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

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]).

Study Overview

• Status: Unknown
• Conditions: Glucose Metabolism Disorders; Insulin Resistance; Type 2 Diabetes; Metabolic Disease
• Intervention / Treatment: Other: High-fat diet; Other: High-carbohydrate diet

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicestershire
    • Loughborough, Leicestershire, United Kingdom, LE11 3TU
      • Recruiting
      • School of Sport, Exercise and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: High-fat diet; Participants will consume a diet rich in fat (approximately 65% of total energy) and low in carbohydrate for 14 days. Measurements will be made at 0, 7 and 14 days.	Other: High-fat diet; Participants will consume a high fat diet for 14 days with approximately 65% of energy from fat. The diet will also provide an energy excess, at 130% of energy requirements. Participants will be provided with all of their meals and snacks throughout the study.
ACTIVE_COMPARATOR: High-carbohydrate diet; Participants will consume a diet rich in carbohydrate (approximately 70% of total energy) and low in fat for 14 days. Measurements will be made at 0, 7 and 14 days.	Other: High-carbohydrate diet; Participants will consume a high fat diet for 14 days with approximately 70% of energy from carbohydrate. The diet will also provide an energy excess, at 130% of energy requirements. Participants will be provided with all of their meals and snacks throughout the study.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Loughborough University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2019
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: March 2, 2019
• First Posted (ACTUAL): March 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Glycaemic control; High-fat diets; High-carbohydrate diets
• Additional Relevant MeSH Terms: Hyperinsulinism; Insulin Resistance; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: R18-P222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No