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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03561363
Enrollment
18
Registered
2018-06-19
Start date
2014-08-31
Completion date
2016-06-30
Last updated
2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Sensitivity

Keywords

insulin sensitivity, high-fat diet

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.

Interventions

BEHAVIORALHigh-fat diet

The aim of the intervention is to evaluate whether insulin sensitivity and selected Health parameters is affected, when the intake of saturated fatty acids or polyunsaturated fatty acids are highly increased, even when subjects are in energy balance.

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
27 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in whole body and peripheral insulin sensitivityEach subject completes a hyperinsulinemic-euglycemic clamp at pre-intervention (week 0) and again after 6 weeks of intervention.This outcome will be evaluated with the hyperinsulinemic-euglycemic clamp, combined with the femoral arterio-venous balance technique

Secondary

MeasureTime frameDescription
Change in gut microbiota population number and diversityFaeces 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.Gut microbiota will be analyzed in faeces samples obtained from the subjects before and after the intervention (using 18s-RNA sequencing)

Other

MeasureTime frameDescription
Change in molecular adaptations in skeletal muscle and adipose tissue induced by saturated and polyunsaturated fatty acidsBiopsies 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.Skeletal muscle and subcutaneous adipose tissue biopsies are obtained from each subject. Specific molecular analyses (western blotting and real time-PCR) are applied to tissue samples to assess changes in relevant genes and proteins.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026