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

NCT04599738 | Completed

• 1 other identifier: UREC 161061
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Pre Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

  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

  180 minutes

Secondary Outcomes (2)

• Gastric emptying for 4 hours

  4 hours

• Satiety by visual analogue scale for 4 hours

  4hours

Study Arms (2)

Wheat muffin

PLACEBO COMPARATOR

Muffin made with 100% wheat flour

Other: Wheat muffin

Finger millet grain muffin

EXPERIMENTAL

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

Other: Finger millet grain muffin

Interventions

Wheat muffin OTHER

Participants consumed a control muffin made of wheat flour.

Wheat muffin

Finger millet grain muffin OTHER

Participants consumed a test muffin made of finger millet grain and wheat flour.

Finger millet grain muffin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oxford Brookes University: lead
• Taibah University: collaborator

Study Sites (1)

Oxford Brookes Centre for Nutrition and Health

Oxford, OX3 0BP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 19079901 BACKGROUND

• Carbohydrates in human nutrition. Report of a Joint FAO/WHO Expert Consultation. FAO Food Nutr Pap. 1998;66:1-140. No abstract available.

  PMID: 9743703 BACKGROUND

Related Links

• Food Products-Determination of the glycaemic index (GI) and recommendation for food classification.

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sangeetha Thondre

  Oxford Brookes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 23, 2020
• Study Start: March 6, 2017
• Primary Completion: December 24, 2017
• Study Completion: December 24, 2017
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following registration
• Access Criteria: Upon request

Locations

GB (1)