Skeletal Muscle Protein Metabolism and Insulin Sensitivity in Overweight Individuals: Effects of Meals With Various Fatty Acid Compositions

May 17, 2019 updated by: University of Nottingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes, smoking, cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
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
Water
Experimental: Saturated Fat
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
Palm stearin
Experimental: Fish Oil
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
Fish Oil, Omega 3 PUFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle protein fractional synthetic rate
Time Frame: 3 hours post protein drink
Measurement of FSR at baseline and post intervention
3 hours post protein drink

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
whole body postprandial insulin sensitivity
Time Frame: Baseline and every 15mins for 7 hours
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
Whole body and skeletal muscle fat oxidation
Time Frame: Baseline and every 15mins for 7 hours
D31palmitate plasma enrichment and incorporation into skeletal muscle lipids
Baseline and every 15mins for 7 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

December 3, 2015

Study Completion (Actual)

December 3, 2015

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 9, 2017

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCA/OF/12/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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