Trial Outcomes & Findings for CALERIE: Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy (NCT NCT00427193)
NCT ID: NCT00427193
Last Updated: 2022-03-16
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
238 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2022-03-16
Participant Flow
238 Participants were eligible, 18 participants withdrew prior to randomization, 220 participants were randomized to the study, and 2 participants withdrew prior to initiating the intervention.
Participant milestones
| Measure |
Caloric Restriction (CR)
25% caloric restriction
Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
|
Ad Libitum
Ad libitum energy intake
Control: Participants continue their current diet for 24 months
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
75
|
|
Overall Study
COMPLETED
|
117
|
71
|
|
Overall Study
NOT COMPLETED
|
26
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CALERIE: Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy
Baseline characteristics by cohort
| Measure |
Caloric Restriction (CR)
n=143 Participants
25% caloric restriction
Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
|
Ad Libitum
n=75 Participants
Ad libitum energy intake
Control: Participants continue their current diet for 24 months
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
111 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsOutcome measures
| Measure |
Caloric Restriction (CR)
n=143 Participants
25% caloric restriction
Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
|
Ad Libitum
n=75 Participants
Ad libitum energy intake
Control: Participants continue their current diet for 24 months
|
|---|---|---|
|
Change in Core Body Temperature, Baseline to 12 Months
|
-0.05 degrees Celsius
Standard Deviation 0.02
|
-0.03 degrees Celsius
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: Baseline to 24 monthsOutcome measures
| Measure |
Caloric Restriction (CR)
n=143 Participants
25% caloric restriction
Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
|
Ad Libitum
n=75 Participants
Ad libitum energy intake
Control: Participants continue their current diet for 24 months
|
|---|---|---|
|
Change in Core Temperature, Baseline to 24 Months
|
-0.05 degrees Celsius
Standard Deviation 0.02
|
-0.02 degrees Celsius
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsOutcome measures
| Measure |
Caloric Restriction (CR)
n=143 Participants
25% caloric restriction
Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
|
Ad Libitum
n=75 Participants
Ad libitum energy intake
Control: Participants continue their current diet for 24 months
|
|---|---|---|
|
Change in Resting Metabolic Rate (RMR) Corrected for Changes in Body Composition, Baseline to 12 Months
|
-83 Kcal/day
Standard Deviation 10
|
-1 Kcal/day
Standard Deviation 13
|
PRIMARY outcome
Timeframe: Baseline, 24 monthsOutcome measures
| Measure |
Caloric Restriction (CR)
n=143 Participants
25% caloric restriction
Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
|
Ad Libitum
n=75 Participants
Ad libitum energy intake
Control: Participants continue their current diet for 24 months
|
|---|---|---|
|
Change in Resting Metabolic Rate (RMR) Corrected for Changes in Body Composition
|
-71 Kcal/day
Standard Deviation 12
|
-7 Kcal/day
Standard Deviation 16
|
SECONDARY outcome
Timeframe: change baseline to 12 monthsOutcome measures
| Measure |
Caloric Restriction (CR)
n=143 Participants
25% caloric restriction
Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
|
Ad Libitum
n=75 Participants
Ad libitum energy intake
Control: Participants continue their current diet for 24 months
|
|---|---|---|
|
Change in Tumor Necrosis Factor-α (TNF-α), Baseline to 12 Months
|
-0.30 pg/mL
Standard Deviation 0.09
|
-0.34 pg/mL
Standard Deviation 0.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change 0 to 24 monthsDifference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) was determined for the whole body.
Outcome measures
| Measure |
Caloric Restriction (CR)
n=143 Participants
25% caloric restriction
Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
|
Ad Libitum
n=75 Participants
Ad libitum energy intake
Control: Participants continue their current diet for 24 months
|
|---|---|---|
|
Change in Fat Mass
|
-6.1 kg
Standard Deviation 0.22
|
-0.2 kg
Standard Deviation 0.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 monthsDifference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) was determined for the whole body.
