NCT00812409

Brief Summary

The purpose of this study is to identify the influence of resistance and aerobic exercise with different nutritional supplements in middle-aged men and women on various physiological measures. Throughout the study, the investigators examine body composition, body weight, food intake, fitness level, metabolism, and blood hormones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
580

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable obesity

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

April 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

3.3 years

First QC Date

December 18, 2008

Last Update Submit

January 16, 2013

Conditions

Obesity

Keywords

Measuring markers of metabolic syndrome in overweight and obese adults.

Outcome Measures

Primary Outcomes (1)

  • Influence of resistance and aerobic exercise and whey protein on body weight and body composition (fat mass and fat free mass).

    36 weeks

Secondary Outcomes (1)

  • Influence of resistance and aerobic exercise and whey protein on dietary and macronutrient intakes, insulin-mediated glucose metabolism, physical fitness and markers of metabolic and cardiovascular health.

    36 weeks

Study Arms (4)

1

EXPERIMENTAL

Control group: non-protein supplement with resistance and aerobic exercise.

Other: Non protein supplementation with exercise (control)

2

EXPERIMENTAL

Low protein supplement with resistance and aerobic exercise.

Dietary Supplement: Whey protein supplementation with exercise

3

EXPERIMENTAL

Moderate protein supplement with resistance and aerobic exercise.

Dietary Supplement: Whey protein supplementation with exercise

4

EXPERIMENTAL

High protein supplement with resistance and aerobic exercise.

Dietary Supplement: Whey protein supplementation with exercise

Interventions

Whey protein supplementation with exerciseDIETARY_SUPPLEMENT

Whey protein supplementation with resistance and aerobic exercise.

234
Non protein supplementation with exercise (control)OTHER

Non protein supplementation with resistance and aerobic exercise.

1

Eligibility Criteria

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

You may qualify if:

  • men and women age 35-65 yr
  • body weight \<300 lbs (136 kg)
  • body mass index between 28 kg/m2 and 35 kg/m2
  • fasting glucose \<110 mg/dL
  • blood pressure \<160/100 mm Hg
  • plasma total cholesterol \<260 mg/dL
  • LDL-cholesterol \<160 mg/dL
  • triacylglycerol \<400 mg/dL
  • not currently or previously following a weight loss diet or other special/non-balanced diet (in the past 6 months)
  • \<1 hour/week of habitual aerobic exercise training and no resistance
  • exercise training (in the past 6 months)

You may not qualify if:

  • men and women age \< 35 yr or \>65 yr
  • body weight \>300 lbs (136 kg)
  • body mass index between \<28 kg/m2 or \>35 kg/m2
  • fasting glucose \>110 mg/dL
  • blood pressure \>160/100 mm Hg
  • plasma total cholesterol \>260 mg/dL
  • LDL-cholesterol \>160 mg/dL
  • triacylglycerol \>400 mg/dL
  • currently or previously following a weight loss diet or other special/non- balanced diet (in the past 6 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (4)

  • Wright CS, McMorrow AM, Weinheimer-Haus EM, Campbell WW. Whey Protein Supplementation and Higher Total Protein Intake Do Not Influence Bone Quantity in Overweight and Obese Adults Following a 36-Week Exercise and Diet Intervention. J Nutr. 2017 Feb;147(2):179-186. doi: 10.3945/jn.116.240473. Epub 2016 Dec 21.

    PMID: 28003538DERIVED

  • Wright CS, Weinheimer-Haus EM, Fleet JC, Peacock M, Campbell WW. The Apparent Relation between Plasma 25-Hydroxyvitamin D and Insulin Resistance is Largely Attributable to Central Adiposity in Overweight and Obese Adults. J Nutr. 2015 Dec;145(12):2683-9. doi: 10.3945/jn.115.220541. Epub 2015 Oct 7.

    PMID: 26446485DERIVED

  • Campbell WW, Kim JE, Amankwaah AF, Gordon SL, Weinheimer-Haus EM. Higher Total Protein Intake and Change in Total Protein Intake Affect Body Composition but Not Metabolic Syndrome Indexes in Middle-Aged Overweight and Obese Adults Who Perform Resistance and Aerobic Exercise for 36 Weeks. J Nutr. 2015 Sep;145(9):2076-83. doi: 10.3945/jn.115.213595. Epub 2015 Aug 5.

    PMID: 26246322DERIVED

  • Weinheimer EM, Conley TB, Kobza VM, Sands LP, Lim E, Janle EM, Campbell WW. Whey protein supplementation does not affect exercise training-induced changes in body composition and indices of metabolic syndrome in middle-aged overweight and obese adults. J Nutr. 2012 Aug;142(8):1532-9. doi: 10.3945/jn.111.153619. Epub 2012 Jun 20.

    PMID: 22718030DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wayne Campbell, Ph.D.

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 22, 2008

Study Start

April 1, 2007

Primary Completion

July 1, 2010

Study Completion

September 1, 2010

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)