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

NCT ID: NCT03863431

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-22

Study Completion Date

2021-06-30

Brief Summary

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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

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Conditions

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Insulin Resistance Type 2 Diabetes Glucose Metabolism Disorders Metabolic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

High-fat diet

Intervention Type OTHER

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 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.

Group Type ACTIVE_COMPARATOR

High-carbohydrate diet

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loughborough University

OTHER

Sponsor Role lead

Responsible Party

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Carl Hulston

Senior Lecturer Nutrition and Metabolism

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carl Hulston, PhD

Role: PRINCIPAL_INVESTIGATOR

Loughborough University

Locations

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School of Sport, Exercise and Health Sciences

Loughborough, Leicestershire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Carl Hulston, PhD

Role: CONTACT

+44 (0)1509 226449

Zachary Lockhead, MSc

Role: CONTACT

Facility Contacts

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Carl Hulston, PhD

Role: primary

Other Identifiers

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R18-P222

Identifier Type: -

Identifier Source: org_study_id

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