The Acute, Synergistic Effects of Protein and Calcium on Appetite and Energy Intake
April 18, 2014 updated by: Javier Gonzalez, PhD, Northumbria University
High-protein meals have previously been shown to acutely reduce appetite and energy intake. More recently, meals higher in calcium have also been shown to increase feelings of fullness, circulating insulin and intestinal peptide concentrations and reduce appetite sensations.
This study aims to assess whether calcium and protein act synergistically to acutely influence appetite and energy intake.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
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 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or Female
- BMI 18.5-29.9 kg/m2
- Age: 18-40 years
Exclusion Criteria:
- Smokers
- Food allergies
- Metabolic disorders (ie. type 2 diabetes)
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
Control breakfast low in protein and calcium.
Porridge-based breakfast.
|
Oats and water.
|
|
Active Comparator: PROTEIN
High-protein breakfast.
|
Oats and water.
Milk-Protein
|
|
Active Comparator: CALCIUM
High-calcium breakfast.
|
Oats and water.
Soluble calcium powder.
|
|
Experimental: PRO-CAL
High-protein and calcium breakfast.
|
Oats and water.
Milk-Protein
Soluble calcium powder.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy Intake
Time Frame: 60 min post test-meal
|
Energy intake will be assessed by ad libitum consumption of a homogenous pasta meal, 1 h after the test-meal.
|
60 min post test-meal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective appetite sensations
Time Frame: 1 hr
|
Subjective appetite sensations (hunger, satisfaction, prospective consumption and fullness) will be assessed by visual analogue scales at baseline, and every 15 min following test-meal consumption.
|
1 hr
|
|
Insulin concentrations
Time Frame: 1 hr
|
Plasma insulin concentrations will be determined at baseline and every 15 min following test-meal consumption.
|
1 hr
|
|
GLP-1 (7-36) concentrations
Time Frame: 1 hr
|
Plasma glucagon-like peptide-1 (GLP-1) (7-36) concentrations will be determined at baseline and every 15 min following consumption of the test meal.
|
1 hr
|
|
GIP concentration
Time Frame: 1 hr
|
Plasma glucose-dependent insulinotropic peptide (GIP) concentrations will be determined at baseline and evert 15 min following test-meal consumption.
|
1 hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Javier T Gonzalez, PhD, Northumbria University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Astbury NM, Stevenson EJ, Morris P, Taylor MA, Macdonald IA. Dose-response effect of a whey protein preload on within-day energy intake in lean subjects. Br J Nutr. 2010 Dec;104(12):1858-67. doi: 10.1017/S000711451000293X. Epub 2010 Sep 28.
- Gonzalez JT, Rumbold PL, Stevenson EJ. Appetite sensations and substrate metabolism at rest, during exercise, and recovery: impact of a high-calcium meal. Appl Physiol Nutr Metab. 2013 Dec;38(12):1260-7. doi: 10.1139/apnm-2013-0056. Epub 2013 Jun 18.
- Gonzalez JT, Stevenson EJ. Calcium co-ingestion augments postprandial glucose-dependent insulinotropic peptide(1-42), glucagon-like peptide-1 and insulin concentrations in humans. Eur J Nutr. 2014;53(2):375-85. doi: 10.1007/s00394-013-0532-8. Epub 2013 May 21.
- Gonzalez JT, Green BP, Brown MA, Rumbold PL, Turner LA, Stevenson EJ. Calcium ingestion suppresses appetite and produces acute overcompensation of energy intake independent of protein in healthy adults. J Nutr. 2015 Mar;145(3):476-82. doi: 10.3945/jn.114.205708. Epub 2015 Jan 14.
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
November 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Anticipated)
May 1, 2014
Study Registration Dates
First Submitted
November 11, 2013
First Submitted That Met QC Criteria
November 15, 2013
First Posted (Estimate)
November 18, 2013
Study Record Updates
Last Update Posted (Estimate)
April 21, 2014
Last Update Submitted That Met QC Criteria
April 18, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32AN4
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.