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Millet-based Muffins, Glycaemic Response, Insulinemic Response and Gastric Emptying

Primary Purpose

Healthy, Pre Diabetes

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Wheat muffin
Finger millet grain muffin
Sponsored by
Oxford Brookes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • • 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).

Sites / Locations

  • Oxford Brookes Centre for Nutrition and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Wheat muffin

Finger millet grain muffin

Arm Description

Muffin made with 100% wheat flour

Muffin made with 50% wheat flour and 50% finger millet crushed grain

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Gastric emptying for 4 hours
Breath samples were taken at every 15 minutes for 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.

Full Information

First Posted
October 11, 2020
Last Updated
October 17, 2020
Sponsor
Oxford Brookes University
Collaborators
Taibah University
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1. Study Identification

Unique Protocol Identification Number
NCT04599738
Brief Title
Millet-based Muffins, Glycaemic Response, Insulinemic Response and Gastric Emptying
Official Title
The Effect of Millet-based Muffins on Glycaemic, Insulinemic Response and Gastric Emptying in Pre-diabetic Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
December 24, 2017 (Actual)
Study Completion Date
December 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford Brookes University
Collaborators
Taibah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Pre Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wheat muffin
Arm Type
Placebo Comparator
Arm Description
Muffin made with 100% wheat flour
Arm Title
Finger millet grain muffin
Arm Type
Experimental
Arm Description
Muffin made with 50% wheat flour and 50% finger millet crushed grain
Intervention Type
Other
Intervention Name(s)
Wheat muffin
Intervention Description
Participants consumed a control muffin made of wheat flour.
Intervention Type
Other
Intervention Name(s)
Finger millet grain muffin
Intervention Description
Participants consumed a test muffin made of finger millet grain and wheat flour.
Primary Outcome Measure Information:
Title
Change in glycaemic response from baseline for 180 minutes
Description
Capillary blood glucose was measured for 180 minutes at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Time Frame
180 minutes
Title
Change in insulin response from baseline for 180 minutes
Description
Capillary plasma insulin was measured for 180 minutes at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Time Frame
180 minutes
Secondary Outcome Measure Information:
Title
Gastric emptying for 4 hours
Description
Breath samples were taken at every 15 minutes for 4 hours
Time Frame
4 hours
Title
Satiety by visual analogue scale for 4 hours
Description
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.
Time Frame
4hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: • 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeetha Thondre
Organizational Affiliation
Oxford Brookes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Brookes Centre for Nutrition and Health
City
Oxford
ZIP/Postal Code
OX3 0BP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Immediately following registration
IPD Sharing Access Criteria
Upon request
Citations:
PubMed Identifier
19079901
Citation
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.
Results Reference
background
PubMed Identifier
9743703
Citation
Carbohydrates in human nutrition. Report of a Joint FAO/WHO Expert Consultation. FAO Food Nutr Pap. 1998;66:1-140. No abstract available.
Results Reference
background
Links:
URL
http://www.iso.org/standard/43633.html
Description
Food Products-Determination of the glycaemic index (GI) and recommendation for food classification.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://drive.google.com/drive/u/0/folders/1wsl_6XU0myZgcXtOjRaemk414v9qgDaz
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://drive.google.com/drive/u/0/folders/1wsl_6XU0myZgcXtOjRaemk414v9qgDaz

Learn more about this trial

Millet-based Muffins, Glycaemic Response, Insulinemic Response and Gastric Emptying

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