Weight LossPOWR-UPNCT02033655
A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women
A study testing Protein supplementation and Diet counseling and group education lessons in people with Weight Loss and Obesity, run by Duke University at 1 site in United States.
Trial summary
The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month… Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Weight Loss, Obesity
- What is being tested?
- Protein supplementation and Diet counseling and group education lessons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 22 Aug 2018
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45+ yrs.
- BMI of >30 kg/m2
- Body weight <495 lbs.
- Normal blood chemistries
- Normal renal function
- Primary care physician acknowledgement
- Non-Vegetarian
- Mild to moderate movement impairment
Who cannot join
- Body weight >495 pounds.
- Current smoker.
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Positive screen for dementia using Mini-Cog evaluation tool.
- Neurological conditions causing functional or cognitive impairments.
- History of significant weight instability (defined as > 10 pounds weight gain or loss over 6 months prior to study participation).
Show all 13Show fewer
- Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing or continuously participate in a randomly assigned lifestyle intervention program for six months.
- Inability to walk independently.
- Bilateral hip replacements.
- Unable to give consent.
- Unable to complete written recording forms including journals of eating and exercise behaviors.
- Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications.
- Primary Care Physician advises against participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Universtiy Medical Center
Durham, North Carolina, 27710
About this study
The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month intervention.
Read the detailed description
Assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month intervention.
For 6 month intervention: Participants will be randomized into one of two study arms: Weight Loss Control (n = 20) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or Weight Loss-High Protein: (n = 40) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from pork. Subject criteria will include obese (>30 kg/m2) women (≥ 45 yrs.) with mild to moderate functional impairment (by 6 minute walk).
For 9 month intervention: Participants will be randomized into one of two study arms: Weight Loss Control (n = 10) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or Weight Loss-High Protein: (n = 10) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from pork. Subject criteria will include obese (≥ 30 kg/m2) women (≥ 60 yrs.) with mild to moderate functional impairment (by 6 minute walk).
This is a randomized clinical trial with repeated measurements, with the purpose of assessing change over time for the overall sample and the difference in the High Protein group relative to the Control group with regards to primary outcomes (function and lean body mass). The statistical analyses will proceed chronologically in 3 phases: 1) descriptive analyses that will summarize the distribution of the covariates and dependent variables, 2) bivariate analyses of the association between group membership and the outcome measures, and 3) controlled multivariable analyses, which assess the association between experimental group and the outcomes, controlling for the important covariates.
- Conditions
- Weight Loss, Obesity
- Being tested
- Protein supplementation, Diet counseling and group education lessons
- Keywords
- weight loss, older adults, obesity
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementationDietary supplement
> 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from lean pork.
Diet counseling and group education lessonsBehavioural
Participants meet once a week for 6 months to participate in group lessons and counseling.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss high protein | Experimental | Protein supplementation. Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of protein, including substantial amounts of supplemental protein provided as lean beef. Intakes of > 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60% of animal protein from pork. Receives: Dietary Supplement: Protein supplementation; Behavioral: Diet counseling and group education lessons |
| Weight loss control | Active comparator | Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%. Receives: Behavioral: Diet counseling and group education lessons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Assess the change in 6 minute walk scores at 4, 6, and 9 months
Measured: Baseline, 4, 6, and 9 months
Lean Mass
To assess the change in lean mass at 3 or 4 time points.
Measured: Baseline, 4, 6, and 9 months
Secondary outcomes (3)
Physical Function
To assess the change in SPPB at 4, 6, and 9 months
Measured: Baseline, 4, 6, and 9 months
Weight Loss
To assess the change in body weight at 4, 6, and 9 months
Measured: Baseline, 4, 6, and 9 months
Fat Mass
To assess the change in fat mass at 4, 6, and 9 months
Measured: Baseline, 4, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startMar 2014
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Pork Board
- Responsible party
- Sponsor
- Investigators
- Connie W Bales, PhD, RD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033655
- Sponsor's protocol ID
- Pro00050540
- Acronym
- POWR-UP
- Status last verified
- Sep 2018
- First submitted
- 9 Jan 2014
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bales CW, Porter Starr KN, Orenduff MC, McDonald SR, Molnar K, Jarman AK, Onyenwoke A, Mulder H, Payne ME, Pieper CF. Influence of Protein Intake, Race, and Age on Responses to a Weight-Reduction Intervention in Obese Women. Curr Dev Nutr. 2017 May 1;1(5):e000703. doi: 10.3945/cdn.117.000703. Epub 2017 Apr 11.
PubMed 29517074
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women
- ClinicalTrials.gov ID
- NCT02033655
- Acronym / sponsor ID
- POWR-UP / Pro00050540
- Conditions
- Weight Loss, Obesity
- Keywords
- weight loss, older adults, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Pork Board
- Study start
- Mar 2014
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 13 Jan 2014 (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 the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month intervention.
Detailed description
Assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month intervention.
For 6 month intervention: Participants will be randomized into one of two study arms: Weight Loss Control (n = 20) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or Weight Loss-High Protein: (n = 40) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from pork. Subject criteria will include obese (>30 kg/m2) women (≥ 45 yrs.) with mild to moderate functional impairment (by 6 minute walk).
For 9 month intervention: Participants will be randomized into one of two study arms: Weight Loss Control (n = 10) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or Weight Loss-High Protein: (n = 10) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from pork. Subject criteria will include obese (≥ 30 kg/m2) women (≥ 60 yrs.) with mild to moderate functional impairment (by 6 minute walk).
This is a randomized clinical trial with repeated measurements, with the purpose of assessing change over time for the overall sample and the difference in the High Protein group relative to the Control group with regards to primary outcomes (function and lean body mass). The statistical analyses will proceed chronologically in 3 phases: 1) descriptive analyses that will summarize the distribution of the covariates and dependent variables, 2) bivariate analyses of the association between group membership and the outcome measures, and 3) controlled multivariable analyses, which assess the association between experimental group and the outcomes, controlling for the important covariates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss high protein | Experimental | Dietary Supplement: Protein supplementation, Behavioral: Diet counseling and group education lessonsProtein supplementation. Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of protein, including substantial amounts of supplemental protein provided as lean beef. Intakes of > 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60% of animal protein from pork. |
| Weight loss control | Active comparator | Behavioral: Diet counseling and group education lessonsDiet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 45+ yrs.
- BMI of >30 kg/m2
- Body weight <495 lbs.
- Normal blood chemistries
- Normal renal function
Key exclusion criteria (13 listed)
- Body weight >495 pounds.
- Current smoker.
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Positive screen for dementia using Mini-Cog evaluation tool.
- Neurological conditions causing functional or cognitive impairments.
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 |
|---|---|---|
| Protein supplementation> 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from lean pork. | Dietary supplement | Weight loss high protein |
| Diet counseling and group education lessonsParticipants meet once a week for 6 months to participate in group lessons and counseling. | Behavioural | Weight loss control, Weight loss high protein |
Primary outcome
Physical function
Time frame: Baseline, 4, 6, and 9 months
Assess the change in 6 minute walk scores at 4, 6, and 9 months
Lean Mass
Time frame: Baseline, 4, 6, and 9 months
To assess the change in lean mass at 3 or 4 time points.
3 secondary outcomes
Physical Function
Time frame: Baseline, 4, 6, and 9 months
Weight Loss
Time frame: Baseline, 4, 6, and 9 months
Fat Mass
Time frame: Baseline, 4, 6, and 9 months
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 8 Jan 2019.
- Derived from this study: PubMed 29517074Bales CW, Porter Starr KN, Orenduff MC, McDonald SR, Molnar K, Jarman AK, Onyenwoke A, Mulder H, Payne ME, Pieper CF. Influence of Protein Intake, Race, and Age on Responses to a Weight-Reduction Intervention in Obese Women. Curr Dev Nutr. 2017 May 1;1(5):e000703. doi: 10.3945/cdn.117.000703. Epub 2017 Apr 11.
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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.
Connie W Bales, PhD, RD principal investigator
Duke 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 Protein supplementation and Diet counseling and group education lessons in people with Weight Loss and Obesity, run by Duke 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 8 inclusion and 13 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 8 Jan 2019. 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?
Physical function (time frame: Baseline, 4, 6, and 9 months). The study lists 2 primary outcomes in all. 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 NCT02033655, which also lists 1 linked publication.
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 8 Jan 2019.