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Completed

NCT Number: NCT01646749

Effects of Beef Protein Consumption on Energy Intake

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, 6200 MD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Differences in protein content (En%) of meals

Dietary Supplement

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 names: All food items will be commercial available.

Primary outcomes

  1. Body weight change

    Time frame: 11 days

    Body weight will be measured on day 1, 6 and 12. Subsequently, the change in body weight over time will be calculated.

  2. Appetite profile

    Time frame: 12 consecutive days

    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.

  3. Energy intake

    Time frame: 12 consecutive days

    Total energy intake over 12 days will be determined for each subject by adding energy intake during meals to energy intake from snack consumption.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Registry information

Official study title

Effects of Beef Protein Consumption on Energy Intake - The Protein Leverage Hypothesis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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