The Influence of Overfeeding Different Macronutrients on Whole-body Insulin Sensitivity
1 other identifier
interventional
20
1 country
1
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 \[OGTT\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 5, 2019
CompletedStudy Start
First participant enrolled
May 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 24, 2021
February 1, 2021
2 years
February 14, 2019
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Body Mass Index
Day 0, Day 7, Day 14
Fasting plasma glucose concentration
Day 0, Day 7, Day 14
Fasting serum insulin concentration
Day 0, Day 7, Day 14
Fasting plasma lipid profile (for example total and HDL cholesterol and TAG concentrations; all measured in mmol/L)
Day 0, Day 7, Day 14
Indirect calorimetry
Day 0, Day 7, Day 14
- +1 more secondary outcomes
Study Arms (2)
High-fat diet
ACTIVE COMPARATORParticipants 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.
High-carbohydrate diet
ACTIVE COMPARATORParticipants 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Sport, Exercise and Health Sciences
Loughborough, Leicestershire, LE11 3TU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl Hulston, PhD
Loughborough University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer Nutrition and Metabolism
Study Record Dates
First Submitted
February 14, 2019
First Posted
March 5, 2019
Study Start
May 22, 2019
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
February 24, 2021
Record last verified: 2021-02