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

NCT03344185 | Completed

• 1 other identifier: 2016-032-DL
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

glycaemic index; mood; glucose; diet

Outcome Measures

Primary Outcomes (1)

• Change in Glycaemic profile across the day

  Change in blood glucose concentrations (mmol/L)

  Assessed at 0 (baseline), 15, 30, 45, 60, 90, 120 mins after each meal. With 3 meals in a day this totaled 21 assessment point for each day, giving 42 assessment points to compare overall. Data will be reported for the duration of this 3 year PhD award.

Secondary Outcomes (1)

• Mood (alertness, anxiety and contentment) measured by Bond & Lader (1974) Visual Analogue Scale

  This was measured 6 times a day (every 90 minutes starting at 0 minutes/baseline), giving a total of 12 times. Each time last approximately 5 minutes, giving a total of 60 minutes overall. Data will be reported for the duration of this 3 year PhD award.

Study Arms (2)

Low GI diet

EXPERIMENTAL

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

Dietary Supplement: Low Glycaemic Diet

High GI diet

EXPERIMENTAL

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

Dietary Supplement: High Glycaemic Diet

Interventions

Low Glycaemic Diet DIETARY_SUPPLEMENT

This intervention consisted of three low GI meals.

Low GI diet

High Glycaemic Diet DIETARY_SUPPLEMENT

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

High GI diet

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Matthew Grout: lead

Study Officials

• Daniel J Lamport, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not told which diet they were consuming each day.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral Researcher

Model Details: All participants took part in both diet conditions

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share