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

  • United Kingdom
    • 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.
Dietary supplement: Porridge-based breakfast.
Oats and water.
Active Comparator: PROTEIN
High-protein breakfast.
Dietary supplement: Porridge-based breakfast.
Oats and water.
Dietary supplement: Protein
Milk-Protein
Active Comparator: CALCIUM
High-calcium breakfast.
Dietary supplement: Porridge-based breakfast.
Oats and water.
Dietary supplement: Calcium
Soluble calcium powder.
Experimental: PRO-CAL
High-protein and calcium breakfast.
Dietary supplement: Porridge-based breakfast.
Oats and water.
Dietary supplement: Protein
Milk-Protein
Dietary supplement: Calcium
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

Northumbria University

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

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.

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