Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of High Protein Weight Loss for Seniors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02730988
Recruitment Status : Completed
First Posted : April 7, 2016
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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).


Condition or disease Intervention/treatment Phase
Obesity Weight Loss Behavioral: Weight Stable Group Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of High Protein Weight Loss for Seniors
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : April 17, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Weight Loss Lifestyle Counseling
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
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.

Active Comparator: Weight Stable Lifestyle Counseling
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
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.




Primary Outcome Measures :
  1. Change in 400 Meter Gait Walk Speed [ Time Frame: baseline and 24 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in 24-week Lean Mass Body Composition [ Time Frame: Baseline and 24-weeks ]
    Lean mass assessed by whole-body DXA and reported in kg



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730988


Locations
Layout table for location information
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27106
Sponsors and Collaborators
Wake Forest University
Wake Forest University Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: Kristen M Beavers, PhD Wake Forest University
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences ( Wake Forest University ):

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT02730988     History of Changes
Other Study ID Numbers: IRB00033428
First Posted: April 7, 2016    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes