HealthyNCT04599738
Millet-based Muffins, Glycaemic Response, Insulinemic Response and Gastric Emptying
A study testing Wheat muffin and Finger millet grain muffin in people with Healthy and Pre Diabetes, run by Oxford Brookes University at 1 site in United Kingdom.
Trial summary
Millet is a functional grain that has attracted the attention of scientists for many years due to its significant benefits to human health. Research has shown that millets have a high antioxidant capacity and polyphenol content which can contribute to a reduced risk of some chronic diseases such as type 2 diabetes and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pre Diabetes
- What is being tested?
- Wheat muffin and Finger millet grain muffin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2017to 24 Dec 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- for healthy participants
- Aged 18-65 years
- Body mass index (BMI) ≤ 30kg/m2
- Fasting blood glucose < 6.1 mmol/l
- Non-pregnant and non-lactating
- No known diabetes or impaired glucose tolerance
Show all 11Show fewer
- No medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients
- No major medical or surgical event requiring hospitalisation within the preceding three months
- No use of steroids, protease inhibitors or antipsychotics
- No food allergy to millet, wheat, egg and milk.
- At least one of the following for pre-diabetes participants Fasting blood glucose 6.1-6.9 mmol/l (108-125 mg/ dI) - (WHO, 2006) or/and an Oral glucose tolerance test (OGTT) at 2 hours 7.9 to 11.0 mmol/l
Who cannot join
- • Pregnant and lactating
- Diabetes
- Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients
- Medical or surgical event requiring hospitalisation within the preceding three months
- Use of steroids, protease inhibitors or antipsychotics (because of their effects on glucose regulation of appetite or influence digestion and absorption of nutrients).
- Food allergy to study products (millet. wheat, egg, milk, butter, sugar).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Brookes Centre for Nutrition and Health
Oxford, OX3 0BP
About this study
Official title: The Effect of Millet-based Muffins on Glycaemic, Insulinemic Response and Gastric Emptying in Pre-diabetic Adults
Millet is a functional grain that has attracted the attention of scientists for many years due to its significant benefits to human health. Research has shown that millets have a high antioxidant capacity and polyphenol content which can contribute to a reduced risk of some chronic diseases such as type 2 diabetes and its complications. This study aimed to assess the glycaemic response (GR), insulinaemic response (IR) and gastric emptying (GE) after the consumption of millet-based muffins in pre-diabetic and healthy participants.
This was a single-blind, randomized controlled crossover study in which participants consumed one control muffin (wheat) and one test muffin (millet). During each session, participants were required to consume either the test or the control muffin, consuming the alternative on the next visit. Then, 10 finger-prick blood samples were taken for the determination of glucose and insulin over 4 hours. 13Carbon (13C) sodium acetate was added to the muffins (control and test) in order to measure gastric emptying from the breath samples collected.
Read the detailed description
This study aimed to assess the glycaemic response (GR), insulinaemic response (IR) and gastric emptying (GE) after the consumption of millet-based muffins in pre-diabetic and healthy participants. This was a single-blind, randomized controlled crossover study in which participants consumed one control muffin (wheat) and one test muffin (millet).This study investigated the effect of polyphenol-rich millet-based muffin on glycaemic response (GR), insulinaemic response (IR) and gastric emptying (GE) in healthy and pre-diabetic participants (people with prediabetes have blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes - the normal fasting blood glucose level is below 6.1 mmol/l or 108 mg/dl).
After potential participants have read the Participant Information Sheet (PIS) and signed the consent form, they were screened during the first visit to measure fasting blood glucose (FBG; fasting blood glucose should be between 6.1 to 6.9 mmol/l for pre-diabetic participants and < 6.1 mmol/l for healthy participants ).If eligible for the study, body weight and height and blood pressure were taken in the Functional Food Centre (currently known as Oxford Brookes Centre for Nutrition and Health). If the fasting blood glucose test was less than 6.1mmol/l (participants were informed of their fasting blood glucose result and given the choice either to do Oral glucose tolerance test (OGTT) to check for Impaired Glucose Tolerance (IGT), participate in the healthy group or to be excluded). If the participant agreed to continue and had one or more of the pre-diabetes inclusion criteria, they could complete an oral glucose tolerance test (OGTT) over 2 hours.( An oral glucose tolerance test involves taking a fasting sample of blood and then taking a very sweet drink containing 75g of glucose. After having this drink participants had to stay at rest until a further blood sample is taken after 2 hours.) If their 2 h blood glucose result was between 7.9 to 11.0 mmol/l, they were considered eligible to participate in the study as a prediabetic participant, and were asked to come for a subsequent visit in order to begin the study. If the participant does not have IGT, they had the option to take part in the study as a healthy participant.
