Skeletal Muscle Protein Metabolism and Insulin Sensitivity in Overweight Individuals: Effects of Meals With Various Fatty Acid Compositions
1 other identifier
interventional
8
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2015
CompletedFirst Submitted
Initial submission to the registry
May 5, 2017
CompletedFirst Posted
Study publicly available on registry
May 9, 2017
CompletedMay 21, 2019
May 1, 2019
4 months
May 5, 2017
May 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in muscle protein fractional synthetic rate
Measurement of FSR at baseline and post intervention
3 hours post protein drink
Secondary Outcomes (2)
whole body postprandial insulin sensitivity
Baseline and every 15mins for 7 hours
Whole body and skeletal muscle fat oxidation
Baseline and every 15mins for 7 hours
Study Arms (3)
Control
PLACEBO COMPARATORChocolate flavoured drink spiked with 15mg/kg \[2H31\]palmitate (D31palmitate) and singly-labelled water (H218O). 4 hours post test meal a bolus of milk protein (30 g), which has been intrinsically labelled with \[13C\]phenylalanine, along with 75 g of glucose in 250 ml of water will be given.
Saturated Fat
EXPERIMENTALChocolate flavoured drink spiked with 15mg/kg \[2H31\]palmitate (D31palmitate) and singly-labelled water (H218O) containing 0.7 g/kg bodyweight palm stearin. 4 hours post test meal a bolus of milk protein (30 g), which has been intrinsically labelled with \[13C\]phenylalanine, along with 75 g of glucose in 250 ml of water will be given.
Fish Oil
EXPERIMENTALChocolate flavoured drink spiked with 15mg/kg \[2H31\]palmitate (D31palmitate) and singly-labelled water (H218O) containing 0.45 g/kg bodyweight palm stearin and 0.25 g/kg bodyweight fish oil (n3PUFA). 4 hours post test meal a bolus of milk protein (30 g), which has been intrinsically labelled with \[13C\]phenylalanine, along with 75 g of glucose in 250 ml of water will be given.
Interventions
Eligibility Criteria
You may qualify if:
- Male, healthy, overweight (BMI\>27 kg/m2 and fat mass \>30%) non-diabetic individuals.
You may not qualify if:
- Diabetes, smoking, cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Jans A, Konings E, Goossens GH, Bouwman FG, Moors CC, Boekschoten MV, Afman LA, Muller 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.
PMID: 22338035BACKGROUNDNewens 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.
PMID: 21831993BACKGROUNDNowotny 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.
PMID: 23454694BACKGROUNDWilhelmsen A, Davies A, Mallinson J, Pabla P, Jones R, Palmer EA, Dunn WB, Moran GW, Stephens FB, Tsintzas K. Acute effects of prior dietary fat ingestion on postprandial metabolic responses to protein and carbohydrate co-ingestion in overweight and obese men: A randomised crossover trial. Clin Nutr. 2022 Aug;41(8):1623-1635. doi: 10.1016/j.clnu.2022.06.022. Epub 2022 Jun 16.
PMID: 35764009DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2017
First Posted
May 9, 2017
Study Start
August 1, 2015
Primary Completion
December 3, 2015
Study Completion
December 3, 2015
Last Updated
May 21, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share