Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women

NCT ID: NCT00812409

Last Updated: 2013-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type EXPERIMENTAL

Non protein supplementation with exercise (control)

Intervention Type OTHER

Non protein supplementation with resistance and aerobic exercise.

2

Low protein supplement with resistance and aerobic exercise.

Group Type EXPERIMENTAL

Whey protein supplementation with exercise

Intervention Type DIETARY_SUPPLEMENT

Whey protein supplementation with resistance and aerobic exercise.

3

Moderate protein supplement with resistance and aerobic exercise.

Group Type EXPERIMENTAL

Whey protein supplementation with exercise

Intervention Type DIETARY_SUPPLEMENT

Whey protein supplementation with resistance and aerobic exercise.

4

High protein supplement with resistance and aerobic exercise.

Group Type EXPERIMENTAL

Whey protein supplementation with exercise

Intervention Type DIETARY_SUPPLEMENT

Whey protein supplementation with resistance and aerobic exercise.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whey protein supplementation with exercise

Whey protein supplementation with resistance and aerobic exercise.

Intervention Type DIETARY_SUPPLEMENT

Non protein supplementation with exercise (control)

Non protein supplementation with resistance and aerobic exercise.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* 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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Purdue University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wayne Campbell

Wayne Campbell, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wayne W Campbell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28003538 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26446485 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26246322 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22718030 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07053552

Identifier Type: -

Identifier Source: secondary_id

0611004694

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.