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Effect of High-calcium Intake on Substrate Metabolism During Exercise

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Javier Gonzalez, Northumbria University
ClinicalTrials.gov Identifier:
NCT01779245
First received: January 28, 2013
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Lipid Metabolism
 Dietary Supplement: Calcium
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Impact of a Calcium Supplementation on Lipid Metabolism During Exercise.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Substrate metabolism [ Time Frame: 60 s samples every 3 min for 15 min ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Plasma non-esterified fatty acid concentrations [ Time Frame: Every 3 min for 15 min ] [ Designated as safety issue: No ]
    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.

  • Plasma glycerol concentrations [ Time Frame: Every 3 min for 15 min ] [ Designated as safety issue: No ]
    Glycerol concentrations will be determined from plasma samples collected during the first 15 minutes of an incremental cycling test as a marker of lipolysis.


Other Outcome Measures:
  • Serum parathyroid hormone concentration [ Time Frame: Baseline (Pre-post 2 week supplementation) ] [ Designated as safety issue: No ]
    Parathyroid hormone concentrations will be determined at rest before and after supplementation periods as a indicator of calcium status.

  • Plasma glucose-dependent insulinotropic peptide concentration [ Time Frame: Baseline (Pre-post 2 week supplementation) ] [ Designated as safety issue: No ]
    Glucose-dependent insulinotropic peptide concentrations will be determined at rest before and after supplementation periods as a potential mechanism of any changes in metabolism.

  • Plasma glucagon-like peptide-1 concentration [ Time Frame: Baseline (Pre-post 2 week supplementation) ] [ Designated as safety issue: No ]
    Glucagon-like peptide-1 concentrations will be determined at rest before and after supplementation periods as a potential mechanism of any changes in metabolism.


Enrollment: 13
Study Start Date: October 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
 Dietary Supplement: Placebo
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).
 Dietary Supplement: Calcium
Milk-extracted calcium supplement will be used to modulate the calcium content of the milkshakes used.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779245

Locations
United Kingdom
Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Investigators
Principal Investigator: Emma J Stevenson, PhD Northumbria University
  More Information

No publications provided

Responsible Party: Javier Gonzalez, Principal Investigator, Northumbria University
ClinicalTrials.gov Identifier: NCT01779245     History of Changes
Other Study ID Numbers: 32AN3
Study First Received: January 28, 2013
Last Updated: January 29, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013