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

November 3, 2015 updated by: Wayne Campbell, Purdue University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • W Lafayette, Indiana, United States, 47907
        • Purdue University - Stone Hall 700 W State St

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High protein consumption
Intervention, energy restriction. This arm has a dietary protein intake of 1.5g/kg/d
Other: Energy Restriction
Subjects consume 750 kcal/d of energy below their need
Placebo Comparator: Normal protein consumption
Intervention, energy restriction. This arm has a dietary protein intake of .8g/kg/d
Other: Energy Restriction
Subjects consume 750 kcal/d of energy below their need

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight loss
Time Frame: 20 weeks
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Investigators

  • Principal Investigator: Wayne W Campbell, Ph. D., Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Estimate)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1109011319

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcopenia

Clinical Trials on Energy Restriction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe