Measuring Eating, Activity and Strength: Understanding the Response -Using Protein (MEASUR-UP)
This study is currently recruiting participants.
Verified July 2012 by Duke University
Sponsor:
Duke University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01715753
First received: October 25, 2012
Last updated: October 26, 2012
Last verified: July 2012
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Purpose
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 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,
| Condition | Intervention |
|---|---|
|
Weight Loss |
Dietary Supplement: Protein supplementation Behavioral: Diet counseling and group education lessons |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults? |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Change in Short Physical Performance Battery (SPPB) [ Time Frame: Baseline to 3 to 6 months ] [ Designated as safety issue: No ]
- Change in lean body mass [ Time Frame: Baseline to 3 and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Weight Loss Control
Subjects follow a calorie-reduction diet for a weight loss of ≥10%.
|
Behavioral: Diet counseling and group education lessons
Individual and group diet counseling to achieve a >10% weight loss
|
|
Experimental: Weight Loss-High Protein
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.
|
Dietary Supplement: 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.
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 60+ yrs.
- BMI of >30 kg/m2
- Body weight <309 lbs.
- Normal blood chemistries
- Normal renal function
- Primary care physician acknowledgement
- Non-Vegetarian
- Mild to moderate movement impairment
Exclusion Criteria:
- Body weight >300 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).
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715753
Contacts
| Contact: Christine Ocampo, BS | 919-660-7507 | christine.ocampo@duke.edu |
| Contact: Kathryn Starr, PhD | 919-660-7571 | kathryn.starr@duke.edu |
Locations
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Christien Ocampo, BS 919-660-7507 christine.ocampo@duke.edu | |
| Contact: Kathryn Starr, PhD kathryn.starr@duke.edu | |
| Principal Investigator: Connie Bales, PhD | |
Sponsors and Collaborators
Duke University
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01715753 History of Changes |
| Other Study ID Numbers: | Pro00037110, 3834193 |
| Study First Received: | October 25, 2012 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Function Muscle mass |
Additional relevant MeSH terms:
|
Weight Loss Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013