Effects of Beef Protein Consumption on Energy Intake

This study has been completed.
Sponsor:
Collaborator:
National Cattlemen's Beef Association
Information provided by (Responsible Party):
Eveline Martens, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01646749
First received: July 16, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine ad libitum daily energy intake, body weight changes and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, body mass index (BMI) and fat mass and obesity-associated (FTO) gene alleles.


Condition Intervention
Obesity
Severe Overweight
Dietary Supplement: Differences in protein content (En%) of meals

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Beef Protein Consumption on Energy Intake - The Protein Leverage Hypothesis

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Body weight change [ Time Frame: 11 days ] [ Designated as safety issue: No ]
    Body weight will be measured on day 1, 6 and 12. Subsequently, the change in body weight over time will be calculated.

  • Appetite profile [ Time Frame: 12 consecutive days ] [ Designated as safety issue: No ]
    Appetite profile will be measured by means of questionnaires: visual analogue scales (VAS). Area under the curve (AUC) will be calculated over 12 consecutive days.

  • Energy intake [ Time Frame: 12 consecutive days ] [ Designated as safety issue: No ]
    Total energy intake over 12 days will be determined for each subject by adding energy intake during meals to energy intake from snack consumption.


Enrollment: 30
Study Start Date: September 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protein intake of 5 energy percent (En%) Dietary Supplement: Differences in protein content (En%) of meals
The three applied conditions will differ in the relative protein content of the meals, including 5 En%, 15 En% and 30 En% from protein. Beef protein will be used as main meat protein source in the 15 En% and 30 En% protein conditions. The resulting macronutrient compositions of the diets will be En% Protein/Carbohydrate/Fat; 5/60/35, 15/50/35, and 30/35/35. All meals (breakfast, lunch, dinner) within each condition will have the same macronutrient composition. All food items, and the energy density, weight and volume of the meals will be the same between conditions. All snack items will be very low in protein content.
Other Name: All food items will be commercial available.
Experimental: Protein intake of 15 En% Dietary Supplement: Differences in protein content (En%) of meals
The three applied conditions will differ in the relative protein content of the meals, including 5 En%, 15 En% and 30 En% from protein. Beef protein will be used as main meat protein source in the 15 En% and 30 En% protein conditions. The resulting macronutrient compositions of the diets will be En% Protein/Carbohydrate/Fat; 5/60/35, 15/50/35, and 30/35/35. All meals (breakfast, lunch, dinner) within each condition will have the same macronutrient composition. All food items, and the energy density, weight and volume of the meals will be the same between conditions. All snack items will be very low in protein content.
Other Name: All food items will be commercial available.
Experimental: Protein intake of 30 En% Dietary Supplement: Differences in protein content (En%) of meals
The three applied conditions will differ in the relative protein content of the meals, including 5 En%, 15 En% and 30 En% from protein. Beef protein will be used as main meat protein source in the 15 En% and 30 En% protein conditions. The resulting macronutrient compositions of the diets will be En% Protein/Carbohydrate/Fat; 5/60/35, 15/50/35, and 30/35/35. All meals (breakfast, lunch, dinner) within each condition will have the same macronutrient composition. All food items, and the energy density, weight and volume of the meals will be the same between conditions. All snack items will be very low in protein content.
Other Name: All food items will be commercial available.

Detailed Description:

The protein leverage hypothesis requires specific evidence whether energy intake would depend on a possible protein intake target in humans. Meat protein as complete protein may show most beneficial effects on variables regarding food intake regulation.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Age 18-70 years
  • BMI 18-35 kg/m2
  • Non-smoking
  • Weight stable

Exclusion Criteria:

  • Smoking
  • Use of medication
  • More than moderate alcohol consumption
  • Vegetarian
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646749

Locations
Netherlands
Maastricht University
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
National Cattlemen's Beef Association
Investigators
Principal Investigator: Margriet S Westerterp-Plantenga, Prof. dr. Maastricht University
  More Information

Publications:
Responsible Party: Eveline Martens, PhD student, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01646749     History of Changes
Other Study ID Numbers: NL41371
Study First Received: July 16, 2012
Last Updated: July 10, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
Energy intake
Beef protein
Satiety
Protein leverage hypothesis

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014