HyperglycemiaNCT02075788
Millet Products Study - Investigation of Glycemic Index and Satiety
A study testing Commercial white bread, Corn based products (porridge etc.) and Millet based products (porridge etc.) in people with Hyperglycemia and Lack of Satiety, run by University of Guelph at 1 site in Canada.
Trial summary
The purpose of this study is to investigate how millet incorporation into different baked product types influences glycemic response and satiety. Read more about this study
- Who is it for?
- Ages 19 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Lack of Satiety
- What is being tested?
- Commercial white bread, Corn based products (porridge etc.) and Millet based products (porridge etc.)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Jun 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 19 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men, age 19-40, non-smoking
- Normal fasting plasma glucose (<5.6 mmol/L but not below 3.6 mmol/L)
- Normal glucose tolerance (evaluated by a 75 g oral glucose test, i.e. <7.8 mmol/L but not below 3.6 mmol/L)
- BMI ranging from 18.5 to 29.9 kg/m2
Who cannot join
- Insulin resistance (IR) will be calculated from fasting glucose and insulin values using the Homeostasis Assessment Model 2 (HOMA2). A HOMA2-IR value of greater than 1.0 will be considered indicative of insulin resistance (Levy J.C. et al. 1998).
- Regular consumption of millet as defined by questionnaire at screening defined as more than 1x per week
- Smoking or use of recreational drugs
- Heavy alcohol use (defined as typically >14 drinks per week or >4 drinks on one occasion)
- Very low fibre consumption as assessed by 24 hour food diary and self-reported fruit/vegetable/whole grain servings.
- Restrained eater as defined by the questionnaire at screening (Three Factor Eating Questionnaire, Stunkard et al.,1985)
Show all 14Show fewer
- Food neophobic defined by Food Neophobia Scale questionnaire
- Unusual sleep patterns or irregular breakfast consumption
- Recent (i.e. >4 kg in previous 3 months) or intended weight loss or gain
- Food allergies or any life-threatening allergy (food or otherwise)
- Inflammatory bowel disease or other gastrointestinal disorders
- Use of drugs which influence carbohydrate metabolism
- Training or elite athletes
- Inability to adhere to Study Protocols
Trial locations and contacts
1 site in 1 country.
Canada1 site
Human Nutraceutical Research Unit, University of Guelph
Guelph, Ontario, N1G2W1
About this study
The purpose of this study is to investigate how millet incorporation into different baked product types influences glycemic response and satiety.
Read the detailed description
The purpose of this study is to investigate how millet incorporation into different baked product types (i.e. an extruded snack versus a biscuit) influences glycemic response and satiety.
This project will examine the effect of millet, on glycemic response and satiety. To determine the effect of product matrix and processing methods, testing will be done using an extruded snack, porridge, a couscous-like product and a biscuit.
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
- Conditions
- Hyperglycemia, Lack of Satiety
- Being tested
- Commercial white bread, Corn based products (porridge etc.), Millet based products (porridge etc.)
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial white breadOther
Corn based products (porridge etc.)Other
Millet based products (porridge etc.)Other
| Study group | Role | What they receive |
|---|---|---|
| Commercial white bread | Placebo comparator | All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes. Receives: Other: Commercial white bread |
| Millet based products (porridge etc.) | Experimental | All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes. Receives: Other: Millet based products (porridge etc.) |
| Corn based products (porridge etc.) | Active comparator | All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes. Receives: Other: Corn based products (porridge etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of glycemic index based on collection of capillary plasma glucose
Measured: Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes
Secondary outcomes (1)
Self reported ratings of satiety
Measured: Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Bunge Global Innovation Incorporated
- Responsible party
- Principal investigator, Amanda Wright, Ph.D., University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075788
- Sponsor's protocol ID
- 13AP004
- Status last verified
- Jan 2016
- First submitted
- 26 Feb 2014
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Millet Products Study - Investigation of Glycemic Index and Satiety
- ClinicalTrials.gov ID
- NCT02075788
- Acronym / sponsor ID
- 13AP004
- Conditions
- Hyperglycemia, Lack of Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Bunge Global Innovation Incorporated
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Mar 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.
The purpose of this study is to investigate how millet incorporation into different baked product types influences glycemic response and satiety.
Detailed description
The purpose of this study is to investigate how millet incorporation into different baked product types (i.e. an extruded snack versus a biscuit) influences glycemic response and satiety.
This project will examine the effect of millet, on glycemic response and satiety. To determine the effect of product matrix and processing methods, testing will be done using an extruded snack, porridge, a couscous-like product and a biscuit.
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
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 |
|---|---|---|
| Commercial white bread | Placebo comparator | Other: Commercial white breadAll product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes. |
| Millet based products (porridge etc.) | Experimental | Other: Millet based products (porridge etc.)All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes. |
| Corn based products (porridge etc.) | Active comparator | Other: Corn based products (porridge etc.)All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men, age 19-40, non-smoking
- Normal fasting plasma glucose (<5.6 mmol/L but not below 3.6 mmol/L)
- Normal glucose tolerance (evaluated by a 75 g oral glucose test, i.e. <7.8 mmol/L but not below 3.6 mmol/L)
- BMI ranging from 18.5 to 29.9 kg/m2
Key exclusion criteria (14 listed)
- Insulin resistance (IR) will be calculated from fasting glucose and insulin values using the Homeostasis Assessment Model 2 (HOMA2). A HOMA2-IR value of greater than 1.0 will be considered indicative of insulin resistance (Levy J.C. et al. 1998).
- Regular consumption of millet as defined by questionnaire at screening defined as more than 1x per week
- Smoking or use of recreational drugs
- Heavy alcohol use (defined as typically >14 drinks per week or >4 drinks on one occasion)
- Very low fibre consumption as assessed by 24 hour food diary and self-reported fruit/vegetable/whole grain servings.
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 |
|---|---|---|
| Commercial white bread | Other | Commercial white bread |
| Corn based products (porridge etc.) | Other | Corn based products (porridge etc.) |
| Millet based products (porridge etc.) | Other | Millet based products (porridge etc.) |
Primary outcome
Determination of glycemic index based on collection of capillary plasma glucose
Time frame: Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes
1 secondary outcome
Self reported ratings of satiety
Time frame: Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours
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 22 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercial white bread, Corn based products (porridge etc.) and Millet based products (porridge etc.) in people with Hyperglycemia and Lack of Satiety, run by University of Guelph at 1 site in Canada.
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 14 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 22 Jan 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 Canada. 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?
Determination of glycemic index based on collection of capillary plasma glucose (time frame: Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 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 22 Jan 2016.