The Effect of 6 Weeks Saturated & Polyunsaturated High-Fat Diets on

Status Completed

Clinical Trial Summary

The aim of the intervention is to gain insight into the long term effect of dietary fatty acid quality on insulin sensitivity and health parameters in healthy men.

Whole body and peripheral insulin sensitivity were measured, together with analyses of plasma hormones and metabolites. The plasma proteome was also analyzed. Molecular adaptations in skeletal muscle and adipose tissue were subject for investigation. Furthermore, gut microbiota population number and diversity will be analyzed from faeces samples obtained before and after the intervention.

Clinical Trial Description

Two experimental diets with a high fat content (65 E% fat), enriched in either saturated or polyunsaturated fatty acids, were provided for 6 weeks to healthy men, in a randomized controlled intervention study with two arms.

Healthy, untrained, non-obese male subjects (27-45 years) were included in the study. The experimental diets are eucaloric, and thus provided so the subjects remains weight stable.

Before and after the intervention, two experimental days was conducted (2 experiments before and 2 experiments after the intervention).

At pre-intervention, subjects completed a high-fat meal test and insulin sensitivity was measured by the hyperinsulinemic-euglycemic clamp. On both days, blood and tissue biopsies were obtained. These two experimental days were repeated at the end of the 6 weeks intervention.

The hyperinsulinemic-euglycemic clamp was combined with stable isotope infusion (deuterium labelled glucose) in order to measure hepatic glucose production. Before the clamp, a catheter is inserted into the femoral vein, to enable measurement of insulin stimulated glucose uptake across the leg. Biopsies are obtained by the needle biopsy method from the vastus lateralis muscle and peri-umbilical subcutaneous adipose tissue. Blood samples were analyzed for glucose, insulin, inflammatory markers, gut hormones, adipokines, plasma fatty acid composition, and lipoprotein profile. Indirect calorimetric was also applied to measure substrate oxidation during the experimental days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03561363
Study type	Interventional
Source	University of Copenhagen
Contact
Status	Completed
Phase	N/A
Start date	August 2014
Completion date	June 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effect of 6 Weeks Saturated and Polyunsaturated High-Fat Diets on Insulin Sensitivity and Health Parameters

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms