Weight LossMEASUR-UPNCT01715753
Measuring Eating, Activity and Strength: Understanding the Response -Using Protein
A study testing Protein supplementation and Diet counseling and group education lessons in people with Weight Loss, run by Duke University at 1 site in United States.
Trial summary
The purpose of the trial is to assess the effects of weight loss on functional status and lean muscle mass in frail, obese older adults (>/= 60) who participate in a 6 month weight reduction intervention. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Weight Loss
- 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
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2014
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60+ 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 University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults?
The purpose of the trial is to assess the effects of weight loss on functional status and lean muscle mass in frail, obese older adults (>/= 60) who participate in a 6 month weight reduction intervention. Participants will be randomized into one of two study arms: Weight Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or Weight Loss-High Protein: (n = 50) 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 beef. Subject criteria will include obese (>30 kg/m2) older adults (>60 yrs.) with mild to moderate functional impairment (by Short Physical Performance Battery; SPPB score >/= 4)
- Conditions
- Weight Loss
- Being tested
- Protein supplementation, Diet counseling and group education lessons
- Keywords
- Function, Muscle mass
- Medical subject headings
- Weight Loss
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 beef.
Diet counseling and group education lessonsBehavioural
Individual and group diet counseling to achieve a >10% weight loss
| Study group | Role | What they receive |
|---|---|---|
| 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 |
| 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 60-70% of animal protein from beef. Receives: Dietary Supplement: Protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Physical Performance Battery (SPPB)
short physical performance battery
Measured: Baseline to 3 to 6 months
Change in lean body mass
Bodpod
Measured: Baseline to 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Connie W Bales, PhD, RD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715753
- Sponsor's protocol ID
- Pro00037110
- Other IDs
- 3834193
- Acronym
- MEASUR-UP
- Status last verified
- Mar 2018
- First submitted
- 25 Oct 2012
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Porter Starr KN, Orenduff M, McDonald SR, Mulder H, Sloane R, Pieper CF, Bales CW. Influence of Weight Reduction and Enhanced Protein Intake on Biomarkers of Inflammation in Older Adults with Obesity. J Nutr Gerontol Geriatr. 2019 Jan-Mar;38(1):33-49. doi: 10.1080/21551197.2018.1564200. Epub 2019 Feb 27.
PubMed 30810500Payne ME, Porter Starr KN, Orenduff M, Mulder HS, McDonald SR, Spira AP, Pieper CF, Bales CW. Quality of Life and Mental Health in Older Adults with Obesity and Frailty: Associations with a Weight Loss Intervention. J Nutr Health Aging. 2018;22(10):1259-1265. doi: 10.1007/s12603-018-1127-0.
PubMed 30498835Porter Starr KN, Pieper CF, Orenduff MC, McDonald SR, McClure LB, Zhou R, Payne ME, Bales CW. Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1369-75. doi: 10.1093/gerona/glv210. Epub 2016 Jan 18.
PubMed 26786203McDonald SR, Porter Starr KN, Mauceri L, Orenduff M, Granville E, Ocampo C, Payne ME, Pieper CF, Bales CW. Meal-based enhancement of protein quality and quantity during weight loss in obese older adults with mobility limitations: rationale and design for the MEASUR-UP trial. Contemp Clin Trials. 2015 Jan;40:112-23. doi: 10.1016/j.cct.2014.11.010. Epub 2014 Nov 20.
PubMed 25461495
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults?
- ClinicalTrials.gov ID
- NCT01715753
- Acronym / sponsor ID
- MEASUR-UP / Pro00037110
- Conditions
- Weight Loss
- Keywords
- Function, Muscle mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Oct 2012 (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 weight loss on functional status and lean muscle mass in frail, obese older adults (>/= 60) who participate in a 6 month weight reduction intervention. Participants will be randomized into one of two study arms: Weight Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or Weight Loss-High Protein: (n = 50) 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 beef. Subject criteria will include obese (>30 kg/m2) older adults (>60 yrs.) with mild to moderate functional impairment (by Short Physical Performance Battery; SPPB score >/= 4)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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%. |
| Weight Loss-High Protein | Experimental | Dietary Supplement: Protein supplementationProtein 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 60-70% of animal protein from beef. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 60+ 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 beef. | Dietary supplement | Weight Loss-High Protein |
| Diet counseling and group education lessonsIndividual and group diet counseling to achieve a >10% weight loss | Behavioural | Weight Loss Control |
Primary outcome
Change in Short Physical Performance Battery (SPPB)
Time frame: Baseline to 3 to 6 months
short physical performance battery
Change in lean body mass
Time frame: Baseline to 3 and 6 months
Bodpod
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 12 Dec 2018.
- Derived from this study: PubMed 30810500Porter Starr KN, Orenduff M, McDonald SR, Mulder H, Sloane R, Pieper CF, Bales CW. Influence of Weight Reduction and Enhanced Protein Intake on Biomarkers of Inflammation in Older Adults with Obesity. J Nutr Gerontol Geriatr. 2019 Jan-Mar;38(1):33-49. doi: 10.1080/21551197.2018.1564200. Epub 2019 Feb 27.
- Derived from this study: PubMed 30498835Payne ME, Porter Starr KN, Orenduff M, Mulder HS, McDonald SR, Spira AP, Pieper CF, Bales CW. Quality of Life and Mental Health in Older Adults with Obesity and Frailty: Associations with a Weight Loss Intervention. J Nutr Health Aging. 2018;22(10):1259-1265. doi: 10.1007/s12603-018-1127-0.
- Derived from this study: PubMed 26786203Porter Starr KN, Pieper CF, Orenduff MC, McDonald SR, McClure LB, Zhou R, Payne ME, Bales CW. Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1369-75. doi: 10.1093/gerona/glv210. Epub 2016 Jan 18.
- Derived from this study: PubMed 25461495McDonald SR, Porter Starr KN, Mauceri L, Orenduff M, Granville E, Ocampo C, Payne ME, Pieper CF, Bales CW. Meal-based enhancement of protein quality and quantity during weight loss in obese older adults with mobility limitations: rationale and design for the MEASUR-UP trial. Contemp Clin Trials. 2015 Jan;40:112-23. doi: 10.1016/j.cct.2014.11.010. Epub 2014 Nov 20.
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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, 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 12 Dec 2018. 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?
Change in Short Physical Performance Battery (SPPB) (time frame: Baseline to 3 to 6 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 NCT01715753, 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 12 Dec 2018.