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The Acute, Synergistic Effects of Protein and Calcium on Appetite and Energy Intake

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Javier Gonzalez, PhD, Northumbria University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01986036
First Posted: November 18, 2013
Last Update Posted: April 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Javier Gonzalez, PhD, Northumbria University
  Purpose

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.


Condition Intervention
Healthy Dietary Supplement: Protein Dietary Supplement: Calcium Dietary Supplement: Porridge-based breakfast.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Acute, Synergistic Effects of Protein and Calcium on Appetite and Energy Intake

Resource links provided by NLM:


Further study details as provided by Javier Gonzalez, PhD, Northumbria University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • Insulin concentrations [ Time Frame: 1 hr ]
    Plasma insulin concentrations will be determined at baseline and every 15 min following test-meal consumption.

  • 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.

  • 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.


Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: May 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: CONTROL
Control breakfast low in protein and calcium. Porridge-based breakfast.
Dietary Supplement: Porridge-based breakfast.
Oats and water.
Active Comparator: PROTEIN
High-protein breakfast.
Dietary Supplement: Protein
Milk-Protein
Dietary Supplement: Porridge-based breakfast.
Oats and water.
Active Comparator: CALCIUM
High-calcium breakfast.
Dietary Supplement: Calcium
Soluble calcium powder.
Dietary Supplement: Porridge-based breakfast.
Oats and water.
Experimental: PRO-CAL
High-protein and calcium breakfast.
Dietary Supplement: Protein
Milk-Protein
Dietary Supplement: Calcium
Soluble calcium powder.
Dietary Supplement: Porridge-based breakfast.
Oats and water.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986036


Locations
United Kingdom
Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Investigators
Principal Investigator: Javier T Gonzalez, PhD Northumbria University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Javier Gonzalez, PhD, Research Fellow, Northumbria University
ClinicalTrials.gov Identifier: NCT01986036     History of Changes
Other Study ID Numbers: 32AN4
First Submitted: November 11, 2013
First Posted: November 18, 2013
Last Update Posted: April 21, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs