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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005563
• Other study ID #: 0905008129
• Secondary ID: 0905008129
• Status: Completed
• Phase: N/A
• First received: October 30, 2009
• Last updated: March 19, 2014
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: March 2014
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Appetite
• Mood
• Weight Loss

Intervention

Other:
• Beef/Pork
Participants consuming diet containing 10, 20 or 30% dietary protein with beef/pork as the predominate sources of protein
• Soy/Legumes
Participants consuming diet containing 10, 20, or 30% dietary protein with soy/legumes as the predominate sources of protein.

Locations

Country	Name	City	State
United States	Purdue University	W Lafayette	Indiana
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		14 weeks	Yes
Secondary	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.		14 weeks	Yes