Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults
S28
1 other identifier
interventional
48
1 country
1
Brief Summary
. The purpose of this study is to examine the effects of eating a larger amount of dairy-based protein on risk factors for metabolic syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 21, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedNovember 4, 2015
November 1, 2015
2.7 years
September 21, 2012
November 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight loss
20 weeks
Study Arms (2)
High protein consumption
EXPERIMENTALIntervention, energy restriction. This arm has a dietary protein intake of 1.5g/kg/d
Normal protein consumption
PLACEBO COMPARATORIntervention, energy restriction. This arm has a dietary protein intake of .8g/kg/d
Interventions
Subjects consume 750 kcal/d of energy below their need
Eligibility Criteria
You may qualify if:
- BMI: 25-38 ,male or female; age 35-65 y; weight stable (± 3 kg) during last 3 months; no acute illness; not diabetic, pregnant or lactating; not currently (or within last 3 months) following an exercise or weight loss program; non-smoking; not taking BP medication; not lactose intolerant,
You may not qualify if:
- Subjects will be excluded if baseline protein intake is less than 0.6 or greater than 1.6 g•kg-1•d-1 Subjects will also be excluded if they have any chronic or acute condition which will increase risk of illness or injury during study participation as determined by our study physician such as high BP, high fasting glucose, metabolic syndrome, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Purdue University - Stone Hall 700 W State St
West Lafayette, Indiana, 47907, United States
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wayne W Campbell, Ph. D.
Purdue University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Wayne Campbell, Ph.D.
Study Record Dates
First Submitted
September 21, 2012
First Posted
September 25, 2012
Study Start
January 1, 2012
Primary Completion
September 1, 2014
Study Completion
January 1, 2015
Last Updated
November 4, 2015
Record last verified: 2015-11