Trial Outcomes & Findings for The Metabolic Effects of Short-term Walnut Consumption in Subjects With the Metabolic Syndrome (NCT NCT00525629)
NCT ID: NCT00525629
Last Updated: 2017-12-15
Results Overview
HOMA-IR (homeostatic model assessment of insulin resistance) given in units as it is a ratio equation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
4 days
Results posted on
2017-12-15
Participant Flow
Participant milestones
| Measure |
Walnut Diet First, Then Control Diet
patients were asked to consume 48g of walnuts per day
|
Control Diet First, Then Walnut di
patients were asked to consume an isocaloric Diet with no Nuts
|
|---|---|---|
|
First Intervention
STARTED
|
20
|
20
|
|
First Intervention
COMPLETED
|
15
|
15
|
|
First Intervention
NOT COMPLETED
|
5
|
5
|
|
Washout
STARTED
|
15
|
15
|
|
Washout
COMPLETED
|
15
|
15
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
15
|
15
|
|
Second Intervention
COMPLETED
|
0
|
0
|
|
Second Intervention
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Metabolic Effects of Short-term Walnut Consumption in Subjects With the Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
All Patients
n=40 Participants
All patients received both interventions and are included in this group analysis
|
|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
|
Body Mass Index
|
37.1 kg/m^2
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Total Cholesterol
|
207 mg/dL
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Triglycerides
|
199.2 mg/dL
STANDARD_DEVIATION 22.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 daysHOMA-IR (homeostatic model assessment of insulin resistance) given in units as it is a ratio equation.
Outcome measures
| Measure |
Walnut Diet
n=30 Participants
48 Grams of Walnuts Daily
Walnuts: 48 Grams of Walnuts Daily
|
Control Diet
n=30 Participants
Isocaloric Diet with No Walnuts
Control: Control Diet with No Walnuts
|
|---|---|---|
|
Insulin Resistance
|
6.06 HOMA-IR index
Standard Deviation 3.78
|
5.72 HOMA-IR index
Standard Deviation 2.7
|
Adverse Events
Walnut Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Diet
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
Christos Mantzoros
Beth Israel Deaconess Medical Center
Phone: 617-667-8630
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place