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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT01692860
First received: September 21, 2012
Last updated: November 3, 2015
Last verified: November 2015
  Purpose
. 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

Condition Intervention
Sarcopenia
Metabolic Disease
High Blood Pressure
Other: Energy Restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Milk Protein Concentrate on Blood Pressure, Inflammation, Muscle Health During Weight Loss in Overweight/Obese Adults

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • weight loss [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2012
Study Completion Date: January 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692860

Locations
United States, Indiana
Purdue University - Stone Hall 700 W State St
W Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Wayne W Campbell, Ph. D. Purdue University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wayne Campbell, Wayne Campbell, Ph.D., Purdue University
ClinicalTrials.gov Identifier: NCT01692860     History of Changes
Other Study ID Numbers: 1109011319 
Study First Received: September 21, 2012
Last Updated: November 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
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

Additional relevant MeSH terms:
Overweight
Weight Loss
Sarcopenia
Metabolic Diseases
Hypertension
Body Weight
Signs and Symptoms
Body Weight Changes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 25, 2016