HealthyNCT02671214
The Effect of Selected Fibres and Flours in Flat Bread on Post-prandial Blood Glucose Responses
A study testing Active 2, Active 3 and Active 4 in people with Healthy, run by Unilever R&D at 1 site in United Kingdom.
Trial summary
Identify one or more flat bread mixes that produce a reduction in positive incremental area under the curve (iAUC) of post-prandial glucose relative to the control product. 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?
- Active 2, Active 3 and Active 4
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Jan 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
- Body mass index (BMI) ≥ 20 and ≤ 25.0 kg/m2.
- Apparently healthy: no medical conditions which might affect study measurements (as judged by the study physician).
- A fasting blood glucose value between 3.5 - 5.6 mmol/litre at screening (measured by finger prick).
Who cannot join
- Use of medication which interferes with study measurements (as judged by the study physician).
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leatherhead Food Research UK
Leatherhead, Randalls Road, Surrey, KT22 7RY
About this study
Identify one or more flat bread mixes that produce a reduction in positive incremental area under the curve (iAUC) of post-prandial glucose relative to the control product.
Read the detailed description
This study was a double-blind, randomised, balanced incomplete block design exploratory study of efficacy, with 11 active treatments compared to a control product in 42 healthy subjects to see if a mix of active ingredients (viscous fibres and flours) lowered the post-prandial glucose (PPG) response in capillary blood (finger prick) over a two and three hours period, relative to the control product. Every subject received the control and 4 out of the 11 treatments on five separate test days.
- Conditions
- Healthy
- Being tested
- Control, Active 2, Active 3, Active 4, Active 5
- Keywords
- guar gum, konjac mannan, blood glucose, legume flour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
100 g high fibre flour
Active 2Other
98 g high fibre flour + 2 g guar gum
Active 3Other
88 g high fibre flour + 2 g guar gum + 10 g legume flour
Active 4Other
83 g high fibre flour + 2 g guar gum + 15 g legume flour
Active 5Other
96 g high fibre flour + 4 g guar gum
Active 6Other
86 g high fibre flour + 4 g guar gum + 10 g legume flour
Active 7Other
81 g high fibre flour + 4 g guar gum + 15 g legume flour
Active 8Other
94 g high fibre flour + 6 g guar gum
Active 9Other
98 g high fibre flour + 2 g konjac mannan
Active 10Other
96 g high fibre flour + 4 g konjac mannan
Active 11Other
100 g low fibre flour
Active 1Other
85 g high fibre flour + 15 g legume flour
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 100 g high fibre flour Receives: Other: Control |
| Active 1 | Active comparator | 85 g high fibre flour + 15 g legume flour Receives: Other: Active 1 |
| Active 2 | Active comparator | 98 g high fibre flour + 2 g guar gum Receives: Other: Active 2 |
| Active 3 | Active comparator | 88 g high fibre flour + 2 g guar gum + 10 g legume flour Receives: Other: Active 3 |
| Active 4 | Active comparator | 83 g high fibre flour + 2 g guar gum + 15 g legume flour Receives: Other: Active 4 |
| Active 5 | Active comparator | 96 g high fibre flour + 4 g guar gum Receives: Other: Active 5 |
| Active 6 | Active comparator | 86 g high fibre flour + 4 g guar gum + 10 g legume flour Receives: Other: Active 6 |
| Active 7 | Active comparator | 81 g high fibre flour + 4 g guar gum + 15 g legume flour Receives: Other: Active 7 |
| Active 8 | Active comparator | 94 g high fibre flour + 6 g guar gum Receives: Other: Active 8 |
| Active 9 | Active comparator | 98 g high fibre flour + 2 g konjac mannan Receives: Other: Active 9 |
| Active 10 | Active comparator | 96 g high fibre flour + 4 g konjac mannan Receives: Other: Active 10 |
| Active 11 | Active comparator | 100 g low fibre flour Receives: Other: Active 11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive incremental area under the curve (iAUC)
Measured: 120 minutes
Secondary outcomes (1)
Positive incremental area under the curve (iAUC)
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startNov 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Hull, Principal investigator, Leatherhead Food Research UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671214
- Sponsor's protocol ID
- 10020V
- Status last verified
- Jan 2016
- First submitted
- 28 Jan 2016
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Boers HM, MacAulay K, Murray P, Seijen Ten Hoorn J, Hoogenraad AR, Peters HPF, Vente-Spreeuwenberg MAM, Mela DJ. Efficacy of different fibres and flour mixes in South-Asian flatbreads for reducing post-prandial glucose responses in healthy adults. Eur J Nutr. 2017 Sep;56(6):2049-2060. doi: 10.1007/s00394-016-1242-9. Epub 2016 Jun 21.
