Trial Outcomes & Findings for Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome (NCT NCT00852475)
NCT ID: NCT00852475
Last Updated: 2017-02-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
6 months from Baseline
Results posted on
2017-02-02
Participant Flow
Participant milestones
| Measure |
MUFA
Assignment to monounsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the MUFA MOVE! program
MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE! diet and exercise program
|
PUFA
Assignment to polyunsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the PUFA MOVE! program
PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
20
|
|
Overall Study
COMPLETED
|
23
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
MUFA
Assignment to monounsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the MUFA MOVE! program
MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE! diet and exercise program
|
PUFA
Assignment to polyunsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the PUFA MOVE! program
PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
MUFA
n=26 Participants
Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program
MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program
|
PUFA
n=20 Participants
Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program
PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program
|
Total
n=46 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
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Gender
Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Gender
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
20 participants
n=7 Participants
|
86 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months from BaselineOutcome measures
| Measure |
MUFA
n=23 Participants
Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program
MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program
|
PUFA
n=16 Participants
Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program
PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program
|
|---|---|---|
|
Weight Changes in Veterans With MetS.
|
-2.3 kg
Standard Error 0.99
|
-6.2 kg
Standard Error 1.2
|
SECONDARY outcome
Timeframe: 6 months from BaselineUltrasonographic imaging of the brachial artery (BART) was used to assess endothelium-dependent flow-mediated vasodilation (FMD) in participants at rest. To do this,the blood pressure cuff is inflated to 200 mm Hg and kept inflated for 5 minutes. On immediate release of the cuff, the brachial artery was imaged within 1 minute after cuff release.
Outcome measures
| Measure |
MUFA
n=23 Participants
Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program
MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program
|
PUFA
n=16 Participants
Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program
PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program
|
|---|---|---|
|
Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest .
|
0.19 percentage of change from baseline
Standard Error 0.29
|
1.5 percentage of change from baseline
Standard Error 0.38
|
Adverse Events
MUFA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PUFA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Miller, MD
Baltimore VAMC and University of Maryland Medical Center
Phone: 4103286299
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place