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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Carbonate
Calcium, Dietary
Antacids
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014