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

Primary Purpose

Insulin Resistance, Type 2 Diabetes, Glucose Metabolism Disorders

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

High-fat diet

High-carbohydrate diet

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring High-fat diets, High-carbohydrate diets, Glycaemic control

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

School of Sport, Exercise and Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

High-fat diet

High-carbohydrate diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Whole-body insulin sensitivity index

Assessed by oral glucose tolerance test

Secondary Outcome Measures

Body Mass Index

Calculated from height and weight

Fasting plasma glucose concentration

Measured in fasting plasma sample by spectrophotometric assay

Fasting serum insulin concentration

Measured in fasting serum sample by ELISA

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

Indirect calorimetry

Measured from expired gas samples

Subjective appetite ratings

Measured from visual analogue scale appetite questionnaires

Full Information

NCT ID

NCT03863431

First Posted

February 14, 2019

Last Updated

February 23, 2021

Sponsor

Loughborough University

1. Study Identification

Unique Protocol Identification Number

NCT03863431

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 22, 2019 (Actual)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Loughborough University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance, Type 2 Diabetes, Glucose Metabolism Disorders, Metabolic Disease

Keywords

High-fat diets, High-carbohydrate diets, Glycaemic control

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High-fat diet

Arm Type

Active Comparator

Arm Description

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.

Arm Title

High-carbohydrate diet

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

High-fat diet

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

High-carbohydrate diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

Whole-body insulin sensitivity index

Description

Assessed by oral glucose tolerance test

Time Frame

The change between pre-, during and post- dietary interventions: Assessed on days 0, 7 and 14

Secondary Outcome Measure Information:

Title

Body Mass Index

Description

Calculated from height and weight

Time Frame

Day 0, Day 7, Day 14

Title

Fasting plasma glucose concentration

Description

Measured in fasting plasma sample by spectrophotometric assay

Time Frame

Day 0, Day 7, Day 14

Title

Fasting serum insulin concentration

Description

Measured in fasting serum sample by ELISA

Time Frame

Day 0, Day 7, Day 14

Title

Fasting plasma lipid profile (for example total and HDL cholesterol and TAG concentrations; all measured in mmol/L)

Description

Measured in fasting plasma sample by spectrophotometric assay

Time Frame

Day 0, Day 7, Day 14

Title

Indirect calorimetry

Description

Measured from expired gas samples

Time Frame

Day 0, Day 7, Day 14

Title

Subjective appetite ratings

Description

Measured from visual analogue scale appetite questionnaires

Time Frame

Day 0, Day 7, Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carl Hulston, PhD

Phone

+44 (0)1509 226449

c.j.hulston@lboro.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Zachary Lockhead, MSc

Z.Lockhead@Lboro.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl Hulston, PhD

Organizational Affiliation

Loughborough University

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Sport, Exercise and Health Sciences

City

Loughborough

State/Province

Leicestershire

ZIP/Postal Code

LE11 3TU

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carl Hulston, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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