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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03146286
Other study ID # SCA/OF/12/15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2015
Est. completion date December 3, 2015

Study information

Verified date May 2019
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study will investigate whether impairment in the action of insulin to promote the use of glucose in skeletal muscle (insulin resistance) as a result of oral ingestion of a liquid meal rich in saturated fat is linked to reduced ability of muscles to synthesise new protein in response to dietary protein intake, which ultimately may compromise maintenance of muscle size and quality of life and whether partially replacing saturated fat in the liquid meal with omega 3 polyunsaturated FA (n3PUFA) will ameliorate these negative effects.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date December 3, 2015
Est. primary completion date December 3, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria:

- Male, healthy, overweight (BMI>27 kg/m2 and fat mass >30%) non-diabetic individuals.

Exclusion Criteria:

- Diabetes, smoking, cardiovascular disease

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Saturated fat
Palm stearin
Placebo
Water
Fish Oil
Fish Oil, Omega 3 PUFA

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Nottingham

References & Publications (3)

Jans A, Konings E, Goossens GH, Bouwman FG, Moors CC, Boekschoten MV, Afman LA, Müller M, Mariman EC, Blaak EE. PUFAs acutely affect triacylglycerol-derived skeletal muscle fatty acid uptake and increase postprandial insulin sensitivity. Am J Clin Nutr. 2012 Apr;95(4):825-36. doi: 10.3945/ajcn.111.028787. Epub 2012 Feb 15. — View Citation

Newens KJ, Thompson AK, Jackson KG, Wright J, Williams CM. DHA-rich fish oil reverses the detrimental effects of saturated fatty acids on postprandial vascular reactivity. Am J Clin Nutr. 2011 Sep;94(3):742-8. doi: 10.3945/ajcn.110.009233. Epub 2011 Aug 10. — View Citation

Nowotny B, Zahiragic L, Krog D, Nowotny PJ, Herder C, Carstensen M, Yoshimura T, Szendroedi J, Phielix E, Schadewaldt P, Schloot NC, Shulman GI, Roden M. Mechanisms underlying the onset of oral lipid-induced skeletal muscle insulin resistance in humans. Diabetes. 2013 Jul;62(7):2240-8. doi: 10.2337/db12-1179. Epub 2013 Mar 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in muscle protein fractional synthetic rate Measurement of FSR at baseline and post intervention 3 hours post protein drink
Secondary whole body postprandial insulin sensitivity Glucose and insulin area under the curves (AUC) in response to the milk protein and glucose ingestion will be measured Baseline and every 15mins for 7 hours
Secondary Whole body and skeletal muscle fat oxidation D31palmitate plasma enrichment and incorporation into skeletal muscle lipids Baseline and every 15mins for 7 hours
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