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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01986036
• Other study ID #: 32AN4
• Status: Active, not recruiting
• Phase: N/A
• First received: November 11, 2013
• Last updated: April 18, 2014
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: April 2014
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Protein
Milk-Protein
• Calcium
Soluble calcium powder.
• Porridge-based breakfast.
Oats and water.

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle upon Tyne	Tyne and Wear

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Subjective appetite sensations	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	No
Secondary	Insulin concentrations	Plasma insulin concentrations will be determined at baseline and every 15 min following test-meal consumption.	1 hr	No
Secondary	GLP-1 (7-36) concentrations	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	No
Secondary	GIP concentration	Plasma glucose-dependent insulinotropic peptide (GIP) concentrations will be determined at baseline and evert 15 min following test-meal consumption.	1 hr	No