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

Primary Purpose

Appetite, Mood, Weight Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Beef/Pork

Soy/Legumes

About this trial

This is an interventional prevention trial for Appetite

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Purdue University
Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1: Beef/Pork

Arm 2: Soy/Legumes

Arm Description

Participants consuming diet with beef/pork as predominate sources of protein

Participants consuming diet with soy/legumes as predominate sources of protein

Outcomes

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.

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.

Full Information

NCT ID

NCT01005563

First Posted

October 30, 2009

Last Updated

March 19, 2014

Sponsor

Purdue University

1. Study Identification

Unique Protocol Identification Number

NCT01005563

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Purdue University

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Appetite, Mood, Weight Loss

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Beef/Pork

Arm Type

Experimental

Arm Description

Participants consuming diet with beef/pork as predominate sources of protein

Arm Title

Arm 2: Soy/Legumes

Arm Type

Experimental

Arm Description

Participants consuming diet with soy/legumes as predominate sources of protein

Intervention Type

Other

Intervention Name(s)

Beef/Pork

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Soy/Legumes

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

14 weeks

Secondary Outcome Measure Information:

Title

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Purdue University

City

W Lafayette

State/Province

Indiana

ZIP/Postal Code

47907

Country

United States

Facility Name

Purdue University

City

West Lafayette

State/Province

Indiana

ZIP/Postal Code

47906

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26864362

Citation

Zhou J, Kim JE, Armstrong CL, Chen N, Campbell WW. Higher-protein diets improve indexes of sleep in energy-restricted overweight and obese adults: results from 2 randomized controlled trials. Am J Clin Nutr. 2016 Mar;103(3):766-74. doi: 10.3945/ajcn.115.124669. Epub 2016 Feb 10.

Results Reference

derived

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

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