The Influence of Overfeeding Different Macronutrients on Whole-body Insulin Sensitivity

Not Applicable

• Conditions: Insulin Resistance; Metabolic Disease; Type 2 Diabetes; Glucose Metabolism Disorders

• Registration Number: NCT03863431
• Lead Sponsor: Loughborough University

Brief Summary

This study will investigate the effect of high-carbohydrate vs. high-fat overfeeding (130% of energy requirements) on whole body insulin sensitivity.

Following habitual diet, participants will be randomly allocated to either a high-carbohydrate or a high-fat diet intervention for 14-days. On days 0, 7 and 14 participants will undergo anthropometric and metabolic testing (primarily an oral glucose tolerance test \[OGTT\]).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-03-02
• Study First Posted: 2019-03-05
• Study Start: 2019-05-22
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 18-40 years
• BMI = 18.5-29.9 kg/m2
• Male or female
• Physically active (> 3 x 30 min moderate exercise per week)
• Non-smoker (including the use of vaporisers and e-cigarettes)
• Healthy (determined by the School's standard health questionnaire)
• No cardiometabolic or inflammatory illness

Exclusion Criteria

• Outside of age-range
• Outside BMI range
• Inactive (< 3 x 30 min moderate exercise per week)
• Smoker
• Taking medication
• History of cardiometabolic or inflammatory illness
• Vegetarian/ vegan (as the high-fat diet is based on animal fats)
• Other dietary restrictions which prevent consumption of the experimental diet
• Consumption of probiotics within last 3 months (these influence the gut microbiota)
• Participation in another clinical trial
• Those with known or suspected food intolerances, allergies or hypersensitivity
• Women who are known to be pregnant or who are intending to become pregnant over the course of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Whole-body insulin sensitivity index	The change between pre-, during and post- dietary interventions: Assessed on days 0, 7 and 14	Assessed by oral glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
Fasting plasma lipid profile (for example total and HDL cholesterol and TAG concentrations; all measured in mmol/L)	Day 0, Day 7, Day 14	Measured in fasting plasma sample by spectrophotometric assay
Indirect calorimetry	Day 0, Day 7, Day 14	Measured from expired gas samples
Body Mass Index	Day 0, Day 7, Day 14	Calculated from height and weight
Fasting plasma glucose concentration	Day 0, Day 7, Day 14	Measured in fasting plasma sample by spectrophotometric assay
Subjective appetite ratings	Day 0, Day 7, Day 14	Measured from visual analogue scale appetite questionnaires
Fasting serum insulin concentration	Day 0, Day 7, Day 14	Measured in fasting serum sample by ELISA

Trial Locations

Locations (1)

School of Sport, Exercise and Health Sciences; 🇬🇧 Loughborough, Leicestershire, United Kingdom