Bone and Body CompositionPhase 1NCT00912210
Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
A Phase 1 study testing Whey protein isolate and Maltodextrin powder supplement in people with Bone and Body Composition and Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The broad aim is to determine efficacy of a weight loss diet higher in protein and lower in carbohydrate combined with low intensity exercise to favorably impact body composition, bone health, physical function, metabolic disease and quality of life compared to a conventional higher carbohydrate diet in overweight… Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone and Body Composition, Obesity, Metabolic Syndrome
- What is being tested?
- Whey protein isolate and Maltodextrin powder supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to not given
- Phase
- Phase 1
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index > 28 kg/m²
- Clearance of primary physician to participate in diet and mild exercise
Who cannot join
- Medical condition contraindicating prescribed diet and exercise regimen
- Type 2 Diabetes Mellitus
- Physically active lifestyle (>30 min moderate physical activity 2+ times weekly)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
The broad aim is to determine efficacy of a weight loss diet higher in protein and lower in carbohydrate combined with low intensity exercise to favorably impact body composition, bone health, physical function, metabolic disease and quality of life compared to a conventional higher carbohydrate diet in overweight women over age 60.
- Conditions
- Bone and Body Composition, Obesity, Metabolic Syndrome, Physical Function, Quality of Life
- Being tested
- Whey protein isolate, Maltodextrin powder supplement
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein isolateDietary supplement
Loss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50g/day (two 25 g doses taken at breakfast and afternoon snack mixed with food or beverage)
Maltodextrin powder supplementDietary supplement
Also called carbohydrate, starch
Loss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50 g / day (two 25 g doses at breakfast and afternoon snack mixed with food or beverage)
| Study group | Role | What they receive |
|---|---|---|
| Higher protein | Active comparator | Not described Receives: Dietary Supplement: Whey protein isolate |
| Higher carbohydrate | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin powder supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone and body composition: Weight, percent fat, muscle and fat distribution in the thigh and abdomen and bone density and structural quality assessed by DXA and structural MRI
Measured: Baseline and post 6 months weight loss
Secondary outcomes (4)
Physical function: balance, gait, strength and activities of daily living
Measured: Baseline and post 6 months weight loss
Quality of life
Measured: Baseline and post 6 months weight loss
Metabolic syndrome: insulin resistance, blood pressure, blood lipids, waist circumference
Measured: Baseline and post 6 months weight loss
Acid-base balance
Measured: Baseline and post 1 and 6 months weight loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Body CompositionStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Investigators
- Ellen M Evans, PhD, Principal investigator, University of Illinois at Urbana-ChampaignDonald K Layman, PhD, Principal investigator, University of Illinois at Urbana-ChampaignEdward McAuley, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912210
- Sponsor's protocol ID
- UIUC IRB 07782
- Status last verified
- May 2009
- First submitted
- 29 May 2009
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
- ClinicalTrials.gov ID
- NCT00912210
- Acronym / sponsor ID
- UIUC IRB 07782
- Conditions
- Bone and Body Composition, Obesity, Metabolic Syndrome, Physical Function, Quality of Life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Apr 2009
- First posted
- 3 Jun 2009 (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 broad aim is to determine efficacy of a weight loss diet higher in protein and lower in carbohydrate combined with low intensity exercise to favorably impact body composition, bone health, physical function, metabolic disease and quality of life compared to a conventional higher carbohydrate diet in overweight women over age 60.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher protein | Active comparator | Dietary Supplement: Whey protein isolate |
| Higher carbohydrate | Placebo comparator | Dietary Supplement: Maltodextrin powder supplement |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index > 28 kg/m²
- Clearance of primary physician to participate in diet and mild exercise
Key exclusion criteria (3 listed)
- Medical condition contraindicating prescribed diet and exercise regimen
- Type 2 Diabetes Mellitus
- Physically active lifestyle (>30 min moderate physical activity 2+ times weekly)
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 isolateLoss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50g/day (two 25 g doses taken at breakfast and afternoon snack mixed with food or beverage) | Dietary supplement | Higher protein |
| Maltodextrin powder supplementAlso: carbohydrate, starchLoss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50 g / day (two 25 g doses at breakfast and afternoon snack mixed with food or beverage) | Dietary supplement | Higher carbohydrate |
Primary outcome
Bone and body composition: Weight, percent fat, muscle and fat distribution in the thigh and abdomen and bone density and structural quality assessed by DXA and structural MRI
Time frame: Baseline and post 6 months weight loss
4 secondary outcomes
Physical function: balance, gait, strength and activities of daily living
Time frame: Baseline and post 6 months weight loss
Quality of life
Time frame: Baseline and post 6 months weight loss
Metabolic syndrome: insulin resistance, blood pressure, blood lipids, waist circumference
Time frame: Baseline and post 6 months weight loss
Acid-base balance
Time frame: Baseline and post 1 and 6 months weight loss
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 3 Jun 2009.
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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.
Ellen M Evans, PhD principal investigator
University of Illinois at Urbana-Champaign
Donald K Layman, PhD principal investigator
University of Illinois at Urbana-Champaign
Edward McAuley, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Whey protein isolate and Maltodextrin powder supplement in people with Bone and Body Composition and Obesity, run by University of Illinois at Urbana-Champaign 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 2 inclusion and 3 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 3 Jun 2009. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bone and body composition: Weight, percent fat, muscle and fat distribution in the thigh and abdomen and bone density and structural quality assessed by DXA and structural MRI (time frame: Baseline and post 6 months weight loss). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2009.