NCT03146286

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

May 5, 2017

Last Update Submit

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 COMPARATOR

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.

Dietary Supplement: Placebo

Saturated Fat

EXPERIMENTAL

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.

Dietary Supplement: Saturated fat

Fish Oil

EXPERIMENTAL

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.

Dietary Supplement: Fish Oil

Interventions

Saturated fatDIETARY_SUPPLEMENT

Palm stearin

Saturated Fat
PlaceboDIETARY_SUPPLEMENT

Water

Control
Fish OilDIETARY_SUPPLEMENT

Fish Oil, Omega 3 PUFA

Fish Oil

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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: 22338035BACKGROUND
  • 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.

    PMID: 21831993BACKGROUND
  • 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.

    PMID: 23454694BACKGROUND
  • 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.

MeSH Terms

Conditions

Insulin Resistance

Interventions

Fatty AcidsFish Oils

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LipidsOils

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