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Effect of a High Calcium Breakfast on Exercise Metabolism and Appetite

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Javier Gonzalez, Northumbria University
ClinicalTrials.gov Identifier:
NCT01358591
First received: May 20, 2011
Last updated: June 2, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to assess the effect of a high calcium breakfast on substrate metabolism during exercise and appetite throughout the day.


Condition Intervention
Exercise Fat Oxidation
 Dietary Supplement: High calcium milk
Dietary Supplement: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Total fat oxidised during 60 min of exercise (g). [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Assessed by indirect calorimetry


Secondary Outcome Measures:
  • Blood glucose concentration [ Time Frame: 2 hour ] [ Designated as safety issue: No ]
    2 h incremental area under the curve for blood glucose following breakfast consumption

  • Serum Insulin Concentration [ Time Frame: 2 hour ] [ Designated as safety issue: No ]
    2 h area under the curve for serum insulin following breakfast consumption

  • Subjective appetite ratings [ Time Frame: 3 hour ] [ Designated as safety issue: No ]
    Subjective ratings of appetite assessed by visual analogue scales.


Enrollment: 9
Study Start Date: May 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control Breakfast
Normal calcium breakfast.
 Dietary Supplement: Control
Regular Milk
Experimental: High calcium breakfast
High calcium breakfast.
 Dietary Supplement: High calcium milk
High calcium milk (9 mg/kgBM)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • Aged 18-45 years
  • Physically active - able to run continuously for 1 h.

Exclusion Criteria:

  • Smokers
  • Food Allergies
  • Metabolic Disorders
  • Consuming herbal/dietary supplements
  • Gastric Problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358591

Locations
United Kingdom
Northumbria University
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
  More Information

No publications provided

Responsible Party: Javier Gonzalez, PhD Student, Northumbria University
ClinicalTrials.gov Identifier: NCT01358591     History of Changes
Other Study ID Numbers: 32AN1
Study First Received: May 20, 2011
Last Updated: June 2, 2012
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Calcium, Dietary
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013