Back to resultsSkeletal Muscle Protein Metabolism and Insulin Sensitivity in Overweight Individuals: Effects of Meals With Various Fatty Acid Compositions
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Saturated fat
Placebo
Fish Oil
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Resistance
Eligibility Criteria
Inclusion Criteria:
- Male, healthy, overweight (BMI>27 kg/m2 and fat mass >30%) non-diabetic individuals.
Exclusion Criteria:
- Diabetes, smoking, cardiovascular disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control
Saturated Fat
Fish Oil
Arm Description
Chocolate 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.
Chocolate 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.
Chocolate 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.
Outcomes
Primary Outcome Measures
Change in muscle protein fractional synthetic rate
Measurement of FSR at baseline and post intervention
Secondary Outcome Measures
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
Whole body and skeletal muscle fat oxidation
D31palmitate plasma enrichment and incorporation into skeletal muscle lipids
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03146286
Brief Title
Skeletal Muscle Protein Metabolism and Insulin Sensitivity in Overweight Individuals: Effects of Meals With Various Fatty Acid Compositions
Official Title
Skeletal Muscle Protein Metabolism and Insulin Sensitivity in Overweight Individuals: Effects of Meals With Various Fatty Acid Compositions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
December 3, 2015 (Actual)
Study Completion Date
December 3, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Chocolate 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.
Arm Title
Saturated Fat
Arm Type
Experimental
Arm Description
Chocolate 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.
Arm Title
Fish Oil
Arm Type
Experimental
Arm Description
Chocolate 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Saturated fat
Intervention Description
Palm stearin
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Water
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil
Intervention Description
Fish Oil, Omega 3 PUFA
Primary Outcome Measure Information:
Title
Change in muscle protein fractional synthetic rate
Description
Measurement of FSR at baseline and post intervention
Time Frame
3 hours post protein drink
Secondary Outcome Measure Information:
Title
whole body postprandial insulin sensitivity
Description
Glucose and insulin area under the curves (AUC) in response to the milk protein and glucose ingestion will be measured
Time Frame
Baseline and every 15mins for 7 hours
Title
Whole body and skeletal muscle fat oxidation
Description
D31palmitate plasma enrichment and incorporation into skeletal muscle lipids
Time Frame
Baseline and every 15mins for 7 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male, healthy, overweight (BMI>27 kg/m2 and fat mass >30%) non-diabetic individuals.
Exclusion Criteria:
Diabetes, smoking, cardiovascular disease
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22338035
Citation
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.
Results Reference
background
PubMed Identifier
21831993
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.
Results Reference
background
PubMed Identifier
23454694
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.
Results Reference
background
PubMed Identifier
35764009
Citation
Wilhelmsen 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.
Results Reference
derived
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Skeletal Muscle Protein Metabolism and Insulin Sensitivity in Overweight Individuals: Effects of Meals With Various Fatty Acid Compositions
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