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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03863431
Enrollment
20
Registered
2019-03-05
Start date
2019-05-22
Completion date
2021-06-30
Last updated
2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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 \[OGTT\]).

Interventions

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.

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.

Sponsors

Loughborough University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Whole-body insulin sensitivity indexThe change between pre-, during and post- dietary interventions: Assessed on days 0, 7 and 14Assessed by oral glucose tolerance test

Secondary

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

Countries

United Kingdom

Contacts

Primary ContactCarl Hulston, PhD
c.j.hulston@lboro.ac.uk+44 (0)1509 226449
Backup ContactZachary Lockhead, MSc
Z.Lockhead@Lboro.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026