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

Mood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344185
• Other study ID #: 2016-032-DL
• Status: Completed
• Phase: N/A
• First received: November 9, 2017
• Last updated: November 14, 2017
• Start date: July 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2017
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification
• Glucose, High Blood
• Glucose, Low Blood
• Hyperglycemia
• Hypoglycemia
• Mood

Intervention

Dietary Supplement:
• Low Glycaemic Diet
This intervention consisted of three low GI meals.
• High Glycaemic Diet
This intervention consisted of three meals, all with a high GI value.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Matthew Grout

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.