- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02980952
Amino Acid Balance During Physical Inactivity
October 23, 2018 updated by: University of Exeter
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim is to assess the impact of forearm cast immobilization on muscle amino acid balance and forearm glucose uptake.
In addition, we will evaluate how high-fat overfeeding during immobilization will modulate muscle amino acid balance and forearm glucose uptake.
Study Type
Interventional
Enrollment (Actual)
22
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
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- BMI between 18 and 30
Exclusion Criteria:
- 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.
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Energy-balanced diet
Forearm immobilization whilst consuming an energy-balanced diet
|
|
|
Experimental: High-fat overfeeding
Forearm immobilization whilst consuming a high-fat diet, 50% energy excess
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle amino acid balance
Time Frame: 3 hours
|
Forearm muscle amino acid balance
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucose uptake
Time Frame: 3 hours
|
Forearm glucose uptake
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin T Wall, PhD, University of Exeter
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
- 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 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)
January 1, 2017
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
November 30, 2016
First Submitted That Met QC Criteria
December 1, 2016
First Posted (Estimate)
December 2, 2016
Study Record Updates
Last Update Posted (Actual)
October 25, 2018
Last Update Submitted That Met QC Criteria
October 23, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 157758/03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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