Trial Outcomes & Findings for Effects of CLA Supplements on Body Weight and Fat Oxidation (NCT NCT00204932)
NCT ID: NCT00204932
Last Updated: 2018-07-17
Results Overview
loss of fat mass, kg
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
6 months
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
Conjugated Linoleic Acid
4 grams per day of 78% CLA for 6 months
|
Placebo
4 grams per day of sunflower oil for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
22
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of CLA Supplements on Body Weight and Fat Oxidation
Baseline characteristics by cohort
| Measure |
Conjugated Linoleic Acid
n=24 Participants
3 grams per day for 7 months
|
Placebo
n=24 Participants
3 grams per day of sunflower oil for 7 months
|
Total
n=48 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
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 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
|
34 years
STANDARD_DEVIATION 8 • n=5 Participants
|
32 years
STANDARD_DEVIATION 7 • n=7 Participants
|
33 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsloss of fat mass, kg
Outcome measures
| Measure |
Conjugated Linoleic Acid
n=22 Participants
3 grams per day for 7 months
|
Placebo
n=18 Participants
3 grams per day of sunflower oil for 7 months
|
|---|---|---|
|
Fat Mass
|
-1.0 kg
Standard Deviation 2.2
|
0.7 kg
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 6 months24 hour respiratory gas analysis
Outcome measures
Outcome data not reported
Adverse Events
Conjugated Linoleic Acid
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
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 |
Conjugated Linoleic Acid
n=24 participants at risk
4 grams of 78% active CLA per day for 6 months
|
Placebo
n=24 participants at risk
4 grams per day of sunflower oil for 6 months
|
|---|---|---|
|
Blood and lymphatic system disorders
blood chemistry: soluble vascular cell adhesion
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
Additional Information
Dale Schoeller Principal Investigator
U Wisconsin-Madison
Phone: 608-262-1082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60