Outcome measures
| Measure |
Caloric Restriction (CR)
n=143 Participants
25% caloric restriction
Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
|
Ad Libitum
n=75 Participants
Ad libitum energy intake
Control: Participants continue their current diet for 24 months
|
|---|---|---|
|
Change in Fat Mass
|
-6.1 Kg
Standard Deviation 0.22
|
-0.3 Kg
Standard Deviation 0.28
|
Adverse Events
Caloric Restriction (CR)
Serious events: 1 serious events
Other events: 136 other events
Deaths: 0 deaths
Ad Libitum
Serious events: 7 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caloric Restriction (CR)
n=143 participants at risk
25% caloric restriction
Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
|
Ad Libitum
n=75 participants at risk
Ad libitum energy intake
Control: Participants continue their current diet for 24 months
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
spontaneous miscarriage
|
0.70%
1/143 • Number of events 1 • 0 to 24 months
|
0.00%
0/75 • 0 to 24 months
|
|
Injury, poisoning and procedural complications
pneumothorax
|
0.00%
0/143 • 0 to 24 months
|
1.3%
1/75 • Number of events 1 • 0 to 24 months
|
|
Reproductive system and breast disorders
leiomyoma
|
0.00%
0/143 • 0 to 24 months
|
1.3%
1/75 • Number of events 1 • 0 to 24 months
|
|
Musculoskeletal and connective tissue disorders
scoliosis
|
0.00%
0/143 • 0 to 24 months
|
1.3%
1/75 • Number of events 1 • 0 to 24 months
|
|
Musculoskeletal and connective tissue disorders
spinal osteoarthritis
|
0.00%
0/143 • 0 to 24 months
|
1.3%
1/75 • Number of events 1 • 0 to 24 months
|
|
Gastrointestinal disorders
intestinal abscess
|
0.00%
0/143 • 0 to 24 months
|
1.3%
1/75 • Number of events 1 • 0 to 24 months
|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.00%
0/143 • 0 to 24 months
|
1.3%
1/75 • Number of events 1 • 0 to 24 months
|
|
Vascular disorders
atrial septal defect
|
0.00%
0/143 • 0 to 24 months
|
1.3%
1/75 • Number of events 1 • 0 to 24 months
|
Other adverse events
| Measure |
Caloric Restriction (CR)
n=143 participants at risk
25% caloric restriction
Caloric Restriction (CR): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
|
Ad Libitum
n=75 participants at risk
Ad libitum energy intake
Control: Participants continue their current diet for 24 months
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
16.1%
23/143 • Number of events 43 • 0 to 24 months
|
10.7%
8/75 • Number of events 17 • 0 to 24 months
|
|
Reproductive system and breast disorders
dysmenorrhea
|
21.0%
30/143 • Number of events 78 • 0 to 24 months
|
14.7%
11/75 • Number of events 31 • 0 to 24 months
|
|
General disorders
dizziness
|
6.3%
9/143 • Number of events 48 • 0 to 24 months
|
13.3%
10/75 • Number of events 14 • 0 to 24 months
|
|
Metabolism and nutrition disorders
diarrhea
|
14.0%
20/143 • Number of events 27 • 0 to 24 months
|
13.3%
10/75 • Number of events 16 • 0 to 24 months
|
|
General disorders
nasal congestion
|
13.3%
19/143 • Number of events 28 • 0 to 24 months
|
6.7%
5/75 • Number of events 14 • 0 to 24 months
|
|
General disorders
constipation
|
12.6%
18/143 • Number of events 44 • 0 to 24 months
|
6.7%
5/75 • Number of events 11 • 0 to 24 months
|
|
General disorders
toothache
|
4.2%
6/143 • Number of events 21 • 0 to 24 months
|
6.7%
5/75 • Number of events 12 • 0 to 24 months
|
|
Musculoskeletal and connective tissue disorders
muscle strain
|
2.1%
3/143 • Number of events 16 • 0 to 24 months
|
4.0%
3/75 • Number of events 4 • 0 to 24 months
|
|
Infections and infestations
gastrointestinal virus
|
9.1%
13/143 • Number of events 16 • 0 to 24 months
|
6.7%
5/75 • Number of events 5 • 0 to 24 months
|
|
General disorders
pain
|
8.4%
12/143 • Number of events 20 • 0 to 24 months
|
6.7%
5/75 • Number of events 10 • 0 to 24 months
|
|
General disorders
rash
|
6.3%
9/143 • Number of events 9 • 0 to 24 months
|
1.3%
1/75 • Number of events 1 • 0 to 24 months
|
|
Infections and infestations
urinary tract infection
|
2.8%
4/143 • Number of events 11 • 0 to 24 months
|
5.3%
4/75 • Number of events 6 • 0 to 24 months
|
|
Blood and lymphatic system disorders
anemia
|
24.5%
35/143 • Number of events 99 • 0 to 24 months
|
22.7%
17/75 • Number of events 34 • 0 to 24 months
|
|
Musculoskeletal and connective tissue disorders
Excessive bone loss
|
2.1%
3/143 • Number of events 3 • 0 to 24 months
|
0.00%
0/75 • 0 to 24 months
|
Additional Information
William E. Kraus, Director of Clinical Research, Duke Center for Living
Duke University Medical Center
Phone: 919-681-6733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place