Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT01005563
First received: October 30, 2009
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Appetite
Mood
Weight Loss
 Other: Beef/Pork
Other: Soy/Legumes

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Dietary Protein Intake From Beef/Pork and Soy/Legumes on Appetite, Mood, and Weight Loss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Purdue University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Beef/Pork
Participants consuming diet with beef/pork as predominate sources of protein
 Other: Beef/Pork
Participants consuming diet containing 10, 20 or 30% dietary protein with beef/pork as the predominate sources of protein
Experimental: Arm 2: Soy/Legumes
Participants consuming diet with soy/legumes as predominate sources of protein
 Other: Soy/Legumes
Participants consuming diet containing 10, 20, or 30% dietary protein with soy/legumes as the predominate sources of protein.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005563

Locations
United States, Indiana
Purdue University
W Lafayette, Indiana, United States, 47907
Purdue University
West Lafayette, Indiana, United States, 47906
Purdue University, Dept of Foods and Nutrition
West Lafayette, Indiana, United States, 47906
Sponsors and Collaborators
Purdue University
  More Information

No publications provided

Responsible Party: Wayne Campbell, Wayne Campbell, Ph.D., Purdue University
ClinicalTrials.gov Identifier: NCT01005563     History of Changes
Other Study ID Numbers: 0905008129, 0905008129
Study First Received: October 30, 2009
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013