Trial Outcomes & Findings for Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults (NCT NCT00955903)
NCT ID: NCT00955903
Last Updated: 2017-09-05
Results Overview
Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
167 participants
Primary outcome timeframe
Baseline to 1 year
Results posted on
2017-09-05
Participant Flow
3 participants were subsequently diagnosed with cancer after enrollment and thus disqualified from continuing in the trial. They were dropped from the analysis.
Participant milestones
| Measure |
Weight Loss
Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet
|
Control
Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions
|
Weight Maintenance
Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
54
|
55
|
|
Overall Study
COMPLETED
|
49
|
51
|
48
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Baseline characteristics by cohort
| Measure |
Weight Loss
n=55 Participants
Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet
|
Control
n=54 Participants
Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions
|
Weight Maintenance
n=55 Participants
Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
69.9 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
70.3 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
54 participants
n=7 Participants
|
55 participants
n=5 Participants
|
164 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 yearVisceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year
Outcome measures
| Measure |
Weight Loss
n=55 Participants
Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet
|
Control
n=54 Participants
Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions
|
Weight Maintenance
n=55 Participants
Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet
|
|---|---|---|---|
|
Change in Abdominal Fat Mass
|
-192.6 Cubic cm
Standard Deviation 185.2
|
-21.9 Cubic cm
Standard Deviation 173.7
|
-275 Cubic cm
Standard Deviation 189.2
|
SECONDARY outcome
Timeframe: Baseline to 1 yearWe are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year
Outcome measures
| Measure |
Weight Loss
n=55 Participants
Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet
|
Control
n=54 Participants
Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions
|
Weight Maintenance
n=55 Participants
Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet
|
|---|---|---|---|
|
Cardiometabolic Risk Factors
|
-7.2 mg/dL
Standard Deviation 2.8
|
1.2 mg/dL
Standard Deviation 2.5
|
-1.2 mg/dL
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline to 1 yearThe change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year
Outcome measures
| Measure |
Weight Loss
n=55 Participants
Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet
|
Control
n=54 Participants
Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions
|
Weight Maintenance
n=55 Participants
Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet
|
|---|---|---|---|
|
Weight Change/Maintenance
|
-3.9 Kg
Standard Deviation 0.7
|
-1.3 Kg
Standard Deviation 0.7
|
-0.9 Kg
Standard Deviation 0.7
|
Adverse Events
Weight Loss
Serious events: 8 serious events
Other events: 36 other events
Deaths: 0 deaths
Control
Serious events: 11 serious events
Other events: 36 other events
Deaths: 0 deaths
Weight Maintenance
Serious events: 12 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Weight Loss
n=55 participants at risk
Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet
|
Control
n=54 participants at risk
Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions
|
Weight Maintenance
n=55 participants at risk
Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint surgery
|
1.8%
1/55 • Number of events 1
|
5.6%
3/54 • Number of events 3
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Chest pain
|
0.00%
0/55
|
0.00%
0/54
|
1.8%
1/55 • Number of events 1
|
|
Renal and urinary disorders
Urinary symptoms
|
0.00%
0/55
|
5.6%
3/54 • Number of events 3
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Heart rate and blood pressure abnormalities
|
1.8%
1/55 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Surgical and medical procedures
Complications related to surgery
|
1.8%
1/55 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
5.5%
3/55 • Number of events 3
|
|
Nervous system disorders
Pain
|
3.6%
2/55 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Broken bone
|
3.6%
2/55 • Number of events 2
|
0.00%
0/54
|
3.6%
2/55 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/55
|
3.7%
2/54 • Number of events 2
|
3.6%
2/55 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
1.8%
1/55 • Number of events 1
|
0.00%
0/54
|
0.00%
0/55
|
Other adverse events
| Measure |
Weight Loss
n=55 participants at risk
Participants receive Exercise Only and Reduced Calorie Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Reduced Calorie Diet: Participants will follow a reduced calorie diet
|
Control
n=54 participants at risk
Participants receive Exercise Only Intervention
Exercise Only: Participants will participate in supervised exercise sessions
|
Weight Maintenance
n=55 participants at risk
Participants receive Exercise Only and a Weight Maintenance Diet Interventions
Exercise Only: Participants will participate in supervised exercise sessions
Weight Maintenance Diet: Participants will follow a weight maintenance diet
|
|---|---|---|---|
|
Cardiac disorders
Cardiovascular
|
14.5%
8/55 • Number of events 8
|
25.9%
14/54 • Number of events 14
|
18.2%
10/55 • Number of events 10
|
|
Gastrointestinal disorders
Gastrointestinal
|
21.8%
12/55 • Number of events 12
|
11.1%
6/54 • Number of events 6
|
21.8%
12/55 • Number of events 12
|
|
General disorders
General, Constitutional
|
7.3%
4/55 • Number of events 4
|
5.6%
3/54 • Number of events 3
|
16.4%
9/55 • Number of events 9
|
|
Renal and urinary disorders
Genitourinary
|
1.8%
1/55 • Number of events 1
|
9.3%
5/54 • Number of events 5
|
5.5%
3/55 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle and bone issues
|
61.8%
34/55 • Number of events 34
|
64.8%
35/54 • Number of events 35
|
63.6%
35/55 • Number of events 35
|
|
Nervous system disorders
Nervous system
|
14.5%
8/55 • Number of events 8
|
13.0%
7/54 • Number of events 7
|
12.7%
7/55 • Number of events 7
|
|
Psychiatric disorders
Psychiatric and mood changes
|
9.1%
5/55 • Number of events 5
|
7.4%
4/54 • Number of events 4
|
7.3%
4/55 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place