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

Loughborough University

Status: Unknown

Conditions: Glucose Metabolism Disorders; Insulin Resistance; Metabolic Disease; Type 2 Diabetes

Treatments: Other: High-carbohydrate diet; Other: High-fat diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03863431

R18-P222

Details and patient eligibility

About

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]).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

High-fat diet

Active Comparator group

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.

Treatment:

Other: High-fat diet

High-carbohydrate diet

Active Comparator group

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.

Treatment:

Other: High-carbohydrate diet