NCT01692860

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

November 4, 2015

Status Verified

November 1, 2015

Enrollment Period

2.7 years

First QC Date

September 21, 2012

Last Update Submit

November 3, 2015

Conditions

Keywords

the impact of a higher dairy-based protein diet incombination with energy restriction on muscle health,metabolic health (including blood pressure) in overweightand obese, middle aged adults

Outcome Measures

Primary Outcomes (1)

  • weight loss

    20 weeks

Study Arms (2)

High protein consumption

EXPERIMENTAL

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

Other: Energy Restriction

Normal protein consumption

PLACEBO COMPARATOR

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

Other: Energy Restriction

Interventions

Subjects consume 750 kcal/d of energy below their need

High protein consumptionNormal protein consumption

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University - Stone Hall 700 W State St

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SarcopeniaMetabolic DiseasesHypertensionObesity

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsNutritional and Metabolic DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersBody Weight

Study Officials

  • Wayne W Campbell, Ph. D.

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wayne Campbell, Ph.D.

Study Record Dates

First Submitted

September 21, 2012

First Posted

September 25, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2014

Study Completion

January 1, 2015

Last Updated

November 4, 2015

Record last verified: 2015-11

Locations