- Conditions
- Healthy, Pre Diabetes
- Being tested
- Wheat muffin, Finger millet grain muffin
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat muffinOther
Participants consumed a control muffin made of wheat flour.
Finger millet grain muffinOther
Participants consumed a test muffin made of finger millet grain and wheat flour.
| Study group | Role | What they receive |
|---|---|---|
| Wheat muffin | Placebo comparator | Muffin made with 100% wheat flour Receives: Other: Wheat muffin |
| Finger millet grain muffin | Experimental | Muffin made with 50% wheat flour and 50% finger millet crushed grain Receives: Other: Finger millet grain muffin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycaemic response from baseline for 180 minutes
Capillary blood glucose was measured for 180 minutes at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Measured: 180 minutes
Change in insulin response from baseline for 180 minutes
Capillary plasma insulin was measured for 180 minutes at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Measured: 180 minutes
Secondary outcomes (2)
Gastric emptying for 4 hours
Breath samples were taken at every 15 minutes for 4 hours
Measured: 4 hours
Satiety by visual analogue scale for 4 hours
Visual analogues scale. The rating of the scale was: 6 = extremely full and 0 = extremely hungry. Higher score meant a better outcome of increased satiety.
Measured: 4hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start6 Mar 2017
- Primary completion24 Dec 2017
- Study completion24 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Collaborators
- Taibah University
- Responsible party
- Principal investigator, Dr. Sangeetha Thondre, Oxford Brookes University
- Investigators
- Sangeetha Thondre, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599738
- Sponsor's protocol ID
- UREC 161061
- Status last verified
- Oct 2020
- First submitted
- 11 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Brouns F, Bjorck I, Frayn KN, Gibbs AL, Lang V, Slama G, Wolever TM. Glycaemic index methodology. Nutr Res Rev. 2005 Jun;18(1):145-71. doi: 10.1079/NRR2005100.
PubMed 19079901Carbohydrates in human nutrition. Report of a Joint FAO/WHO Expert Consultation. FAO Food Nutr Pap. 1998;66:1-140. No abstract available.
PubMed 9743703
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Millet-based Muffins on Glycaemic, Insulinemic Response and Gastric Emptying in Pre-diabetic Adults
- ClinicalTrials.gov ID
- NCT04599738
- Acronym / sponsor ID
- UREC 161061
- Conditions
- Healthy, Pre Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Collaborators
- Taibah University
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 24 Dec 2017 (actual)
- Study completion
- 24 Dec 2017 (actual)
- First posted
- 23 Oct 2020 (actual)
- 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.
Millet is a functional grain that has attracted the attention of scientists for many years due to its significant benefits to human health. Research has shown that millets have a high antioxidant capacity and polyphenol content which can contribute to a reduced risk of some chronic diseases such as type 2 diabetes and its complications. This study aimed to assess the glycaemic response (GR), insulinaemic response (IR) and gastric emptying (GE) after the consumption of millet-based muffins in pre-diabetic and healthy participants.
This was a single-blind, randomized controlled crossover study in which participants consumed one control muffin (wheat) and one test muffin (millet). During each session, participants were required to consume either the test or the control muffin, consuming the alternative on the next visit. Then, 10 finger-prick blood samples were taken for the determination of glucose and insulin over 4 hours. 13Carbon (13C) sodium acetate was added to the muffins (control and test) in order to measure gastric emptying from the breath samples collected.
