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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482558
• Other study ID #: UoN-URDC GI trial
• Status: Completed
• Phase: N/A
• First received: January 30, 2015
• Last updated: June 23, 2015
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• High/Low Glycaemic index test breakfast
High/Low Glycaemic index test breakfast on test days for a High/Low Glycaemic index 7-day diet

Locations

Country	Name	City	State
United Kingdom	Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Biotechnology and Biological Sciences Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood glucose	Subjects were cannulated at the start of the test day by research nurses and samples taken regularly for blood glucose. Blood glucose levels were measured approximately every 20 minutes for the first 3 hours of the feeding trial, and then hourly after up to 5 hours. 0.1 ml samples were drawn into plastic fluoride/oxalate glucose preservation tubes and were assessed at the University of Nottingham.	7 days	No
Other	Satiety ratings	During the experiment subjects filled out satiety questionnaires using Visual Analogue Scales (VAS) by answering each of five mixed appetite questions - "1. How hungry do you feel", "2. How satisfied do you feel", "3. How full do you feel?", "4. How strong is your desire to eat" and "5. How much do you think you can eat?". Subjects indicated their response by making a vertical mark on a horizontal scale between 1 and 10 every 20 minutes throughout the test day, and also before and after breakfast, lunch and dinner on days 1, 4 and 7 of the diet week.	7 days	No
Other	Blood hormones	Subjects were cannulated at the start of the test day by research nurses and samples taken regularly for blood hormones. Blood hormone levels were measured every 20 minutes for the first 3 hours, and then hourly after up to 5 hours. 0.5 ml samples for analysis of hormone levels were drawn into Becton-Dickinson P800 tubes and were analyzed at Unilever R&D Colworth using multiplex assay kits from Millipore. The hormones assayed were Amylin, CCK, Ghrelin, Glucagon, GLP-1, GIP, Insulin, Leptin, PP and PYY.	7 days	No
Primary	Liver glycogen	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.	7 days	No
Secondary	Liver lipids	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.	7 days	No