Trial Outcomes & Findings for Effect of High Protein Weight Loss for Seniors (NCT NCT02730988)

NCT ID: NCT02730988

Last Updated: 2019-01-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 96 participants
• Primary outcome timeframe: baseline and 24 weeks
• Results posted on: 2019-01-23

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	47	49
Overall Study COMPLETED	43	39
Overall Study NOT COMPLETED	4	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of High Protein Weight Loss for Seniors

Baseline characteristics by cohort

Measure	Weight Loss Lifestyle Counseling n=47 Participants 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.	Weight Stable Lifestyle Counseling n=49 Participants 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.	Total n=96 Participants Total of all reporting groups
Age, Continuous	71.4 years STANDARD_DEVIATION 3.9 • n=93 Participants	69.2 years STANDARD_DEVIATION 3.1 • n=4 Participants	70.3 years STANDARD_DEVIATION 3.7 • n=27 Participants
Sex: Female, Male Female	35 Participants n=93 Participants	36 Participants n=4 Participants	71 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	13 Participants n=4 Participants	25 Participants n=27 Participants
Race/Ethnicity, Customized African American	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	33 Participants n=93 Participants	35 Participants n=4 Participants	68 Participants n=27 Participants
Region of Enrollment United States	47 Participants n=93 Participants	49 Participants n=4 Participants	96 Participants n=27 Participants

PRIMARY outcome

Timeframe: baseline and 24 weeks

Population: Number analyzed reflects those who completed both baseline and 24 week followup testing since both trials needed to show change in 400 meter walk distance and 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.

Outcome measures

Measure	Weight Loss Lifestyle Counseling n=42 Participants 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.	Weight Stable Lifestyle Counseling n=38 Participants 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.
Change in 400 Meter Gait Walk Speed	0.01 meters/second Interval -0.02 to 0.04	-0.02 meters/second Interval -0.05 to 0.01

SECONDARY outcome

Timeframe: Baseline and 24-weeks

Population: in order to see degree of change, analysis includes participants who obtained DXA scans at both baseline and 24 weeks. Not all participants completed the baseline and final, 24-week follow-up scans.

Lean mass assessed by whole-body DXA and reported in kg

Outcome measures

Measure	Weight Loss Lifestyle Counseling n=41 Participants 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.	Weight Stable Lifestyle Counseling n=39 Participants 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.
Change in 24-week Lean Mass Body Composition	-0.81 kg Interval -1.4 to -0.23	-0.24 kg Interval -0.85 to 0.36

Adverse Events

Weight Loss Lifestyle Counseling

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Weight Stable Lifestyle Counseling

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Weight Loss Lifestyle Counseling n=47 participants at risk 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.	Weight Stable Lifestyle Counseling n=49 participants at risk 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.
Ear and labyrinth disorders Vertigo/ear infection	0.00% 0/47 • 6 months from baseline	2.0% 1/49 • Number of events 1 • 6 months from baseline
Musculoskeletal and connective tissue disorders Knee replacement	2.1% 1/47 • Number of events 1 • 6 months from baseline	0.00% 0/49 • 6 months from baseline
Gastrointestinal disorders Bowel obstruction	2.1% 1/47 • Number of events 1 • 6 months from baseline	0.00% 0/49 • 6 months from baseline
Gastrointestinal disorders Colitis	0.00% 0/47 • 6 months from baseline	2.0% 1/49 • Number of events 1 • 6 months from baseline

Other adverse events

Measure	Weight Loss Lifestyle Counseling n=47 participants at risk 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.	Weight Stable Lifestyle Counseling n=49 participants at risk 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.
Gastrointestinal disorders Digestive	8.5% 4/47 • 6 months from baseline	4.1% 2/49 • 6 months from baseline
Musculoskeletal and connective tissue disorders Musculoskeletal	2.1% 1/47 • 6 months from baseline	6.1% 3/49 • 6 months from baseline

Additional Information

Kristen Beavers

Wake Forest University

Phone: 3367585855

Email: beaverkm@wfu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place