Detailed description
This study aimed to assess the glycaemic response (GR), insulinaemic response (IR) and gastric emptying (GE) after the consumption of millet-based muffins in pre-diabetic and healthy participants. This was a single-blind, randomized controlled crossover study in which participants consumed one control muffin (wheat) and one test muffin (millet).This study investigated the effect of polyphenol-rich millet-based muffin on glycaemic response (GR), insulinaemic response (IR) and gastric emptying (GE) in healthy and pre-diabetic participants (people with prediabetes have blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes - the normal fasting blood glucose level is below 6.1 mmol/l or 108 mg/dl).
After potential participants have read the Participant Information Sheet (PIS) and signed the consent form, they were screened during the first visit to measure fasting blood glucose (FBG; fasting blood glucose should be between 6.1 to 6.9 mmol/l for pre-diabetic participants and < 6.1 mmol/l for healthy participants ).If eligible for the study, body weight and height and blood pressure were taken in the Functional Food Centre (currently known as Oxford Brookes Centre for Nutrition and Health). If the fasting blood glucose test was less than 6.1mmol/l (participants were informed of their fasting blood glucose result and given the choice either to do Oral glucose tolerance test (OGTT) to check for Impaired Glucose Tolerance (IGT), participate in the healthy group or to be excluded). If the participant agreed to continue and had one or more of the pre-diabetes inclusion criteria, they could complete an oral glucose tolerance test (OGTT) over 2 hours.( An oral glucose tolerance test involves taking a fasting sample of blood and then taking a very sweet drink containing 75g of glucose. After having this drink participants had to stay at rest until a further blood sample is taken after 2 hours.) If their 2 h blood glucose result was between 7.9 to 11.0 mmol/l, they were considered eligible to participate in the study as a prediabetic participant, and were asked to come for a subsequent visit in order to begin the study. If the participant does not have IGT, they had the option to take part in the study as a healthy participant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheat muffin | Placebo comparator | Other: Wheat muffinMuffin made with 100% wheat flour |
| Finger millet grain muffin | Experimental | Other: Finger millet grain muffinMuffin made with 50% wheat flour and 50% finger millet crushed grain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- for healthy participants
- At least one of the following for pre-diabetes participants Fasting blood glucose 6.1-6.9 mmol/l (108-125 mg/ dI) - (WHO, 2006) or/and an Oral glucose tolerance test (OGTT) at 2 hours 7.9 to 11.0 mmol/l
Key exclusion criteria (6 listed)
- • Pregnant and lactating
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 |
|---|---|---|
| Wheat muffinParticipants consumed a control muffin made of wheat flour. | Other | Wheat muffin |
| Finger millet grain muffinParticipants consumed a test muffin made of finger millet grain and wheat flour. | Other | Finger millet grain muffin |
Primary outcome
Change in glycaemic response from baseline for 180 minutes
Time frame: 180 minutes
Capillary blood glucose was measured for 180 minutes at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Change in insulin response from baseline for 180 minutes
Time frame: 180 minutes
Capillary plasma insulin was measured for 180 minutes at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
2 secondary outcomes
Gastric emptying for 4 hours
Time frame: 4 hours
Satiety by visual analogue scale for 4 hours
Time frame: 4hours
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 Oct 2020.
- Background: PubMed 19079901Brouns F, Bjorck I, Frayn KN, Gibbs AL, Lang V, Slama G, Wolever TM. Glycaemic index methodology. Nutr Res Rev. 2005 Jun;18(1):145-71. doi: 10.1079/NRR2005100.
- Background: PubMed 9743703Carbohydrates in human nutrition. Report of a Joint FAO/WHO Expert Consultation. FAO Food Nutr Pap. 1998;66:1-140. No abstract available.
- Food Products-Determination of the glycaemic index (GI) and recommendation for food classification.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Sangeetha Thondre principal investigator
Oxford Brookes University
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 muffin and Finger millet grain muffin in people with Healthy and Pre Diabetes, run by Oxford Brookes University 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 11 inclusion and 6 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 Oct 2020. 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?
Change in glycaemic response from baseline for 180 minutes (time frame: 180 minutes). The study lists 2 primary outcomes in all. 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 NCT04599738, which also lists 2 linked publications.
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 Oct 2020.