- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01358591
Effect of a High Calcium Breakfast on Exercise Metabolism and Appetite
June 2, 2012 updated by: Javier Gonzalez, Northumbria University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
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
-
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 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
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 |
|---|---|
|
Sham Comparator: Control Breakfast
Normal calcium breakfast.
|
Regular Milk
|
|
Experimental: High calcium breakfast
High calcium breakfast.
|
High calcium milk (9 mg/kgBM)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total fat oxidised during 60 min of exercise (g).
Time Frame: 1 hour
|
Assessed by indirect calorimetry
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose concentration
Time Frame: 2 hour
|
2 h incremental area under the curve for blood glucose following breakfast consumption
|
2 hour
|
|
Serum Insulin Concentration
Time Frame: 2 hour
|
2 h area under the curve for serum insulin following breakfast consumption
|
2 hour
|
|
Subjective appetite ratings
Time Frame: 3 hour
|
Subjective ratings of appetite assessed by visual analogue scales.
|
3 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
May 20, 2011
First Submitted That Met QC Criteria
May 20, 2011
First Posted (Estimate)
May 23, 2011
Study Record Updates
Last Update Posted (Estimate)
June 5, 2012
Last Update Submitted That Met QC Criteria
June 2, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32AN1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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