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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03863431
• Other study ID #: R18-P222
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2019
• Est. completion date: June 2021

Study information

• Verified date: February 2021
• Source: Loughborough University
• Contact: Carl Hulston, PhD
• Phone: +44 (0)1509 226449
• Email: c.j.hulston[@]lboro.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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]).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Insulin Resistance
• Metabolic Disease
• Metabolic Diseases
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	School of Sport, Exercise and Health Sciences	Loughborough	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
Loughborough University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body Mass Index	Calculated from height and weight	Day 0, Day 7, Day 14
Secondary	Fasting plasma glucose concentration	Measured in fasting plasma sample by spectrophotometric assay	Day 0, Day 7, Day 14
Secondary	Fasting serum insulin concentration	Measured in fasting serum sample by ELISA	Day 0, Day 7, Day 14
Secondary	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
Secondary	Indirect calorimetry	Measured from expired gas samples	Day 0, Day 7, Day 14
Secondary	Subjective appetite ratings	Measured from visual analogue scale appetite questionnaires	Day 0, Day 7, Day 14