Healthy SubjectsNCT01999543
Post-prandial Glucose in Healthy Indian Subjects
A study testing plant-based dietary supplement in people with Healthy Subjects, 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 on different food formats affect blood glucose responses in healthy subjects Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- plant-based dietary supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2013to Feb 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to give consent to participate in the study in writing;
- Healthy male and female subjects, between the age of ≥20 and ≤50 yrs of age at first screening visit;
- Body Mass Index (BMI) between ≥18 and ≤ 25 kg/m2;
- Apparently healthy: no medical conditions which might affect study measurement, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
- Willing to comply to study protocol during the study;
- Agreeing to be informed about medically relevant personal test-results by study physician;
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- Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
- Fasting blood glucose value of volunteer 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)
Who cannot join
- Being an employee of Unilever or CRO;
- Chronic smokers, tobacco chewers and drinkers;
- Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
- Use of medication which interferes with study measurements including vitamins, tonics;
- Reported intense exercise ≥10 h/week;
- Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening
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- Blood donation for 2 months prior to screening;
- Urine analysis that showed any drug abuse;
- Allergy to any food or cosmetics;
- If female, not being pregnant or planning pregnancy during the study period;
- If female, lactating or has been lactating for 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: Effect of Plant-based Ingredient in Different Food Formats on Post-prandial Glucose in Healthy Indian Subjects
The study is designed to determine the extent to which a plant-based ingredient on different food formats affect blood glucose responses in healthy subjects
- Conditions
- Healthy Subjects
- Being tested
- plant-based dietary supplement, Placebo
- Keywords
- Blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant-based dietary supplementDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Reference food format | Other | reference food format with and without plant-based ingredient added Receives: Dietary Supplement: plant-based dietary supplement; Other: Placebo |
| Food format one | Experimental | Food format one with and without plant-based ingredient added Receives: Dietary Supplement: plant-based dietary supplement; Other: Placebo |
| Food format two | Experimental | Food format two with and without plant-based ingredient added Receives: Dietary Supplement: plant-based dietary supplement; Other: Placebo |
| Food format three | Experimental | Food format three with and without plant-based ingredient added Receives: Dietary Supplement: plant-based dietary supplement; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive incremental post-prandial blood glucose area under the curve
Measured: 120 minutes
Secondary outcomes (1)
Post-prandial insulin area under the curve
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- NCT01999543
- Sponsor's protocol ID
- FDS-NAA-1373
- Status last verified
- Feb 2014
- First submitted
- 25 Nov 2013
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plant-based Ingredient in Different Food Formats on Post-prandial Glucose in Healthy Indian Subjects
- ClinicalTrials.gov ID
- NCT01999543
- Acronym / sponsor ID
- FDS-NAA-1373
- Conditions
- Healthy Subjects
- Keywords
- Blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 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 a plant-based ingredient on different food formats affect blood glucose responses in healthy subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reference food format | Other | Dietary Supplement: plant-based dietary supplement, Other: Placeboreference food format with and without plant-based ingredient added |
| Food format one | Experimental | Dietary Supplement: plant-based dietary supplement, Other: PlaceboFood format one with and without plant-based ingredient added |
| Food format two | Experimental | Dietary Supplement: plant-based dietary supplement, Other: PlaceboFood format two with and without plant-based ingredient added |
| Food format three | Experimental | Dietary Supplement: plant-based dietary supplement, Other: PlaceboFood format three with and without plant-based ingredient added |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Willing to give consent to participate in the study in writing;
- Healthy male and female subjects, between the age of ≥20 and ≤50 yrs of age at first screening visit;
- Body Mass Index (BMI) between ≥18 and ≤ 25 kg/m2;
- Apparently healthy: no medical conditions which might affect study measurement, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
- Willing to comply to study protocol during the study;
Key exclusion criteria (11 listed)
- Being an employee of Unilever or CRO;
- Chronic smokers, tobacco chewers and drinkers;
- Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
- Use of medication which interferes with study measurements including vitamins, tonics;
- Reported intense exercise ≥10 h/week;
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 dietary supplement | Dietary supplement | Food format one, Food format three, Food format two, Reference food format |
| Placebo | Other | Food format one, Food format three, Food format two, Reference food format |
Primary outcome
Positive incremental post-prandial blood glucose area under the curve
Time frame: 120 minutes
1 secondary outcome
Post-prandial insulin area under the curve
Time frame: 120 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 24 Feb 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.
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 dietary supplement in people with Healthy Subjects, 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 9 inclusion and 11 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 24 Feb 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 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. 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 under 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 24 Feb 2014.