Insulin Sensitivity Clinical Trial
Official title:
The Effect of 6 Weeks Saturated and Polyunsaturated High-Fat Diets on Insulin Sensitivity and Health Parameters
NCT number | NCT03561363 |
Other study ID # | H-3-2012-129 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | June 2016 |
Verified date | June 2018 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 27 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen |
Vessby B, Uusitupa M, Hermansen K, Riccardi G, Rivellese AA, Tapsell LC, Nälsén 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in molecular adaptations in skeletal muscle and adipose tissue induced by saturated and polyunsaturated fatty acids | 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. | 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. | |
Primary | 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 | Change in gut microbiota population number and diversity | Gut microbiota will be analyzed in faeces samples obtained from the subjects before and after the intervention (using 18s-RNA sequencing) | 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. |
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