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

NCT03561363 | Completed

• 1 other identifier: H-3-2012-129
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insulin Sensitivity

Keywords

insulin sensitivity; high-fat diet

Outcome Measures

Primary Outcomes (1)

• Change in whole body and peripheral insulin sensitivity

  This outcome will be evaluated with the hyperinsulinemic-euglycemic clamp, combined with the femoral arterio-venous balance technique

  Each subject completes a hyperinsulinemic-euglycemic clamp at pre-intervention (week 0) and again after 6 weeks of intervention.

Secondary Outcomes (1)

• Change in gut microbiota population number and diversity

  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 (1)

• Change in molecular adaptations in skeletal muscle and adipose tissue induced by saturated and polyunsaturated fatty acids

  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.

Study Arms (2)

Saturated high-fat diet

EXPERIMENTAL

In this intervention group, subjects ingest a saturated eucaloric high-fat diet (64 E%) with total fat content being similar to the polyunsaturated high-fat diet. The diet is enriched in saturated fat (36 E%). The main saturated fatty acids in the diet are primarily palmitic acid (C16:0) and stearic acid (C18:0). The main food sources are milk products, high-fat meat and vegetables. Carbohydrate comprise 20 E% and protein 15 E%.

Behavioral: High-fat diet

polyunsaturated high-fat diet

EXPERIMENTAL

In this intervention group, subjects ingest a polyunsaturated eucaloric high-fat diet (64 E%), with total fat content being similar to the saturated high-fat diet. The diet is enriched in polyunsaturated fat (32 E%). The main polyunsaturated fatty acids in the diet are primarily linoleic acid (C18:2 n-6) and alpha-linoleic acid (C18:3 n-3). The main food sources are vegetable oils, nuts and high-fat fish (e.g. salmon). Carbohydrate comprise 20 E% and protein 15 E%.

Behavioral: High-fat diet

Interventions

High-fat diet BEHAVIORAL

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.

Saturated high-fat diet; polyunsaturated high-fat diet

Eligibility Criteria

• Age: 27 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead

Related Publications (1)

• 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.

  PMID: 11317662 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

Diet, High-Fat

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Bente Kiens, Professor

  Dept. of Nutrition, Exercise and Sports, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PostDoc. and principal investigator

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: June 19, 2018
• Study Start: August 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 19, 2018

Record last verified: 2018-06