Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01692860
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

Tracking Information
First Submitted Date  ICMJE September 21, 2012
First Posted Date  ICMJE September 25, 2012
Last Update Posted Date November 4, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2013)
weight loss [ Time Frame: 20 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01692860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults
Official Title  ICMJE Effects of Milk Protein Concentrate on Blood Pressure, Inflammation, Muscle Health During Weight Loss in Overweight/Obese Adults
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Sarcopenia
  • Metabolic Disease
  • High Blood Pressure
Intervention  ICMJE Other: Energy Restriction
Subjects consume 750 kcal/d of energy below their need
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2015)
48
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2012)
70
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01692860
Other Study ID Numbers  ICMJE 1109011319
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wayne Campbell, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wayne W Campbell, Ph. D. Purdue University
PRS Account Purdue University
Verification Date November 2015

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