Trial Outcomes & Findings for Effect of Caloric Restriction on Fat Oxidation in Obese Men and Women (Magellan II) (NCT NCT01616082)
NCT ID: NCT01616082
Last Updated: 2020-11-13
Results Overview
Measured with respiratory quotient obtained with indirect calorimetry Expected Results * Overweight and obese subjects will show a wide variation in fat oxidation in response to the low calorie diet * Approximately one-third of study participants will not meet target weight loss by four weeks * Following an overnight fast (prior to and during LCD) individuals that fail to meet the target weight loss will be characterized by decreased whole body fat oxidation and increased carbohydrate oxidation (measured by indirect calorimetry)
COMPLETED
NA
39 participants
Days 0, 14
2020-11-13
Participant Flow
Overweight/obese participant were recruited to the study to participate in a 28 day low calorie diet (LCD). After 28 days, participants were evaluated for whether they met their expected weight loss targets. If participants met their targets they continued the LCD for a further 28 days and are defined as Overweight/Obese With no Drug. If participants did not reach their weight loss target they continued with LCD with an addition of phentermine and are defined as Overweight/Obese With Phentermine
Participant milestones
| Measure |
Overweight/Obese With no Drug
After screening, overweight (obese subjects (BMI\<27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved.
Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. LCD period= continuous for 8 weeks.
|
Overweight/Obese With Phentermine
After screening, overweight/obese (BMI 27.0-≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved. Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects will be given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.
Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. LCD period = continuous for 8 weeks.
Phentermine: Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Caloric Restriction on Fat Oxidation in Obese Men and Women (Magellan II)
Baseline characteristics by cohort
| Measure |
Ovweight/Obese With no Drug
n=19 Participants
After screening, overweight (obese subjects (BMI \>27 - ≤40.0) subjects (n=35) will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved.
Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. The low calorie diet will begin, to continue for a period of 8 weeks.
|
Overweigh/Obese With Phentermine
n=20 Participants
After screening, obese subjects (BMI \>27- ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved. Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects will be given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.
Low Calorie Diet (LCD): See prior information.
Phentermine: See prior information.
Protection Against Risk: See prior information.
.
|
Total
n=39 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
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.3 years
n=5 Participants
|
43.6 years
n=7 Participants
|
42.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 0, 14Measured with respiratory quotient obtained with indirect calorimetry Expected Results * Overweight and obese subjects will show a wide variation in fat oxidation in response to the low calorie diet * Approximately one-third of study participants will not meet target weight loss by four weeks * Following an overnight fast (prior to and during LCD) individuals that fail to meet the target weight loss will be characterized by decreased whole body fat oxidation and increased carbohydrate oxidation (measured by indirect calorimetry)
Outcome measures
| Measure |
Overweight/Obese With no Drug
n=19 Participants
After screening, overweight (obese subjects (BMI \>27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved.
Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. The low calorie diet will begin, to continue for a period of 8 weeks.
|
Overweight/ Obese With Phentermine
n=18 Participants
After screening, obese subjects (BMI \>27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved. Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects will be given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.
Low Calorie Diet (LCD): See prior information.
Phentermine: See prior information.
Protection Against Risk: See prior information.
.
|
|---|---|---|
|
Change From Baseline Amount of Fat Oxidation at 14 Days
|
0.91 Fold change of RQ ratio
Standard Deviation 0.05
|
0.94 Fold change of RQ ratio
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: Days 0, 7, 14, 28, 49, 56Measured with respiratory quotient using indirect calorimetry Expected Results * Overweight and obese subjects will show a wide variation in fat oxidation in response to the low calorie diet * Approximately one-third of study participants will not meet target weight loss by four weeks * Following an overnight fast (prior to and during LCD) individuals that fail to meet the target weight loss will be charaterized by decreased whole body fat oxidation and increased carbohydrate oxidation (measured by indirect calorimetry)
Outcome measures
| Measure |
Overweight/Obese With no Drug
n=19 Participants
After screening, overweight (obese subjects (BMI \>27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved.
Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. The low calorie diet will begin, to continue for a period of 8 weeks.
|
Overweight/ Obese With Phentermine
n=18 Participants
After screening, obese subjects (BMI \>27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved. Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects will be given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.
Low Calorie Diet (LCD): See prior information.
Phentermine: See prior information.
Protection Against Risk: See prior information.
.
|
|---|---|---|
|
Fat Oxidation Rates at 1 Week Intervals
Day 0
|
0.867 Ratio
Standard Deviation 0.052
|
0.857 Ratio
Standard Deviation 0.059
|
|
Fat Oxidation Rates at 1 Week Intervals
Day 7
|
0.795 Ratio
Standard Deviation 0.041
|
0.787 Ratio
Standard Deviation 0.039
|
|
Fat Oxidation Rates at 1 Week Intervals
Day 14
|
0.791 Ratio
Standard Deviation 0.036
|
0.801 Ratio
Standard Deviation 0.041
|
|
Fat Oxidation Rates at 1 Week Intervals
Day 28
|
0.808 Ratio
Standard Deviation 0.034
|
0.811 Ratio
Standard Deviation 0.069
|
|
Fat Oxidation Rates at 1 Week Intervals
Day 49
|
0.800 Ratio
Standard Deviation 0.048
|
0.784 Ratio
Standard Deviation 0.044
|
|
Fat Oxidation Rates at 1 Week Intervals
Day 56
|
0.798 Ratio
Standard Deviation 0.048
|
0.785 Ratio
Standard Deviation 0.048
|
SECONDARY outcome
Timeframe: Days -7, -1, 14, 56Measured with magnetic resonance spectroscopy (MRS) Expected results * 1H-MRS can measure skeletal muscle (intramyocellular lipid) IMCL content with low test-retest variability * 1H-MRS can sensitively monitor reductions (or lack thereof) in skeletal muscle IMCL during caloric restriction * Reductions in IMCL will be higher in subjects with lower fasting respiratory quotients (RQ) at baseline/during LCD
Outcome measures
| Measure |
Overweight/Obese With no Drug
n=19 Participants
After screening, overweight (obese subjects (BMI \>27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved.
Low Calorie Diet (LCD): A Diet History Questionnaire will be completed, and the subjects will have dietary counseling and be provided shakes. The low calorie diet will begin, to continue for a period of 8 weeks.
|
Overweight/ Obese With Phentermine
n=18 Participants
After screening, obese subjects (BMI \>27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved. Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects will be given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.
Low Calorie Diet (LCD): See prior information.
Phentermine: See prior information.
Protection Against Risk: See prior information.
.
|
|---|---|---|
|
Soleus IMCL Content
Day -7
|
0.025 ratio of peak height of IMCL to water
Standard Deviation 0.010
|
0.032 ratio of peak height of IMCL to water
Standard Deviation 0.015
|
|
Soleus IMCL Content
Day 0
|
0.028 ratio of peak height of IMCL to water
Standard Deviation 0.014
|
0.034 ratio of peak height of IMCL to water
Standard Deviation 0.019
|
|
Soleus IMCL Content
Day 14
|
0.030 ratio of peak height of IMCL to water
Standard Deviation 0.011
|
0.034 ratio of peak height of IMCL to water
Standard Deviation 0.011
|
|
Soleus IMCL Content
Day 56
|
0.027 ratio of peak height of IMCL to water
Standard Deviation 0.014
|
0.034 ratio of peak height of IMCL to water
Standard Deviation 0.013
|
Adverse Events
Overweight/Obese With no Drug
Overwight/Obese With Phentermine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Steven R. Smith
Translational Research Institute for Metabolism and Diabetes
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place