HealthyNCT01734590
Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood
A study testing Carbohydrate based food mix 1 and Carbohydrate based food mix 2 in people with Healthy, run by Unilever R&D at 1 site in Netherlands.
Trial summary
Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design. The main objective is to identify one or two flour compositions in a carbohydrate-based food that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative absorption of exogenous glucose compared to… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Carbohydrate based food mix 1 and Carbohydrate based food mix 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2012to Dec 2012
- 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
- Men only
- Healthy volunteers accepted
- Adult
- healthy males
- Age at start of the study ≥18 and ≤ 50 years
- Not smoking
- Body mass index (BMI) ≥ 20 and ≤ 28 kg/m2
- Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood.
Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design.
The main objective is to identify one or two flour compositions in a carbohydrate-based food that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative absorption of exogenous glucose compared to the control.
Read the detailed description
Twelve volunteers will participate in the study; each person will be studied on three different occasions at least one week apart, consuming the three different test products in a randomized order. Test products are carbohydrate-based food made from different flour mixes differing in their expected rate of intestinal starch digestion. The products are labeled with 13C starch.
- Conditions
- Healthy
- Being tested
- Carbohydrate based food mix 1, Carbohydrate based food mix 2, Control carbohydrate based food
- Keywords
- Flour,, carbohydrate,, digestibility, subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate based food mix 1Dietary supplement
Also called Slowly digestible carbohydrate
Carbohydrate based food
Carbohydrate based food mix 2Dietary supplement
Also called Slowly digestible carbohydrate
Carbohydrate based food
Control carbohydrate based foodDietary supplement
Also called Rapidly digestible carbohydrate
Carbohydrate based food
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate based food mix 1 | Experimental | Slowly digestible carbohydrate Receives: Dietary Supplement: Carbohydrate based food mix 2; Dietary Supplement: Control carbohydrate based food |
| Carbohydrate based food mix 2 | Experimental | Slowly digestible carbohydrate Receives: Dietary Supplement: Carbohydrate based food mix 1; Dietary Supplement: Control carbohydrate based food |
| Control carbohydrate based food | Active comparator | Rapidly digestible carbohydrate Receives: Dietary Supplement: Carbohydrate based food mix 1; Dietary Supplement: Carbohydrate based food mix 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique.
Measured: Measured during 360 min for 3 periods
Secondary outcomes (1)
Total blood glucose and insulin
Measured: Measured during 360 min for 3 periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khalid Abd-Elaziz, Principal investigator, QPS Netherlands BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734590
- Sponsor's protocol ID
- FDS-NAA-0758
- Status last verified
- Jun 2013
- First submitted
- 21 Nov 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood.
- ClinicalTrials.gov ID
- NCT01734590
- Acronym / sponsor ID
- FDS-NAA-0758
- Conditions
- Healthy
- Keywords
- Flour,, carbohydrate,, digestibility, subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Nov 2012 (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.
Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design.
The main objective is to identify one or two flour compositions in a carbohydrate-based food that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative absorption of exogenous glucose compared to the control.
Detailed description
Twelve volunteers will participate in the study; each person will be studied on three different occasions at least one week apart, consuming the three different test products in a randomized order. Test products are carbohydrate-based food made from different flour mixes differing in their expected rate of intestinal starch digestion. The products are labeled with 13C starch.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate based food mix 1 | Experimental | Dietary Supplement: Carbohydrate based food mix 2, Dietary Supplement: Control carbohydrate based foodSlowly digestible carbohydrate |
| Carbohydrate based food mix 2 | Experimental | Dietary Supplement: Carbohydrate based food mix 1, Dietary Supplement: Control carbohydrate based foodSlowly digestible carbohydrate |
| Control carbohydrate based food | Active comparator | Dietary Supplement: Carbohydrate based food mix 1, Dietary Supplement: Carbohydrate based food mix 2Rapidly digestible carbohydrate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Carbohydrate based food mix 1Also: Slowly digestible carbohydrateCarbohydrate based food | Dietary supplement | Carbohydrate based food mix 2, Control carbohydrate based food |
| Carbohydrate based food mix 2Also: Slowly digestible carbohydrateCarbohydrate based food | Dietary supplement | Carbohydrate based food mix 1, Control carbohydrate based food |
| Control carbohydrate based foodAlso: Rapidly digestible carbohydrateCarbohydrate based food | Dietary supplement | Carbohydrate based food mix 1, Carbohydrate based food mix 2 |
Primary outcome
Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique.
Time frame: Measured during 360 min for 3 periods
1 secondary outcome
Total blood glucose and insulin
Time frame: Measured during 360 min for 3 periods
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 Jun 2013.
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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.
Khalid Abd-Elaziz principal investigator
QPS Netherlands BV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate based food mix 1 and Carbohydrate based food mix 2 in people with Healthy, run by Unilever R&D at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Jun 2013. 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 Netherlands. 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?
Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique. (time frame: Measured during 360 min for 3 periods). 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 Jun 2013.