Clinical trial NCT01005563: 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
Overall status: COMPLETED
Phase: NA
Conditions: Appetite
Mood
Weight Loss
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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.
timeFrame: 14 weeks
Secondary outcomes:
measure: 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.
timeFrame: 14 weeks
Other outcomes:
Locations:
city: W Lafayette
country: United States
facility: Purdue University
state: Indiana
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
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.