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OpenTrials
Completed

NCT Number: NCT01005563

Effects of Dietary Protein Intake From Beef/Pork and Soy/Legumes on Appetite, Mood, and Weight Loss

The primary aims of this study are to assess the effects of habitual dietary protein intakes across the acceptable macronutrient distribution range with lean beef/pork or soy/legumes as the predominate sources of protein on indices of daily appetite and mood, and on postprandial appetite, mood, energy expenditure, and glycemic responses during energy-restricted weight loss in overweight adults.

Completed

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University, West Lafayette, Indiana, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age range: 21 years and older
  • Body mass index between 27.0-36.9 kg/m2
  • Non-smoking (within the last 6 months)
  • Weight stable (< 3 kg (~7 lbs) weight gain or loss within last 3 months)
  • Energy need for weight maintenance 1950-2750 kcal/day
  • Not dietary restrained
  • Menstruating women not pregnant or lactating
  • Constant habitual activity patterns (within last 3 months)
  • No Acute Illness (or have chronic diseases known to influence protein or energy metabolism)
  • Non-diabetic
  • Clinically normal blood profiles (within 10% of clinical normalcy)
  • Non-hypertensive
  • Not taking medications known to influence appetite or metabolism
  • Willingness to eat study foods
  • Able to travel to testing facility

Exclusion criteria

  • Age: <21 years
  • Body mass index: outside of the 27.0-36.9 kg/m2 range
  • Smoker (currently or within the last 6 months)
  • Gained or lost > 3.0 kg (7 lbs) within the last 3 months
  • Energy need for weight maintenance < 1950 or > 2750 kcal/day
  • Dietary restrained (≥ 14 on Three Factor Eating Questionnaire)
  • Pregnant, lactating, or non-menstruating women
  • Clinically diagnosed as a diabetic, or with liver or kidney disease/dysfunction, or osteoporosis
  • Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
  • Hypertensive
  • Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
  • Allergies to eggs
  • Lactose intolerance
  • Unwillingness to eat study foods
  • Inability to travel to testing facility

Treatment and study plan

Beef/Pork

Other

Participants consuming diet containing 10, 20 or 30% dietary protein with beef/pork as the predominate sources of protein

Soy/Legumes

Other

Participants consuming diet containing 10, 20, or 30% dietary protein with soy/legumes as the predominate sources of protein.

Primary outcomes

  1. Increasing protein intake from lean beef/pork or soy/legumes sources will result in progressively decreased daily composite hunger and desire to eat, and increased fullness. The responses will not be different between groups of subjects.

    Time frame: 14 weeks

Secondary outcomes

  1. Increasing the protein content of a test will result in progressively more robust and sustained changes in postprandial appetite and energy expenditure and blunted glycemic response. The responses will not be different between the groups of participants.

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 2, 2009
Registry last updated
Mar 20, 2014

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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