HealthyNCT02814357
To Test the Effect of Selected Fibres and Flours in Flat Bread on Post-Prandial Blood Glucose and Insulin Responses in Healthy Indian Population
A study testing wheat flour, chickpea flour and guar gum in people with Healthy, run by Unilever R&D at 1 site in India.
Trial summary
Double-blind, randomized, controlled, cross-over design with 3 test products and one control product. To evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour 15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG) and serum insulin levels in… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- wheat flour, chickpea flour and guar gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2011to Jul 2011
- 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
- Healthy male and female subjects between > 20 and < 50 years of age
- BMI of >18 and < 23 kg/m2
- Fasting blood glucose value of volunteer is > 3.4 and <6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening
Who cannot join
- Chronic smokers, tobacco chewers and drinkers.
Trial locations and contacts
1 site in 1 country.
India1 site
Lambda Therapeutics Research Ltd (LTRL)
Ahmedabad, Near Gujrat High Court, SG Highway, Gota, 380 061 Gujrat
About this study
Official title: To Evaluate the Effect of 4 Different Flour Compositions of Selected Fibres and Flours, on Post-prandial Plasma Glucose (PPG) and Serum Insulin Levels in Normal Indian Healthy Subjects
Double-blind, randomized, controlled, cross-over design with 3 test products and one control product.
To evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour 15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG) and serum insulin levels in healthy Indian subjects, after the consumption of flat bread made from 100 gram of flour compositions.
- Conditions
- Healthy
- Being tested
- Control (market standard), wheat flour, chickpea flour, guar gum, barley
- Keywords
- Blood glucose, serum insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (market standard)Other
wheat flourOther
chickpea flourOther
guar gumOther
barleyOther
| Study group | Role | What they receive |
|---|---|---|
| Control (market standard) | Placebo comparator | 100 g wheat flour (atta) Receives: Other: Control (market standard) |
| High fibre 1 | Active comparator | 81% wheat flour (atta) + 15% chickpea + 4% guar gum Receives: Other: wheat flour; Other: chickpea flour; Other: guar gum |
| High fibre 2 | Active comparator | 80% wheat flour (atta) + 15% chickpea + 2% guar gum + 3% barley Receives: Other: wheat flour; Other: chickpea flour; Other: guar gum; Other: barley |
| High fibre 3 | Active comparator | 77% wheat flour (atta) + 15% chickpea + 3% guar gum + 5% barley Receives: Other: wheat flour; Other: chickpea flour; Other: guar gum; Other: barley |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive incremental area under blood glucose curve
Measured: 0-120 minutes
Secondary outcomes (1)
Total area under the serum insulin curve
Measured: 0-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startJul 2011
- Primary completionJul 2011
- Study completionJul 2011
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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rakesh Patel, Dr., Principal investigator, Lambda Therapeutic Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814357
- Sponsor's protocol ID
- FDS-NAA-0224
- Status last verified
- Jul 2016
- First submitted
- 23 Jun 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effect of 4 Different Flour Compositions of Selected Fibres and Flours, on Post-prandial Plasma Glucose (PPG) and Serum Insulin Levels in Normal Indian Healthy Subjects
- ClinicalTrials.gov ID
- NCT02814357
- Acronym / sponsor ID
- FDS-NAA-0224
- Conditions
- Healthy
- Keywords
- Blood glucose, serum insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Jun 2016 (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.
Double-blind, randomized, controlled, cross-over design with 3 test products and one control product.
To evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour 15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG) and serum insulin levels in healthy Indian subjects, after the consumption of flat bread made from 100 gram of flour compositions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control (market standard) | Placebo comparator | Other: Control (market standard)100 g wheat flour (atta) |
| High fibre 1 | Active comparator | Other: wheat flour, Other: chickpea flour, Other: guar gum81% wheat flour (atta) + 15% chickpea + 4% guar gum |
| High fibre 2 | Active comparator | Other: wheat flour, Other: chickpea flour, Other: guar gum, Other: barley80% wheat flour (atta) + 15% chickpea + 2% guar gum + 3% barley |
| High fibre 3 | Active comparator | Other: wheat flour, Other: chickpea flour, Other: guar gum, Other: barley77% wheat flour (atta) + 15% chickpea + 3% guar gum + 5% barley |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects between > 20 and < 50 years of age
- BMI of >18 and < 23 kg/m2
- Fasting blood glucose value of volunteer is > 3.4 and <6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening
Key exclusion criteria (1 listed)
- Chronic smokers, tobacco chewers and drinkers.
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 |
|---|---|---|
| Control (market standard) | Other | Control (market standard) |
| wheat flour | Other | High fibre 1, High fibre 2, High fibre 3 |
| chickpea flour | Other | High fibre 1, High fibre 2, High fibre 3 |
| guar gum | Other | High fibre 1, High fibre 2, High fibre 3 |
| barley | Other | High fibre 2, High fibre 3 |
Primary outcome
Positive incremental area under blood glucose curve
Time frame: 0-120 minutes
1 secondary outcome
Total area under the serum insulin curve
Time frame: 0-120 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 19 Jul 2016.
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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.
Rakesh Patel, Dr. principal investigator
Lambda Therapeutic Research Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wheat flour, chickpea flour and guar gum 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 3 inclusion and 1 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 19 Jul 2016. 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 area under blood glucose curve (time frame: 0-120 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 19 Jul 2016.