Clinical trial NCT01692860: Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults
Official title: Effects of Milk Protein Concentrate on Blood Pressure, Inflammation, Muscle Health During Weight Loss in Overweight/Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Metabolic Disease
High Blood Pressure
Keywords: 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
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 48
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: weight loss
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: W Lafayette
country: United States
facility: Purdue University - Stone Hall 700 W State St
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.