Measuring Eating, Activity and Strength: Understanding the Response -Using Protein (MEASUR-UP)

Duke University

Status: Completed

Conditions: Weight Loss

Treatments: Dietary Supplement: Protein supplementation; Behavioral: Diet counseling and group education lessons

Study type: Interventional

Funder types: Other

Identifiers

NCT01715753

Pro00037110

3834193 (Other Grant/Funding Number)

Details and patient eligibility

About

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)

Enrollment: 71 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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).
• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Weight Loss Control

Active Comparator group

Description:

Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.

Treatment:

Behavioral: Diet counseling and group education lessons

Weight Loss-High Protein

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Protein supplementation