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

• ClinicalTrials.gov Identifier: NCT03344185
• Recruitment Status: Completed
• First Posted: November 17, 2017
• Last Update Posted: November 17, 2017
• Sponsor: Matthew Grout
• Information provided by (Responsible Party): Matthew Grout, University of Reading

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mood; Diet Modification; Glucose, Low Blood; Glucose, High Blood	Dietary Supplement: Low Glycaemic Diet; Dietary Supplement: High Glycaemic Diet	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: All participants took part in both diet conditions
• Masking: Single (Participant)
• Masking Description: Participants were not told which diet they were consuming each day.
• Primary Purpose: Basic Science
• Official Title: The Effect of Glycaemic Index Variation on Blood Glucose and Mood in Healthy Participants Across the Day
• Actual Study Start Date: July 2016
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: October 2016

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Change in Glycaemic profile across the day [ Time Frame: 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. ]
   Change in blood glucose concentrations (mmol/L)

Secondary Outcome Measures :

1. Mood (alertness, anxiety and contentment) measured by Bond & Lader (1974) Visual Analogue Scale [ Time Frame: 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. ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Sponsors and Collaborators

Matthew Grout

Investigators

• Principal Investigator: Daniel J Lamport, PhD; University of Reading

More Information

• Responsible Party: Matthew Grout, Doctoral Researcher, University of Reading
• ClinicalTrials.gov Identifier: NCT03344185
• Other Study ID Numbers: 2016-032-DL
• First Posted: November 17, 2017
• Last Update Posted: November 17, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthew Grout, University of Reading:

glycaemic index; mood; glucose; diet

Additional relevant MeSH terms:

Hyperglycemia; Hypoglycemia; Glucose Metabolism Disorders; Metabolic Diseases