NCT02980952

Brief Summary

The aim is to assess the impact of physical inactivity on muscle amino acid balance and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding will modulate muscle amino acid balance and forearm glucose uptake.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

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

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

November 30, 2016

Last Update Submit

October 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle amino acid balance

    Forearm muscle amino acid balance

    3 hours

Secondary Outcomes (1)

  • Glucose uptake

    3 hours

Study Arms (2)

Energy-balanced diet

PLACEBO COMPARATOR

Forearm immobilization whilst consuming an energy-balanced diet

Other: Forearm immobilization

High-fat overfeeding

EXPERIMENTAL

Forearm immobilization whilst consuming a high-fat diet, 50% energy excess

Other: High-fat overfeedingOther: Forearm immobilization

Interventions

High-fat overfeeding
Energy-balanced dietHigh-fat overfeeding

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18 and 30

You may not qualify if:

  • Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes).
  • Any diagnosed cardiovascular disease or hypertension.
  • Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140 mmHg over two or more measurements and an average diastolic blood pressure of ≥90 mmHg over two or more measurements.)
  • Chronic use of any prescribed or over the counter pharmaceuticals.
  • Regular use of nutritional supplements (e.g. creatine, protein supplementation)
  • Metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws).
  • A personal or family history of thrombosis, epilepsy, seizures or schizophrenia.
  • Any previous motor disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Wall BT, Cruz AM, Otten B, Dunlop MV, Fulford J, Porter C, Abdelrahman DR, Stephens FB, Dirks ML. The Impact of Disuse and High-Fat Overfeeding on Forearm Muscle Amino Acid Metabolism in Humans. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa184. doi: 10.1210/clinem/dgaa184.

  • Dirks ML, Wall BT, Otten B, Cruz AM, Dunlop MV, Barker AR, Stephens FB. High-fat Overfeeding Does Not Exacerbate Rapid Changes in Forearm Glucose and Fatty Acid Balance During Immobilization. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz049. doi: 10.1210/clinem/dgz049.

Study Officials

  • Benjamin T Wall, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 2, 2016

Study Start

January 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share