NCT01005563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

1.7 years

First QC Date

October 30, 2009

Last Update Submit

March 19, 2014

Conditions

AppetiteMoodWeight Loss

Outcome Measures

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.

    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.

    14 weeks

Study Arms (2)

Arm 1: Beef/Pork

EXPERIMENTAL

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

Other: Beef/Pork

Arm 2: Soy/Legumes

EXPERIMENTAL

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

Other: Soy/Legumes

Interventions

Beef/PorkOTHER

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

Arm 1: Beef/Pork
Soy/LegumesOTHER

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

Arm 2: Soy/Legumes

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • 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.

    PMID: 26864362DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wayne Campbell, Ph.D.

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 20, 2014

Record last verified: 2014-03

Locations

US(2)