Effect of High Protein Weight Loss for Seniors

NCT02730988 | Completed Results DMC

• 1 other identifier: IRB00033428
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Intentional weight loss in obese, older adults remains controversial. Although caloric restriction, resulting in significant weight and fat mass loss, ameliorates many clinical consequences of obesity, recommendation of intentional weight loss in aging remains controversial. Reluctance stems, at least in part, from loss of lean and bone mass known to accompany overall weight loss and potential exacerbation of age-related risk of disability and fracture. Accordingly, current treatment guidelines call fhttp://google.wfu.edu/or weight-loss therapy that minimizes muscle and bone losses for older persons who are obese and who have functional impairments or medical complications that can benefit from weight loss. Amount of dietary protein consumed during caloric restriction may be a key determinant in maintaining fat-free mass during weight loss. Adequate dietary protein is essential for skeletal muscle anabolism; and, epidemiological evidence in older adults point to a salutary effect of protein intake above the current RDA (0.8 g/kg/day) on body composition. Indeed, a recent position statement by the PRO-TAGE study group advises consumption of 1.0-1.2 g/kg/d in older adults during weight-stable conditions to aid in the maintenance of lean body mass and function. Practical achievement of this level of protein intake is often difficult for obese, older adults undergoing weight loss, yet may be critical to offset weight loss-associated lean mass loss. Preliminary data from our group show a lean mass sparing effect of high protein consumption during caloric restriction. In post-menopausal women undergoing a 5-month intentional weight loss program, consumption of a high (1.2 g/kg/day) versus low (0.6 g/kg/day) protein diet was associated with 50% attenuation (17% vs. 37%) of lean mass loss. While promising, results have yet to be translated to functional changes in a tightly controlled trial of weight loss in obese, older adults. The primary goal of this study is to determine whether adherence to a high protein (≥1.0 g/kg/d) weight loss program results in improved physical function by favorably affecting body composition compared to weight stability in obese, older adults. This will be accomplished by conducting a 24-week trial in 124 obese (BMI 30-40 kg/m2), older (65-79 years) men and women, at risk for mobility disability, randomized to either: (1) high protein intake (≥1.0 g/kg/d; n=62) during weight loss, or (2) weight-stable control (n=62).

Conditions

Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Change in 400 Meter Gait Walk Speed

  Participants were asked to walk 10 laps of a 40-meter course (20 meters out and 20 meters back). The time it took to complete the 400 meters was calculated and reported in meters/second.

  baseline and 24 weeks

Secondary Outcomes (1)

• Change in 24-week Lean Mass Body Composition

  Baseline and 24-weeks

Study Arms (2)

Weight Loss Lifestyle Counseling

EXPERIMENTAL

The high protein weight loss group follows the Medifast 4 \& 2 \& 1 Plan™, a 1200 calorie, high protein diet targeting \~10% weight loss over 24-weeks through a combination of meal replacement products (MRPs), meal plans, and individual nutrition/behavioral counseling. Participants are guided by the study RD on food purchasing and preparation and encouraged to consume only what is approved from the menu. Participants meet bi-weekly for RD-lead behavioral counseling group classes to provide support and introduce new topics in behavioral weight control. Weight is also measured at each session with progress feedback provided to increase motivation. Participants complete daily food logs to verify compliance to the diet.

Behavioral: Weight Stable Group

Weight Stable Lifestyle Counseling

ACTIVE COMPARATOR

The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff. If participants attend 75% of the educational sessions, all baseline and follow-up testing sessions, and maintain weight stability over the course of the study (defined as less than a 5% differential between weight measured at week 0 and 24), they will be eligible to receive up to 3 months of Medifast MRPs along with a 30-60 minute RD-led dietary instruction session on how to follow the Medifast 4 \& 2 \& 1 Plan.

Behavioral: Weight Stable Group

Interventions

Weight Stable Group BEHAVIORAL

The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff. If participants attend 75% of the educational sessions, all baseline and follow-up testing sessions, and maintain weight stability over the course of the study (defined as less than a 5% differential between weight measured at week 0 and 24), they will be eligible to receive up to 3 months of Medifast MRPs along with a 30-60 minute RD-led dietary instruction session on how to follow the Medifast 4 \& 2 \& 1 Plan.

Weight Loss Lifestyle Counseling; Weight Stable Lifestyle Counseling

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65-79 years
• BMI=30-40 kg/m2
• Confirmation of self-reported mobility disability, as assessed by phone screen/clinical staff
• Self-reported sedentary behavior
• Non-impaired cognitive function (MoCA\>18)
• Stability of residence for next 2 years
• Willing and able to follow dietary protocol
• Willing to provide informed consent
• Approved for participation by study physician
• Not involved in another behavioral or interventional research study
• Able to provide own transportation to study visits and Intervention
• Not dependent on a cane or walker
• No evidence of clinical depression, eating disorder, or other contraindications for participation in voluntary weight loss
• English literacy

You may not qualify if:

• Weight loss or gain (±5%) in past 6 months
• Prior bariatric surgery
• Multiple food allergies
• Difficulty with hearing/vision that interferes with study participation
• Excessive alcohol use (\>14 drinks/week)
• Smoker (\>1 cigarette/d within year)
• Insulin-dependent or uncontrolled diabetes (FBG \>140 mg/dl)
• Uncontrolled hypertension (BP\>160/100 mmHg)
• Abnormal kidney tests (GFR\<40, creatinine \>2.0)
• Regular use of medications that may influence body weight or composition
• Severe systemic disease (diagnosis of Parkinson's disease, chronic liver disease, systemic rheumatic condition, gout, thyroid disease, end stage renal disease) or other systemic diseases/abnormal laboratory values which would preclude participants from safely participating in the protocol or impair their ability to complete the study
• Severe symptomatic heart disease or cardiovascular procedure within the past 3 months or history/current diagnosis/signs and symptoms of heart failure, with either reduced or preserved Left Ventricular ejection fraction
• Cancer requiring treatment in past year, except skin cancers
• Judged unsuitable for the trial for any reason by clinic staff

Sponsors & Collaborators

• Wake Forest University: lead
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27106, United States

Location

Related Publications (1)

• Weaver AA, Houston DK, Shapses SA, Lyles MF, Henderson RM, Beavers DP, Baker AC, Beavers KM. Effect of a hypocaloric, nutritionally complete, higher-protein meal plan on bone density and quality in older adults with obesity: a randomized trial. Am J Clin Nutr. 2019 Feb 1;109(2):478-486. doi: 10.1093/ajcn/nqy237.

  PMID: 30624598 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Kristen Beavers
• Organization: Wake Forest University

beaverkm@wfu.edu

3367585855

Study Officials

• Kristen M Beavers, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2016
• First Posted: April 7, 2016
• Study Start: July 1, 2015
• Primary Completion: March 30, 2017
• Study Completion: April 17, 2017
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)