Trial Outcomes & Findings for Optimizing Body Composition for Function in Older Adults (NCT NCT00315146)
NCT ID: NCT00315146
Last Updated: 2018-08-28
Results Overview
Change in Appendicular Non-bone Lean Mass
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
88 participants
Primary outcome timeframe
Baseline visit (pre intervention) and 4month follow up (post intervention)
Results posted on
2018-08-28
Participant Flow
Starting in April 2006,144 participants underwent a medical screening. After further exclusion (n = 47) and declining to participate (n = 9), 88 participants (48 men, 40 women) were randomized to one of the four treatment groups.
Participant milestones
| Measure |
Hypocaloric Weight Loss Only
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day. The macronutrient goal for each individual was \~55-60% carbohydrates, \~15% protein, and \~25% fat.
|
Hypocaloric Weight Loss + Pioglitazone
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment.
|
Hypocaloric Weight-loss +Resistance Training
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching.
|
Hypocaloric Weight Loss + Resistance Training + Pioglitazone
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
19
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Body Composition for Function in Older Adults
Baseline characteristics by cohort
| Measure |
Hypocaloric Weight Loss Only
n=22 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day. The macronutrient goal for each individual was \~55-60% carbohydrates, \~15% protein, and \~25% fat.
|
Hypocaloric Weight Loss + Pioglitazone
n=22 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment.
|
Hypocaloric Weight-loss +Resistance Training
n=22 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching.
|
Hypocaloric Weight Loss + Resistance Training + Pioglitazone
n=22 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
71.0 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
69.9 years
STANDARD_DEVIATION 2.7 • n=4 Participants
|
70.6 years
STANDARD_DEVIATION 3.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
22 participants
n=4 Participants
|
88 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline visit (pre intervention) and 4month follow up (post intervention)Change in Appendicular Non-bone Lean Mass
Outcome measures
| Measure |
Hypocaloric Weight Loss Only
n=20 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day. The macronutrient goal for each individual was \~55-60% carbohydrates, \~15% protein, and \~25% fat.
|
Hypocaloric Weight Loss + Pioglitazone
n=19 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment.
|
Hypocaloric Weight-loss +Resistance Training
n=20 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching.
|
Hypocaloric Weight Loss + Resistance Training + Pioglitazone
n=22 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone.
|
|---|---|---|---|---|
|
Appendicular Non-bone Lean Mass
|
-2.53 kg
Interval -3.34 to -1.72
|
-2.49 kg
Interval -3.32 to -1.66
|
-2.04 kg
Interval -2.86 to -1.23
|
-1.45 kg
Interval -2.22 to -0.67
|
SECONDARY outcome
Timeframe: Baseline visit (pre intervention) and 4month follow up (post intervention)Outcome measures
| Measure |
Hypocaloric Weight Loss Only
n=20 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day. The macronutrient goal for each individual was \~55-60% carbohydrates, \~15% protein, and \~25% fat.
|
Hypocaloric Weight Loss + Pioglitazone
n=20 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment.
|
Hypocaloric Weight-loss +Resistance Training
n=19 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching.
|
Hypocaloric Weight Loss + Resistance Training + Pioglitazone
n=22 Participants
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone.
|
|---|---|---|---|---|
|
Lean Body Mass
|
-2.55 kg
Interval -4.31 to -0.79
|
-1.89 kg
Interval -3.99 to -0.021
|
-2.38 kg
Interval -4.48 to -0.28
|
-1.65 kg
Interval -3.67 to 0.37
|
Adverse Events
Hypocaloric Weight Loss Only
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Hypocaloric Weight Loss + Pioglitazone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hypocaloric Weight-loss +Resistance Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hypocaloric Weight Loss + Resistance Training + Pioglitazone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hypocaloric Weight Loss Only
n=22 participants at risk
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day. The macronutrient goal for each individual was \~55-60% carbohydrates, \~15% protein, and \~25% fat.
|
Hypocaloric Weight Loss + Pioglitazone
n=22 participants at risk
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment.
|
Hypocaloric Weight-loss +Resistance Training
n=22 participants at risk
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (\~100 kcal each) were allowed each day.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching.
|
Hypocaloric Weight Loss + Resistance Training + Pioglitazone
n=22 participants at risk
Two meal replacements per day (bars and shakes) were provided to all participants (containing \~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.
The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.
Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone.
|
|---|---|---|---|---|
|
Vascular disorders
Hospitalization for DVT
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization for brain tumor
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Surgical and medical procedures
Fainted during muscle biopsy procedure
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
Other adverse events
Adverse event data not reported
Additional Information
Stephen Kritchevsky
Wake Forest Universtiy Baptist Medical Center
Phone: 336-713-8548
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place