Investigating the Effects of a High GI Versus a Low GI Diet on Hepatic Metabolism and Satiety Levels in Healthy Subjects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: High/Low Glycaemic index test breakfast

• Registration Number: NCT02482558
• Lead Sponsor: Unilever R&D

Brief Summary

The aim of this study is to investigate the effect of a one week high versus low glycaemic index dietary intervention on hepatic glycogen and lipid levels and blood hormone levels in a two way cross overs study and to see if there is any correlation between this and satiety or appetite.

Detailed Description

8 Healthy subject will be scanned the start and end of a 7 day high versus low glycaemic in diet with a 4 week washout between arms. During scan days the hepatic glycogen response to a corresponding high versus low glycaemic index test meal will be measured using 13C Magnetic resonance spectroscopy (MRS) to explore any acute changes in metabolic response. Baseline liver lipid levels will be measured using 1H MRS to explore any long term changes in liver lipid levels.

Blood samples will also be obtained throughout the test day to measure for blood glucose, insulin and blood hormone response. Satiety surveys will also be taken throughout the test day and during the diet week.

The main hypothesis is that a one week calorie matched Glycaemic index varied diet will result in an altered response of liver glycogen levels acutely following a meal and also longer term hepatic liver lipid levels. A secondary hypothesis is that there will also be associated changes in blood sugar and hormone levels and that all these changes will have an effect on satiety levels in subjects.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-07
• Study Completion: 2014-12
• Study First Submitted: 2015-01-30
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-23
• Last Update Submitted: 2015-06-23
• Study First Posted: 2015-06-26
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Male
• Caucasian
• Self-reported non-athletic but healthy: not carrying out strenuous exercise (no high sweat, out of breath, high heart rate activities and less than 2 hours moderate exercise a week), moderate drinkers (less than 3 units a day), no smokers
• Routinely eating 3 meals a day
• Stable weight
• Age ≥ 18 and ≤ 35
• Body mass index (BMI - weight / squared height ) ≥ 20.0 and ≤ 27.0 kg/m2
• Suitable for MRI scanning (e.g., absence of metal implants, infusion pumps and pacemakers) as assessed by the attached MRI safety questionnaire.
• Suitable for blood samples and cannula insertion (e.g., no aversion to needles)
• Willing to follow both prescribed diet plans
• Not taking any concurrent medication

Exclusion Criteria

• No diabetics or other metabolic disorders (e.g. insulin resistance, thyroid dysfunction)
• No volunteers with liver disease
• No clotting disorders
• No Participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
• No use of any medically or self-prescribed diet from the moment of pre-study examination till the end of the study
• Taking prescription medication or any other drugs that may influence liver function or glucose and energy metabolism.
• Any allergy or food intolerance
• Unsuitable for MR scanning (i.e. have pacemakers and/or medical implants)
• The subject is an employee of Unilever or the site conducting the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low GI diet	High/Low Glycaemic index test breakfast	8 Healthy subjects will be assessed at the start and end of a 7 day low glycaemic in diet following the appropriate High/Low Glycaemic index test breakfast.
High GI diet	High/Low Glycaemic index test breakfast	8 Healthy subjects will be assessed at the start and end of a 7 day high glycaemic in diet following the appropriate High/Low Glycaemic index test breakfast.

Primary Outcome Measures

Name	Time	Method
Liver glycogen	7 days	Liver glycogen content was determined by Magnetic Resonance Spectroscopy using the distinct 13C signals from the glycogen polymer. The glycogen signal resonates at 101.4 ppm, and was calibrated using an external reference peak situated in the centre of the coil (175ppm) and quantified with reference to an ex vivo glycogen acquisition.

Secondary Outcome Measures

Name	Time	Method
Liver lipids	7 days	Liver lipid content was determined by Magnetic Resonance Spectroscopy using the distinct 1H signals from the fatty acid. The peak area of the main chain CH2 peak at 1.3ppm was calibrated using the water peak at 4.7ppm as an internal reference, corrected for T2 relaxation, and quantified using biological parameters.

Trial Locations

Locations (1)

Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom