Trial Outcomes & Findings for Food Intake Response to Short-Term Modifications of Metabolism in Humans (NCT NCT02939404)
NCT ID: NCT02939404
Last Updated: 2025-07-04
Results Overview
Energy expenditure (EE) as measured during 24 hours in a whole-room calorimeter
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)
Results posted on
2025-07-04
Participant Flow
Participant milestones
| Measure |
Chamber at 19°C With Fixed Diet First
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
Chamber at 24°C, Fixed Diet
STARTED
|
24
|
30
|
|
Chamber at 24°C, Fixed Diet
COMPLETED
|
19
|
27
|
|
Chamber at 24°C, Fixed Diet
NOT COMPLETED
|
5
|
3
|
|
Chamber at 24°C, ad Libitum Diet
STARTED
|
24
|
30
|
|
Chamber at 24°C, ad Libitum Diet
COMPLETED
|
19
|
27
|
|
Chamber at 24°C, ad Libitum Diet
NOT COMPLETED
|
5
|
3
|
|
Chamber at 19°C, Fixed Diet
STARTED
|
24
|
30
|
|
Chamber at 19°C, Fixed Diet
COMPLETED
|
19
|
27
|
|
Chamber at 19°C, Fixed Diet
NOT COMPLETED
|
5
|
3
|
|
Chamber at 19°C, ad Libitum Diet
STARTED
|
24
|
30
|
|
Chamber at 19°C, ad Libitum Diet
COMPLETED
|
19
|
27
|
|
Chamber at 19°C, ad Libitum Diet
NOT COMPLETED
|
5
|
3
|
|
Chamber at 24°C, Fasting
STARTED
|
24
|
30
|
|
Chamber at 24°C, Fasting
COMPLETED
|
19
|
27
|
|
Chamber at 24°C, Fasting
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Chamber at 19°C With Fixed Diet First
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
Chamber at 24°C, ad Libitum Diet
Adverse Event
|
2
|
1
|
|
Chamber at 24°C, ad Libitum Diet
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Food Intake Response to Short-Term Modifications of Metabolism in Humans
Baseline characteristics by cohort
| Measure |
Chamber at 19°C With Fixed Diet First
n=24 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=30 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)Energy expenditure (EE) as measured during 24 hours in a whole-room calorimeter
Outcome measures
| Measure |
Chamber at 19°C With Fixed Diet First
n=18 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=27 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
24-hour Energy Expenditure (kcal)
Chamber at 24°C, fixed diet
|
2256 kcal
Standard Deviation 393
|
2166 kcal
Standard Deviation 302
|
|
24-hour Energy Expenditure (kcal)
Chamber at 24°C, ad libitum diet
|
2563 kcal
Standard Deviation 422
|
2487 kcal
Standard Deviation 385
|
|
24-hour Energy Expenditure (kcal)
Chamber at 19°C, fixed diet
|
2271 kcal
Standard Deviation 360
|
2153 kcal
Standard Deviation 304
|
|
24-hour Energy Expenditure (kcal)
Chamber at 19°C, ad libitum diet
|
2552 kcal
Standard Deviation 418
|
2505 kcal
Standard Deviation 401
|
|
24-hour Energy Expenditure (kcal)
Chamber at 24°C, fasting
|
2135 kcal
Standard Deviation 337
|
1998 kcal
Standard Deviation 296
|
PRIMARY outcome
Timeframe: Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)Energy intake as measured during 24 hours in a whole-room calorimeter
Outcome measures
| Measure |
Chamber at 19°C With Fixed Diet First
n=18 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=27 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
24-hour Energy Intake (kcal)
Chamber at 24°C, fixed diet
|
3811 kcal
Standard Deviation 1140
|
3694 kcal
Standard Deviation 1503
|
|
24-hour Energy Intake (kcal)
Chamber at 24°C, ad libitum diet
|
4091 kcal
Standard Deviation 1054
|
4359 kcal
Standard Deviation 1404
|
|
24-hour Energy Intake (kcal)
Chamber at 19°C, fixed diet
|
4014 kcal
Standard Deviation 1136
|
4075 kcal
Standard Deviation 1587
|
|
24-hour Energy Intake (kcal)
Chamber at 19°C, ad libitum diet
|
4509 kcal
Standard Deviation 1255
|
4762 kcal
Standard Deviation 1610
|
|
24-hour Energy Intake (kcal)
Chamber at 24°C, fasting
|
3795 kcal
Standard Deviation 1223
|
4112 kcal
Standard Deviation 1406
|
SECONDARY outcome
Timeframe: Days 6 (Chamber at 24°C, fixed diet), 10(Chamber at 24°C, ad libitum diet), 14(Chamber at 19°C, fixed or ad libitum diet), 18(Chamber at 19°C, fixed or ad libitum diet), and 21(Chamber at 24°C, fasting)RQ, an approximation for the ratio of carbohydrate-to-fat oxidation rates, is measured while in the chamber
Outcome measures
| Measure |
Chamber at 19°C With Fixed Diet First
n=18 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=27 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
24- Hour Respiratory Quotient (RQ)
Chamber at 24°C, fixed diet
|
0.868 ratio
Standard Deviation 0.024
|
0.868 ratio
Standard Deviation 0.029
|
|
24- Hour Respiratory Quotient (RQ)
Chamber at 24°C, ad libitum diet
|
0.925 ratio
Standard Deviation 0.056
|
0.935 ratio
Standard Deviation 0.06
|
|
24- Hour Respiratory Quotient (RQ)
Chamber at 19°C, fixed diet
|
0.872 ratio
Standard Deviation 0.02
|
0.867 ratio
Standard Deviation 0.032
|
|
24- Hour Respiratory Quotient (RQ)
Chamber at 19°C, ad libitum diet
|
0.909 ratio
Standard Deviation 0.037
|
0.916 ratio
Standard Deviation 0.045
|
|
24- Hour Respiratory Quotient (RQ)
Chamber at 24°C, fasting
|
0.793 ratio
Standard Deviation 0.022
|
0.789 ratio
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)Plasma leptin (ng/ml)
Outcome measures
| Measure |
Chamber at 19°C With Fixed Diet First
n=18 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=27 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
Leptin
Chamber at 19°C, fixed diet
|
29.5 ng/mL
Standard Deviation 30.1
|
27.8 ng/mL
Standard Deviation 30.3
|
|
Leptin
Chamber at 24°C, fasting
|
18.3 ng/mL
Standard Deviation 19.9
|
16.6 ng/mL
Standard Deviation 22.1
|
|
Leptin
Chamber at 24°C, fixed diet
|
26.1 ng/mL
Standard Deviation 26.4
|
26.5 ng/mL
Standard Deviation 30.5
|
SECONDARY outcome
Timeframe: Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)Plasma secretin (ng/ml)
Outcome measures
| Measure |
Chamber at 19°C With Fixed Diet First
n=18 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=27 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
Secretin
(Chamber at 24°C, fixed diet
|
0.91 ng/mL
Standard Deviation 0.22
|
0.91 ng/mL
Standard Deviation 0.25
|
|
Secretin
(Chamber at 19°C, fixed diet
|
1.03 ng/mL
Standard Deviation 0.26
|
1.00 ng/mL
Standard Deviation 0.25
|
|
Secretin
(Chamber at 24°C, fasting
|
0.99 ng/mL
Standard Deviation 0.24
|
1.01 ng/mL
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)Plasma grehlin (pg/ml)
Outcome measures
| Measure |
Chamber at 19°C With Fixed Diet First
n=18 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=27 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
Ghrelin
Chamber at 24°C, fixed diet
|
502 pg/mL
Standard Deviation 254
|
644 pg/mL
Standard Deviation 274
|
|
Ghrelin
Chamber at 19°C, fixed diet
|
544 pg/mL
Standard Deviation 277
|
605 pg/mL
Standard Deviation 311
|
|
Ghrelin
Chamber at 24°C, fasting
|
575 pg/mL
Standard Deviation 293
|
581 pg/mL
Standard Deviation 304
|
SECONDARY outcome
Timeframe: Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)Plasma FGF-21 (pg/ml)
Outcome measures
| Measure |
Chamber at 19°C With Fixed Diet First
n=18 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=27 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
FGF-21
Chamber at 24°C, fixed diet
|
94 pg/mL
Standard Deviation 73
|
98 pg/mL
Standard Deviation 72
|
|
FGF-21
Chamber at 19°C, fixed diet
|
98 pg/mL
Standard Deviation 81
|
113 pg/mL
Standard Deviation 90
|
|
FGF-21
Chamber at 24°C, fasting
|
106 pg/mL
Standard Deviation 66
|
108 pg/mL
Standard Deviation 76
|
SECONDARY outcome
Timeframe: Days 6 (Chamber at 24°C, fixed diet), 14(Chamber at 19°C, fixed diet) or 18(Chamber at 19°C, fixed diet), and 21(Chamber at 24°C, fasting)Core body temperature measured in chamber
Outcome measures
| Measure |
Chamber at 19°C With Fixed Diet First
n=10 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=21 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
Core Body Temperature (C)
Chamber at 24°C, fixed diet
|
36.98 C
Standard Deviation 0.15
|
37.02 C
Standard Deviation 0.17
|
|
Core Body Temperature (C)
Chamber at 19°C, fixed diet
|
36.97 C
Standard Deviation 0.19
|
36.95 C
Standard Deviation 0.20
|
|
Core Body Temperature (C)
Chamber at 24°C, fasting
|
36.98 C
Standard Deviation 0.21
|
36.98 C
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: 6 monthsWeight change from baseline to 6 months
Outcome measures
| Measure |
Chamber at 19°C With Fixed Diet First
n=7 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=11 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
Weight Change at 6 Months
|
0.3 kg
Standard Deviation 5.6
|
-0.5 kg
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 12 monthsWeight change from baseline to 12 months
Outcome measures
| Measure |
Chamber at 19°C With Fixed Diet First
n=6 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=11 Participants
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
Weight Change at 12 Months
|
1.0 kg
Standard Deviation 8.9
|
-0.6 kg
Standard Deviation 8.9
|
Adverse Events
Chamber at 19°C With Fixed Diet First
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2. Chamber at 19°C, ad Libitum Diet First
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chamber at 19°C With Fixed Diet First
n=24 participants at risk
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, Chamber at 19°C with ad libitum diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
2. Chamber at 19°C, ad Libitum Diet First
n=30 participants at risk
Order of chambers will be Chamber at normal room temperature (24°C) with fixed eucaloric diet, Chamber at 24°C with ad libitum diet, Chamber at 19°C with ad libitum diet, Chamber at 19°C with fixed eucaloric diet, and Chamber at 24°C fasting.
Normal room temperature: 23.25 hours inside respiratory chamber with the temperature set to 24°C
Fixed diet: A diet that matches the participant's caloric needs
Ad libitum diet: Participants can eat as much as they want (self-select how much food they wish to eat)
|
|---|---|---|
|
Gastrointestinal disorders
Gastroesophageal reflux disease symptoms at Chamber at 24°C, fixed diet
|
8.3%
2/24 • Number of events 2 • 1 year
|
0.00%
0/30 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease symptoms at Chamber at 19°C, fixed diet
|
0.00%
0/24 • 1 year
|
3.3%
1/30 • Number of events 1 • 1 year
|
Additional Information
Douglas C. Chang, MD
Obesity & Diabetes Clinical Research Section, NIDDK
Phone: 602.200.5312
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place