NCT02482558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

5 months

First QC Date

January 30, 2015

Last Update Submit

June 23, 2015

Conditions

Healthy

Keywords

Glycaemic IndexNAFLDGlycogenLiverDiet

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Liver lipids

    7 days

Other Outcomes (3)

  • Blood glucose

    7 days

  • Satiety ratings

    7 days

  • Blood hormones

    7 days

Study Arms (2)

High GI diet

EXPERIMENTAL

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.

Other: High/Low Glycaemic index test breakfast

Low GI diet

EXPERIMENTAL

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.

Other: High/Low Glycaemic index test breakfast

Interventions

High/Low Glycaemic index test breakfastOTHER

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

High GI dietLow GI diet

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham

Nottingham, Nottinghamshire, NG7 2QX, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Penny Gowland, PhD

    School of Physics & Astronomy, University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Robin Spiller, MD

    School of Medicine, University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

June 26, 2015

Study Start

February 1, 2013

Primary Completion

July 1, 2013

Study Completion

December 1, 2014

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

GB(1)