Diabetes Mellitus, Type 2NCT02256332
Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes
A study testing Low dose plant based ingredient, High dose plant based ingredient and Reference food format in people with Diabetes Mellitus, Type 2, run by Unilever R&D at 2 sites in India.
Trial summary
Effects of a plant based ingredient on blood glucose in Type II diabetes patients. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Low dose plant based ingredient, High dose plant based ingredient and Reference food format
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesIndia
- Study dates
- Jan 2015to Aug 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female volunteers with confirmed Type II diabetes not treated with pharmaceutical-based glucose lowering treatment for past three months (controlled solely through diet and exercise);
- Age ≥ 20 and ≤ 65 year at screening;
- Body Mass Index (BMI) between ≥18 and ≤ 32 kg/m2;
- HbA1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). At discretion of the study physician, subjects with HbA1c >53 mmol/mol and <58 mmol/mol (>7.0% and < 7.5%) controlled solely through diet and exercise are also allowed to participate.
Who cannot join
- Being an employee of Unilever or research site;
- Chronic smokers, tobacco chewers and drinkers;
- No medication, including vitamins and tonics, except for cholesterol, as determined by the physician;
- Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;
- 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
2 sites in 1 country.
India2 sites
Lambda Therapeutics Research Ttd (LTRL)
Ahemdabad
Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA
Thane, Maharashtra
About this study
Official title: Effect of Plant-based Ingredient on Post Prandial Glucose in Untreated Type II Diabetes Patients
Effects of a plant based ingredient on blood glucose in Type II diabetes patients.
Read the detailed description
The study is designed to determine the extend to which a plant based ingredient in a food format affects blood glucose responses in untreated Type II diabetes patients.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Low dose plant based ingredient, High dose plant based ingredient, Reference food format
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose plant based ingredientDietary supplement
Reference food with low dose of plant based ingredient
High dose plant based ingredientDietary supplement
Reference food with high dose of plant based ingredient
Reference food formatDietary supplement
Reference food without plant-based ingredient
| Study group | Role | What they receive |
|---|---|---|
| Low dose plant based ingredient | Active comparator | Reference food with low dose of plant based ingredient Receives: Dietary Supplement: Low dose plant based ingredient |
| High dose plant based ingredient | Active comparator | Reference food with high dose of plant based ingredient Receives: Dietary Supplement: High dose plant based ingredient |
| Reference food format | Placebo comparator | Reference food without plant-based ingredient Receives: Dietary Supplement: Reference food format |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post prandial blood glucose positive incremental 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 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 24 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)Dr Shrikant V Deshpande, Principal investigator, Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256332
- Sponsor's protocol ID
- FDS-NAA-1633
- Status last verified
- Sep 2015
- First submitted
- 30 Sep 2014
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plant-based Ingredient on Post Prandial Glucose in Untreated Type II Diabetes Patients
- ClinicalTrials.gov ID
- NCT02256332
- Acronym / sponsor ID
- FDS-NAA-1633
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Oct 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.
Effects of a plant based ingredient on blood glucose in Type II diabetes patients.
Detailed description
The study is designed to determine the extend to which a plant based ingredient in a food format affects blood glucose responses in untreated Type II diabetes patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose plant based ingredient | Active comparator | Dietary Supplement: Low dose plant based ingredientReference food with low dose of plant based ingredient |
| High dose plant based ingredient | Active comparator | Dietary Supplement: High dose plant based ingredientReference food with high dose of plant based ingredient |
| Reference food format | Placebo comparator | Dietary Supplement: Reference food formatReference food without plant-based ingredient |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female volunteers with confirmed Type II diabetes not treated with pharmaceutical-based glucose lowering treatment for past three months (controlled solely through diet and exercise);
- Age ≥ 20 and ≤ 65 year at screening;
- Body Mass Index (BMI) between ≥18 and ≤ 32 kg/m2;
- HbA1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). At discretion of the study physician, subjects with HbA1c >53 mmol/mol and <58 mmol/mol (>7.0% and < 7.5%) controlled solely through diet and exercise are also allowed to participate.
Key exclusion criteria (7 listed)
- Being an employee of Unilever or research site;
- Chronic smokers, tobacco chewers and drinkers;
- No medication, including vitamins and tonics, except for cholesterol, as determined by the physician;
- Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;
- Allergy to any food or cosmetics;
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 |
|---|---|---|
| Low dose plant based ingredientReference food with low dose of plant based ingredient | Dietary supplement | Low dose plant based ingredient |
| High dose plant based ingredientReference food with high dose of plant based ingredient | Dietary supplement | High dose plant based ingredient |
| Reference food formatReference food without plant-based ingredient | Dietary supplement | Reference food format |
Primary outcome
Post prandial blood glucose positive incremental 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 23 Sep 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)
Dr Shrikant V Deshpande principal investigator
Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose plant based ingredient, High dose plant based ingredient and Reference food format in people with Diabetes Mellitus, Type 2, run by Unilever R&D at 2 sites 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 4 inclusion and 7 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 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Post prandial blood glucose positive incremental 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 23 Sep 2015.