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

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.

Study Overview

• Status: Completed
• Conditions: Diet Modification; Mood; Glucose, Low Blood; Glucose, High Blood
• Intervention / Treatment: Dietary supplement: Low Glycaemic Diet; Dietary supplement: High Glycaemic Diet

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High GI diet; This diet contained three meals, all with a high GI value. This was the High Glycaemic Diet intervention.	Dietary supplement: High Glycaemic Diet; This intervention consisted of three meals, all with a high GI value.
Experimental: Low GI diet; This diet contained three meals, all with a low GI value. This was the Low Glycaemic Diet intervention.	Dietary supplement: Low Glycaemic Diet; This intervention consisted of three low GI meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood (alertness, anxiety and contentment) measured by Bond & Lader (1974) Visual Analogue Scale	The Bond & Lader VAS provides participants with 16 lines measuring 100mm each. At the ends of each line are two words opposite in meaning. For example, 'alert' and 'drowsy'. A participants marks on the line closer to the word they currently feel. The score from each line is out of 0 to 100.	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.

Collaborators and Investigators

• Sponsor: Matthew Grout
• Investigators: Principal Investigator: Daniel J Lamport, PhD, University of Reading

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: diet; glucose; mood; glycaemic index
• Other Study ID Numbers: 2016-032-DL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No