The Effect of Glycaemic Index Variation on Blood Glucose and Mood in Healthy Participants Across the Day

NCT ID: NCT03344185

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-10-31

Brief Summary

This study provided 24 healthy subjects with two diets that varied in their glycaemic index values. One condition was a low GI diet, whilst the other was a high GI diet. Glucose concentrations and mood were measured throughout each test day.

Detailed Description

Therefore, the aim of this study is to feed to participants meals which differing in their glycaemic index across the course of a day, and thus produce different glycaemic responses. The outcome variables will be blood glucose levels and subjective mood. The purpose of this study is to identify the appropriate times (according to glycaemic response) at which cognitive functioning should be tested. Importantly, this study is also the first step to characterizing glycaemic and cognitive profiles associated with food consumption over a whole day (breakfast, lunch, snack) rather than just one meal (e.g. breakfast), ranging from the most favourable (stable glucose regulation) to the least favourable (variability; many peaks and troughs).

Conditions

Mood; Diet Modification; Glucose, Low Blood; Glucose, High Blood

Keywords

glycaemic index; mood; glucose; diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Low GI diet

This diet contained three meals, all with a low GI value. This was the Low Glycaemic Diet intervention.

Group Type: EXPERIMENTAL

Low Glycaemic Diet

Intervention Type: DIETARY_SUPPLEMENT

This intervention consisted of three low GI meals.

High GI diet

This diet contained three meals, all with a high GI value. This was the High Glycaemic Diet intervention.

Group Type: EXPERIMENTAL

High Glycaemic Diet

Intervention Type: DIETARY_SUPPLEMENT

This intervention consisted of three meals, all with a high GI value.

Interventions

Low Glycaemic Diet

This intervention consisted of three low GI meals.

Intervention Type: DIETARY_SUPPLEMENT

High Glycaemic Diet

This intervention consisted of three meals, all with a high GI value.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Aged between 18 and 65 years of age.
• Willing to participate in the entire study (signed informed consent required)
• Subjects will be eligible for the study if male or female (not pregnant or lactating)

Exclusion Criteria

• Diabetic
• Smoker
• Have any food intolerances or allergies
• History of alcohol or drug misuse
• Diagnosed with any of the following:

• High blood cholesterol
• High blood pressure
• Thyroid disorder
• Heart problems, stroke or any vascular disease in the past 12 months
• Inflammatory diseases such as rheumatoid arthritis
• Bone related conditions, such as osteoporosis
• Renal, gastrointestinal, respiratory, liver disease or cancer
• You are presently taking part in another clinical trial or research study
• You are an elite athlete (very high intensity training more than 3 times a week)
• You are currently on a specific diet or taking any dietary supplements and are unwilling to cease during the testing period
• You are intending to regularly use medication which affects gastrointestinal motility

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Matthew Grout

OTHER

Sponsor Role: lead

Responsible Party

Matthew Grout

Doctoral Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniel J Lamport, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Other Identifiers

2016-032-DL

Identifier Type: -

Identifier Source: org_study_id