Back to resultsEffects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults (S28)
Primary Purpose
Sarcopenia, Metabolic Disease, High Blood Pressure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Energy Restriction
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring the impact of a higher dairy-based protein diet in, combination with energy restriction on muscle health,, metabolic health (including blood pressure) in overweight, and obese, middle aged adults
Eligibility Criteria
Inclusion Criteria:
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,
Exclusion Criteria:
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.
Sites / Locations
- Purdue University - Stone Hall 700 W State St
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
High protein consumption
Normal protein consumption
Arm Description
Intervention, energy restriction. This arm has a dietary protein intake of 1.5g/kg/d
Intervention, energy restriction. This arm has a dietary protein intake of .8g/kg/d
Outcomes
Primary Outcome Measures
weight loss
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01692860
Brief Title
Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults
Acronym
S28
Official Title
Effects of Milk Protein Concentrate on Blood Pressure, Inflammation, Muscle Health During Weight Loss in Overweight/Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Currently, over 47 million adults in the United States are known to have metabolic syndrome. Metabolic syndrome is comprised of a cluster of conditions including obesity, elevated cholesterol, high blood sugar, and high blood pressure. People with metabolic syndrome have an increased risk for the development of chronic diseases such as cardiovascular disease and diabetes. Recent studies have shown that a build-up of fat in the muscle of overweight and obese people may partially explain the link between metabolic syndrome and the development of chronic diseases. There is evidence to suggest that diets with a higher amount of protein can improve some aspects of metabolic syndrome, including the build-up of fat in muscle. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Metabolic Disease, High Blood Pressure
Keywords
the impact of a higher dairy-based protein diet in, combination with energy restriction on muscle health,, metabolic health (including blood pressure) in overweight, and obese, middle aged adults
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High protein consumption
Arm Type
Experimental
Arm Description
Intervention, energy restriction. This arm has a dietary protein intake of 1.5g/kg/d
Arm Title
Normal protein consumption
Arm Type
Placebo Comparator
Arm Description
Intervention, energy restriction. This arm has a dietary protein intake of .8g/kg/d
Intervention Type
Other
Intervention Name(s)
Energy Restriction
Intervention Description
Subjects consume 750 kcal/d of energy below their need
Primary Outcome Measure Information:
Title
weight loss
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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,
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne W Campbell, Ph. D.
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University - Stone Hall 700 W State St
City
W Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
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
Learn more about this trial
Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults
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