NCT01986036

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

3 months

First QC Date

November 11, 2013

Last Update Submit

April 18, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Energy Intake

    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 Outcomes (4)

  • Subjective appetite sensations

    1 hr

  • Insulin concentrations

    1 hr

  • GLP-1 (7-36) concentrations

    1 hr

  • GIP concentration

    1 hr

Study Arms (4)

CONTROL

SHAM COMPARATOR

Control breakfast low in protein and calcium. Porridge-based breakfast.

Dietary Supplement: Porridge-based breakfast.

PROTEIN

ACTIVE COMPARATOR

High-protein breakfast.

Dietary Supplement: ProteinDietary Supplement: Porridge-based breakfast.

CALCIUM

ACTIVE COMPARATOR

High-calcium breakfast.

Dietary Supplement: CalciumDietary Supplement: Porridge-based breakfast.

PRO-CAL

EXPERIMENTAL

High-protein and calcium breakfast.

Dietary Supplement: ProteinDietary Supplement: CalciumDietary Supplement: Porridge-based breakfast.

Interventions

ProteinDIETARY_SUPPLEMENT

Milk-Protein

PRO-CALPROTEIN
CalciumDIETARY_SUPPLEMENT

Soluble calcium powder.

CALCIUMPRO-CAL
Porridge-based breakfast.DIETARY_SUPPLEMENT

Oats and water.

CALCIUMCONTROLPRO-CALPROTEIN

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or Female
  • BMI 18.5-29.9 kg/m2
  • Age: 18-40 years

You may not qualify if:

  • Smokers
  • Food allergies
  • Metabolic disorders (ie. type 2 diabetes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 20875183BACKGROUND

  • 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.

    PMID: 24195627BACKGROUND

  • 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.

    PMID: 23689561BACKGROUND

  • 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.

    PMID: 25733462DERIVED

MeSH Terms

Interventions

ProteinsCalcium

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Javier T Gonzalez, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 18, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2014

Study Completion

May 1, 2014

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

GB(1)