NCT03879187

Brief Summary

This study determined the effect of 7 days of high-fat overfeeding on whole-body glycaemic control, glucose kinetics, skeletal muscle insulin signalling, and markers of skeletal muscle microvascular function in 15 healthy young individuals.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable healthy

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

March 2, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

3.2 years

First QC Date

March 12, 2019

Last Update Submit

March 15, 2019

Conditions

Keywords

High-fat dietInsulinGlucoseMuscleeNOSIsotopes

Outcome Measures

Primary Outcomes (5)

  • Change in glucose concentration

    Venous blood samples were obtained the day before and the day after the 7 day high-fat diet. Glucose was reported as mmol/L.

    Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)

  • Change in insulin concentration

    Venous blood samples were obtained the day before and the day after the 7 day high-fat diet. Insulin was reported as pmol/L.

    Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)

  • Change in glucose kinetics (i.e., rate of appearance and disappearance) assessed using isotope tracers

    Glucose kinetics were assessed the day before and the day after the 7 day high-fat diet. Data expressed as umol/kg/min.

    Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)

  • Change in skeletal muscle insulin signalling

    AKT and AS160 phosphorylation was determined by Western blotting of skeletal muscle. Data are expressed as arbitrary units.

    Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)

  • Change in markers of microvascular function

    endothelial nitric oxide synthase was determined in terminal arterioles by quantitative immunofluorescence microscopy that was performed on sections of skeletal muscle tissue. Data presented as arbitrary units.

    Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)

Secondary Outcomes (1)

  • Change intramuscular triglyceride content

    Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)

Study Arms (1)

High-fat diet

EXPERIMENTAL

Participants underwent a 7 day high-fat, high-energy diet intervention with metabolic measurements before and after

Dietary Supplement: High-fat, high-energy diet

Interventions

High-fat, high-energy dietDIETARY_SUPPLEMENT

Participants consumed a diet that was high in fat and high in energy

High-fat diet

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 40 years
  • Physically active
  • Non-smoker
  • Not taking any medication known to interfere with the study
  • No history of cardiovascular disease or diabetes
  • Weight stable for the last 6 months

You may not qualify if:

  • Outside of age range
  • Sedentary
  • Smoker
  • Taking medication known to interfere with the study
  • History of cardiovascular disease or diabetes
  • Unstable weight within last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Parry SA, Turner MC, Woods RM, James LJ, Ferguson RA, Cocks M, Whytock KL, Strauss JA, Shepherd SO, Wagenmakers AJM, van Hall G, Hulston CJ. High-Fat Overfeeding Impairs Peripheral Glucose Metabolism and Muscle Microvascular eNOS Ser1177 Phosphorylation. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz018. doi: 10.1210/clinem/dgz018.

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 15 healthy individuals were assessed before and after consuming a high-fat, high-energy diet for 7 days.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer; Principal Investigator

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 18, 2019

Study Start

March 2, 2015

Primary Completion

May 22, 2018

Study Completion

May 22, 2018

Last Updated

March 18, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share