ObesityS-017NCT00812409
Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women
A study testing Whey protein supplementation with exercise in people with Obesity, run by Purdue University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Whey protein supplementation with exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity
- Being tested
- Whey protein supplementation with exercise, Non protein supplementation with exercise (control)
- Keywords
- Measuring markers of metabolic syndrome in overweight and obese adults.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein supplementation with exerciseDietary supplement
Whey protein supplementation with resistance and aerobic exercise.
Non protein supplementation with exercise (control)Other
Non protein supplementation with resistance and aerobic exercise.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Control group: non-protein supplement with resistance and aerobic exercise. Receives: Other: Non protein supplementation with exercise (control) |
| 2 | Experimental | Low protein supplement with resistance and aerobic exercise. Receives: Dietary Supplement: Whey protein supplementation with exercise |
| 3 | Experimental | Moderate protein supplement with resistance and aerobic exercise. Receives: Dietary Supplement: Whey protein supplementation with exercise |
| 4 | Experimental | High protein supplement with resistance and aerobic exercise. Receives: Dietary Supplement: Whey protein supplementation with exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of resistance and aerobic exercise and whey protein on body weight and body composition (fat mass and fat free mass).
Measured: 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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startApr 2007
- Primary completionJul 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, Ph.D., Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812409
- Sponsor's protocol ID
- 0611004694
- Other IDs
- 07053552
- Acronym
- S-017
- Status last verified
- Jan 2013
- First submitted
- 18 Dec 2008
- Last updated
- 17 Jan 2013
- Results posted
- No
Publications
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.
PubMed 28003538Wright 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.
PubMed 26446485Campbell 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.
PubMed 26246322Weinheimer 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.
PubMed 22718030
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women
- ClinicalTrials.gov ID
- NCT00812409
- Acronym / sponsor ID
- S-017 / 0611004694
- Conditions
- Obesity
- Keywords
- Measuring markers of metabolic syndrome in overweight and obese adults.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Non protein supplementation with exercise (control)Control group: non-protein supplement with resistance and aerobic exercise. |
| 2 | Experimental | Dietary Supplement: Whey protein supplementation with exerciseLow protein supplement with resistance and aerobic exercise. |
| 3 | Experimental | Dietary Supplement: Whey protein supplementation with exerciseModerate protein supplement with resistance and aerobic exercise. |
| 4 | Experimental | Dietary Supplement: Whey protein supplementation with exerciseHigh protein supplement with resistance and aerobic exercise. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein supplementation with exerciseWhey protein supplementation with resistance and aerobic exercise. | Dietary supplement | 2, 3, 4 |
| Non protein supplementation with exercise (control)Non protein supplementation with resistance and aerobic exercise. | Other | 1 |
Primary outcome
Influence of resistance and aerobic exercise and whey protein on body weight and body composition (fat mass and fat free mass).
Time frame: 36 weeks
1 secondary outcome
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.
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
- Derived from this study: PubMed 28003538Wright 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.
- Derived from this study: PubMed 26446485Wright 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.
- Derived from this study: PubMed 26246322Campbell 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.
- Derived from this study: PubMed 22718030Weinheimer 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne W Campbell, Ph.D. principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein supplementation with exercise in people with Obesity, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of resistance and aerobic exercise and whey protein on body weight and body composition (fat mass and fat free mass). (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00812409, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.