provided during the study;
- If female: pregnant or will be planning pregnancy during the study period;
- If female: lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study of a Plant-based Ingredient for Reducing the Post-prandial Blood Glucose Response in Healthy Indian Adults, When Administered With a Meal
The study is designed to determine the extent to which a plant-based ingredient is able to modulate blood glucose response when administered with a meal.
- 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 |
|---|---|---|
| Starchy meal | Placebo comparator | No Plant-based ingredient added to a starchy meal Receives: Dietary Supplement: No Plant-based ingredient |
| Low dose added to starchy meal | Active comparator | Plant-based ingredient in low dose added to starchy meal Receives: Dietary Supplement: Plant-based ingredient |
| Starchy meal and side dish | Placebo comparator | No Plant-based ingredient added to starchy meal and side dish Receives: Dietary Supplement: No Plant-based ingredient |
| Low dose added to starchy meal and side dish | Active comparator | Plant-based ingredient in low dose added to starchy meal and side dish Receives: Dietary Supplement: Plant-based ingredient |
| Medium dose added to starchy meal and side dish | Active comparator | Plant-based ingredient in medium dose added to starchy meal and side dish Receives: Dietary Supplement: Plant-based ingredient |
| High dose added to starchy meal and side dish | Active comparator | Plant-based ingredient in high dose added to starchy meal and side dish Receives: Dietary Supplement: Plant-based ingredient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive incremental post-prandial blood glucose area unde the curve
Measured: 120 minutes
Secondary outcomes (4)
Positive incremental post-prandial blood glucose area under the curve
Measured: 180 minutes
Post-prandial insulin response
Measured: 120 minutes
Post-prandial insulin response
Measured: 180 minutes
Assessment of gastric emptying rate
GE50% (time to empty 50% of the gastric content) will be determined with paracetamol
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2014
- Study completionSep 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
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Ketul Modi, MBBS, Principal investigator, Lambda Therapeutics Research Ltd (LTRL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218528
- Sponsor's protocol ID
- FDS-NAA-1716
- Status last verified
- Aug 2014
- First submitted
- 14 Aug 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of a Plant-based Ingredient for Reducing the Post-prandial Blood Glucose Response in Healthy Indian Adults, When Administered With a Meal
- ClinicalTrials.gov ID
- NCT02218528
- Acronym / sponsor ID
- FDS-NAA-1716
- Conditions
- Healthy
- Keywords
- subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Aug 2014 (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 a plant-based ingredient is able to modulate blood glucose response when administered with a meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Starchy meal | Placebo comparator | Dietary Supplement: No Plant-based ingredientNo Plant-based ingredient added to a starchy meal |
| Low dose added to starchy meal | Active comparator | Dietary Supplement: Plant-based ingredientPlant-based ingredient in low dose added to starchy meal |
| Starchy meal and side dish | Placebo comparator | Dietary Supplement: No Plant-based ingredientNo Plant-based ingredient added to starchy meal and side dish |
| Low dose added to starchy meal and side dish | Active comparator | Dietary Supplement: Plant-based ingredientPlant-based ingredient in low dose added to starchy meal and side dish |
| Medium dose added to starchy meal and side dish | Active comparator | Dietary Supplement: Plant-based ingredientPlant-based ingredient in medium dose added to starchy meal and side dish |
| High dose added to starchy meal and side dish | Active comparator | Dietary Supplement: Plant-based ingredientPlant-based ingredient in high dose added to starchy meal and side dish |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy males and females, age at start of the study ≥ 18 and ≤ 50 years;
- Apparently healthy: no medical conditions which might affect the study measurements, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
- Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
- Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm/dL; both inclusive) as judged by the research physician;
- Body mass index (BMI) ≥ 18,0 and ≤ 25,0 kg/m2;
Key exclusion criteria (17 listed)
- Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
- Any history of gastro-intestinal disorders (including frequent diarrhoea for example);
- 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 23.00 PM and 6.00 AM;
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 | High dose added to starchy meal and side dish, Low dose added to starchy meal, Low dose added to starchy meal and side dish, Medium dose added to starchy meal and side dish |
| No Plant-based ingredient | Dietary supplement | Starchy meal, Starchy meal and side dish |
Primary outcome
Positive incremental post-prandial blood glucose area unde the curve
Time frame: 120 minutes
4 secondary outcomes
Positive incremental post-prandial blood glucose area under the curve
Time frame: 180 minutes
Post-prandial insulin response
Time frame: 120 minutes
Post-prandial insulin response
Time frame: 180 minutes
Assessment of gastric emptying rate
Time frame: 10 hours
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 18 Feb 2015.
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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.
Dr. Ketul Modi, MBBS principal investigator
Lambda Therapeutics Research Ltd (LTRL)
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 India.
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 11 inclusion and 17 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 18 Feb 2015. 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 India. 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. Some participants in this study may receive a placebo. 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?
Positive incremental post-prandial blood glucose area unde the curve (time frame: 120 minutes). 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 18 Feb 2015.