- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01779245
Effect of High-calcium Intake on Substrate Metabolism During Exercise
September 4, 2013 updated by: Javier Gonzalez, Northumbria University
The Impact of a Calcium Supplementation on Lipid Metabolism During Exercise.
A high-calcium intake can accelerate fat loss under energy-restricted diets.
Part of this may be due to a shift in substrate metabolism where there is an increase in the rate of fat oxidation.
However, whether high-calcium intake can influence substrate metabolism during exercise is not known.
Accordingly, we aim to investigate the effect of 2 weeks of high-calcium intake on substrate metabolism during exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne and Wear
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Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
- Northumbria University
-
-
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
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Physically active (moderate-vigorous exercise >3 time per week)
- Male
- 18-40 yrs of age
Exclusion Criteria:
- Smoker
- Known Food Allergies
- Metabolic 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: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
A chocolate milkshake with a normal calcium content will be consumed daily (235 kcal; 13 g protein; 42 g carbohydrate; 1 g fat, 400 mg calcium per serving).
|
|
|
Experimental: High-Calcium
A chocolate milkshake with a high calcium content will be consumed daily (235 kcal; 13 g protein; 42 g carbohydrate; 1 g fat, 1400 mg calcium per serving).
|
Milk-extracted calcium supplement will be used to modulate the calcium content of the milkshakes used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Substrate metabolism
Time Frame: 60 s samples every 3 min for 15 min
|
Substrate metabolism will be assessed by the respiratory exchange ratio (rate of carbon dioxide production/rate of oxygen consumption) from samples of expired gas collected during the first 15 minutes of an incremental cycling test.
|
60 s samples every 3 min for 15 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma non-esterified fatty acid concentrations
Time Frame: Every 3 min for 15 min
|
Non-esterified fatty acid concentrations will be determined from plasma samples collected during the first 15 minutes of an incremental cycling test to indicate fatty acid availability.
|
Every 3 min for 15 min
|
|
Plasma glycerol concentrations
Time Frame: Every 3 min for 15 min
|
Glycerol concentrations will be determined from plasma samples collected during the first 15 minutes of an incremental cycling test as a marker of lipolysis.
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Every 3 min for 15 min
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum parathyroid hormone concentration
Time Frame: Baseline (Pre-post 2 week supplementation)
|
Parathyroid hormone concentrations will be determined at rest before and after supplementation periods as a indicator of calcium status.
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Baseline (Pre-post 2 week supplementation)
|
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Plasma glucose-dependent insulinotropic peptide concentration
Time Frame: Baseline (Pre-post 2 week supplementation)
|
Glucose-dependent insulinotropic peptide concentrations will be determined at rest before and after supplementation periods as a potential mechanism of any changes in metabolism.
|
Baseline (Pre-post 2 week supplementation)
|
|
Plasma glucagon-like peptide-1 concentration
Time Frame: Baseline (Pre-post 2 week supplementation)
|
Glucagon-like peptide-1 concentrations will be determined at rest before and after supplementation periods as a potential mechanism of any changes in metabolism.
|
Baseline (Pre-post 2 week supplementation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emma J Stevenson, PhD, Northumbria University
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
October 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
January 28, 2013
First Submitted That Met QC Criteria
January 29, 2013
First Posted (Estimate)
January 30, 2013
Study Record Updates
Last Update Posted (Estimate)
September 6, 2013
Last Update Submitted That Met QC Criteria
September 4, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32AN3
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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