PubMed 27324141
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Selected Fibres and Flours in Flat Bread on Post-prandial Blood Glucose Responses
- ClinicalTrials.gov ID
- NCT02671214
- Acronym / sponsor ID
- 10020V
- Conditions
- Healthy
- Keywords
- guar gum, konjac mannan, blood glucose, legume flour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 2 Feb 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.
Identify one or more flat bread mixes that produce a reduction in positive incremental area under the curve (iAUC) of post-prandial glucose relative to the control product.
Detailed description
This study was a double-blind, randomised, balanced incomplete block design exploratory study of efficacy, with 11 active treatments compared to a control product in 42 healthy subjects to see if a mix of active ingredients (viscous fibres and flours) lowered the post-prandial glucose (PPG) response in capillary blood (finger prick) over a two and three hours period, relative to the control product. Every subject received the control and 4 out of the 11 treatments on five separate test days.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control100 g high fibre flour |
| Active 1 | Active comparator | Other: Active 185 g high fibre flour + 15 g legume flour |
| Active 2 | Active comparator | Other: Active 298 g high fibre flour + 2 g guar gum |
| Active 3 | Active comparator | Other: Active 388 g high fibre flour + 2 g guar gum + 10 g legume flour |
| Active 4 | Active comparator | Other: Active 483 g high fibre flour + 2 g guar gum + 15 g legume flour |
| Active 5 | Active comparator | Other: Active 596 g high fibre flour + 4 g guar gum |
| Active 6 | Active comparator | Other: Active 686 g high fibre flour + 4 g guar gum + 10 g legume flour |
| Active 7 | Active comparator | Other: Active 781 g high fibre flour + 4 g guar gum + 15 g legume flour |
| Active 8 | Active comparator | Other: Active 894 g high fibre flour + 6 g guar gum |
| Active 9 | Active comparator | Other: Active 998 g high fibre flour + 2 g konjac mannan |
| Active 10 | Active comparator | Other: Active 1096 g high fibre flour + 4 g konjac mannan |
| Active 11 | Active comparator | Other: Active 11100 g low fibre flour |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) ≥ 20 and ≤ 25.0 kg/m2.
- Apparently healthy: no medical conditions which might affect study measurements (as judged by the study physician).
- A fasting blood glucose value between 3.5 - 5.6 mmol/litre at screening (measured by finger prick).
Key exclusion criteria (3 listed)
- Use of medication which interferes with study measurements (as judged by the study physician).
- 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
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 |
|---|---|---|
| Control100 g high fibre flour | Other | Control |
| Active 298 g high fibre flour + 2 g guar gum | Other | Active 2 |
| Active 388 g high fibre flour + 2 g guar gum + 10 g legume flour | Other | Active 3 |
| Active 483 g high fibre flour + 2 g guar gum + 15 g legume flour | Other | Active 4 |
| Active 596 g high fibre flour + 4 g guar gum | Other | Active 5 |
| Active 686 g high fibre flour + 4 g guar gum + 10 g legume flour | Other | Active 6 |
| Active 781 g high fibre flour + 4 g guar gum + 15 g legume flour | Other | Active 7 |
| Active 894 g high fibre flour + 6 g guar gum | Other | Active 8 |
| Active 998 g high fibre flour + 2 g konjac mannan | Other | Active 9 |
| Active 1096 g high fibre flour + 4 g konjac mannan | Other | Active 10 |
| Active 11100 g low fibre flour | Other | Active 11 |
| Active 185 g high fibre flour + 15 g legume flour | Other | Active 1 |
Primary outcome
Positive incremental area under the curve (iAUC)
Time frame: 120 minutes
1 secondary outcome
Positive incremental area under the curve (iAUC)
Time frame: 180 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 2 Feb 2016.
- Derived from this study: PubMed 27324141Boers HM, MacAulay K, Murray P, Seijen Ten Hoorn J, Hoogenraad AR, Peters HPF, Vente-Spreeuwenberg MAM, Mela DJ. Efficacy of different fibres and flour mixes in South-Asian flatbreads for reducing post-prandial glucose responses in healthy adults. Eur J Nutr. 2017 Sep;56(6):2049-2060. doi: 10.1007/s00394-016-1242-9. Epub 2016 Jun 21.
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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.
Sarah Hull principal investigator
Leatherhead Food Research UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active 2, Active 3 and Active 4 in people with Healthy, run by Unilever R&D at 1 site in United Kingdom.
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 3 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 2 Feb 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 United Kingdom. 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 the curve (iAUC) (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02671214, which also lists 1 linked publication.
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 2 Feb 2016.