- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01682343
Effect of High-calcium Intake on Appetite, Insulinemia and Incretins
September 10, 2012 updated by: Javier Gonzalez, Northumbria University
The purpose of this study is to investigate the appetite, insulin and incretin hormone responses to a high-calcium meal.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will be provided with control and high-calcium meals.
Insulin, appetite, glucagon-like peptide-1 and glucose-dependent insulinotropic peptide responses will be assessed, along with rates of substrate oxidation.
Study Type
Interventional
Enrollment (Actual)
10
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 on Wear
-
Newcastle upon Tyne, Tyne on 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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- recreationally active
- male
Exclusion Criteria:
- food intolerances/allergies
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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Breakfast consisting of milk-based porridge with a normal calcium content.
|
|
Experimental: High-Calcium
As control, but with a high-calcium content.
|
Milk-calcium supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective appetite ratings
Time Frame: 3 hour
|
Subjective ratings of appetite assessed by visual analogue scales.
|
3 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum insulin concentration
Time Frame: 2 hour
|
2 hour area under the curve for serum insulin following breakfast consumption
|
2 hour
|
Plasma glucose-dependent insulinotropic peptide concentration
Time Frame: 2 hour
|
2 hour area under the curve for plasma glucose-dependent insulinotropic peptide following breakfast consumption
|
2 hour
|
Plasma glucagon-like peptide-1 concentration
Time Frame: 2 hour
|
2 hour area under the curve for plasma glucagon-like peptide-1 following breakfast consumption
|
2 hour
|
Other 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Javier T Gonzalez, MRes, 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
May 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
September 6, 2012
First Submitted That Met QC Criteria
September 6, 2012
First Posted (Estimate)
September 10, 2012
Study Record Updates
Last Update Posted (Estimate)
September 11, 2012
Last Update Submitted That Met QC Criteria
September 10, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32AN2
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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