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

NCT ID: NCT01692860

Last Updated: 2015-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-01-31

Brief Summary

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. 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

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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.

Conditions

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Sarcopenia Metabolic Disease High Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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High protein consumption

Intervention, energy restriction. This arm has a dietary protein intake of 1.5g/kg/d

Group Type EXPERIMENTAL

Energy Restriction

Intervention Type OTHER

Subjects consume 750 kcal/d of energy below their need

Normal protein consumption

Intervention, energy restriction. This arm has a dietary protein intake of .8g/kg/d

Group Type PLACEBO_COMPARATOR

Energy Restriction

Intervention Type OTHER

Subjects consume 750 kcal/d of energy below their need

Interventions

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Energy Restriction

Subjects consume 750 kcal/d of energy below their need

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Wayne Campbell

Wayne Campbell, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wayne W Campbell, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

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Purdue University - Stone Hall 700 W State St

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26864362 (View on PubMed)

Other Identifiers

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1109011319

Identifier Type: -

Identifier Source: org_study_id

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