Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults (S28)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT01692860
First received: September 21, 2012
Last updated: November 3, 2015
Last verified: November 2015

September 21, 2012
November 3, 2015
January 2012
September 2014   (final data collection date for primary outcome measure)
weight loss [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01692860 on ClinicalTrials.gov Archive Site
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Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults
Effects of Milk Protein Concentrate on Blood Pressure, Inflammation, Muscle Health During Weight Loss in Overweight/Obese Adults
. 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
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.
Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Sarcopenia
  • Metabolic Disease
  • High Blood Pressure
Other: Energy Restriction
Subjects consume 750 kcal/d of energy below their need
  • Experimental: High protein consumption
    Intervention, energy restriction. This arm has a dietary protein intake of 1.5g/kg/d
    Intervention: Other: Energy Restriction
  • Placebo Comparator: Normal protein consumption
    Intervention, energy restriction. This arm has a dietary protein intake of .8g/kg/d
    Intervention: Other: Energy Restriction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2015
September 2014   (final data collection date for primary outcome measure)

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.

Both
35 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01692860
1109011319
No
Not Provided
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Wayne Campbell, Purdue University
Purdue University
Not Provided
Principal Investigator: Wayne W Campbell, Ph. D. Purdue University
Purdue University
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP