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Effect of High-calcium Intake on Appetite, Insulinemia and Incretins

Primary Purpose

Nutritional and Metabolic Diseases

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Calcium
Sponsored by
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nutritional and Metabolic Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • recreationally active
  • male

Exclusion Criteria:

  • food intolerances/allergies

Sites / Locations

  • Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

High-Calcium

Arm Description

Breakfast consisting of milk-based porridge with a normal calcium content.

As control, but with a high-calcium content.

Outcomes

Primary Outcome Measures

Subjective appetite ratings
Subjective ratings of appetite assessed by visual analogue scales.

Secondary Outcome Measures

Serum insulin concentration
2 hour area under the curve for serum insulin following breakfast consumption
Plasma glucose-dependent insulinotropic peptide concentration
2 hour area under the curve for plasma glucose-dependent insulinotropic peptide following breakfast consumption
Plasma glucagon-like peptide-1 concentration
2 hour area under the curve for plasma glucagon-like peptide-1 following breakfast consumption

Full Information

First Posted
September 6, 2012
Last Updated
September 10, 2012
Sponsor
Northumbria University
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1. Study Identification

Unique Protocol Identification Number
NCT01682343
Brief Title
Effect of High-calcium Intake on Appetite, Insulinemia and Incretins
Official Title
Effect of High-calcium Intake on Appetite, Insulinemia and Incretins
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the appetite, insulin and incretin hormone responses to a high-calcium meal.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional and Metabolic Diseases

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Breakfast consisting of milk-based porridge with a normal calcium content.
Arm Title
High-Calcium
Arm Type
Experimental
Arm Description
As control, but with a high-calcium content.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium
Intervention Description
Milk-calcium supplement
Primary Outcome Measure Information:
Title
Subjective appetite ratings
Description
Subjective ratings of appetite assessed by visual analogue scales.
Time Frame
3 hour
Secondary Outcome Measure Information:
Title
Serum insulin concentration
Description
2 hour area under the curve for serum insulin following breakfast consumption
Time Frame
2 hour
Title
Plasma glucose-dependent insulinotropic peptide concentration
Description
2 hour area under the curve for plasma glucose-dependent insulinotropic peptide following breakfast consumption
Time Frame
2 hour
Title
Plasma glucagon-like peptide-1 concentration
Description
2 hour area under the curve for plasma glucagon-like peptide-1 following breakfast consumption
Time Frame
2 hour
Other Pre-specified Outcome Measures:
Title
Total fat oxidised during 60 min of exercise (g)
Description
Assessed by indirect calorimetry
Time Frame
1 hour

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: recreationally active male Exclusion Criteria: food intolerances/allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier T Gonzalez, MRes
Organizational Affiliation
Northumbria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northumbria University
City
Newcastle upon Tyne
State/Province
Tyne on Wear
ZIP/Postal Code
NE1 8ST
Country
United Kingdom

12. IPD Sharing Statement

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