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

Study Overview
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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.

Official Title
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Effects of Milk Protein Concentrate on Blood Pressure, Inflammation, Muscle Health During Weight Loss in Overweight/Obese Adults

Conditions
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Sarcopenia, Metabolic Disease, High Blood Pressure

Intervention / Treatment
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* Other: Energy Restriction


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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