Clinical trial NCT03561363: The Effect of 6 Weeks Saturated and Polyunsaturated High-Fat Diets on Insulin Sensitivity and Health Parameters
Official title: The Effect of 6 Weeks Saturated and Polyunsaturated High-Fat Diets on Insulin Sensitivity and Health Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Keywords: insulin sensitivity
high-fat diet
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 18
Sex: MALE
Minimum age (years): 27
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* healthy male subjects
* 27-45 years
* BMI 22-31
* maximal oxygen uptake \<48 ml/kg/min

Exclusion Criteria:

* smokers
* use of medication
* parents with type-2 diabetes

Primary outcomes:
measure: Change in whole body and peripheral insulin sensitivity
timeFrame: Each subject completes a hyperinsulinemic-euglycemic clamp at pre-intervention (week 0) and again after 6 weeks of intervention.
Secondary outcomes:
measure: Change in gut microbiota population number and diversity
timeFrame: Faeces samples are obtained from each subject at pre-intervention (week 0), and after the intervention (week 6). Analyses will be performed when the last faeces sample is obtained.
Other outcomes:
measure: Change in molecular adaptations in skeletal muscle and adipose tissue induced by saturated and polyunsaturated fatty acids
timeFrame: Biopsies are obtained at pre-intervention (week 0) and at week 6 after the intervention. Analyses will be performed when the last tissue biopsies are obtained.
Locations:
Study officials:
affiliation: Dept. of Nutrition, Exercise and Sports, University of Copenhagen
name: Bente Kiens, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vessby B, Uusitupa M, Hermansen K, Riccardi G, Rivellese AA, Tapsell LC, Nalsen C, Berglund L, Louheranta A, Rasmussen BM, Calvert GD, Maffetone A, Pedersen E, Gustafsson IB, Storlien LH; KANWU Study. Substituting dietary saturated for monounsaturated fat impairs insulin sensitivity in healthy men and women: The KANWU Study. Diabetologia. 2001 Mar;44(3):312-9. doi: 10.1007/s001250051620.