Trial Outcomes & Findings for Walnuts to Achieve Lasting NUTrition to Prevent Diabetes (NCT NCT03334175)
NCT ID: NCT03334175
Last Updated: 2020-09-02
Results Overview
Number of participants recruited and retained
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-09-02
Participant Flow
Participant milestones
| Measure |
Walnuts Now
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
|
Walnuts Later
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Walnuts Now
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
|
Walnuts Later
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Walnuts to Achieve Lasting NUTrition to Prevent Diabetes
Baseline characteristics by cohort
| Measure |
Walnuts Now
n=8 Participants
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
|
Walnuts Later
n=10 Participants
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
n=5 Participants
|
57.1 years
n=7 Participants
|
56.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Fasting glucose
|
109.5 mg/dL
STANDARD_DEVIATION 24.6 • n=5 Participants
|
106 mg/dL
STANDARD_DEVIATION 11.5 • n=7 Participants
|
107.6 mg/dL
STANDARD_DEVIATION 17.9 • n=5 Participants
|
|
Hemoglobin A1c
|
5.8 percentage of Hemoglobin A1c
STANDARD_DEVIATION 0.8 • n=5 Participants
|
5.9 percentage of Hemoglobin A1c
STANDARD_DEVIATION 0.3 • n=7 Participants
|
5.9 percentage of Hemoglobin A1c
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Body Mass Index
|
30.4 kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
35.6 kg/m^2
STANDARD_DEVIATION 5.9 • n=7 Participants
|
33 kg/m^2
STANDARD_DEVIATION 5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumber of participants recruited and retained
Outcome measures
| Measure |
Walnuts Now
n=8 Participants
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
|
Walnuts Later
n=10 Participants
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
|
|---|---|---|
|
Number of Participants Recruited and Retained
|
8 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Adherence was not measured in the control group who did not receive the walnut supplement.
Adherence to the intervention was determined through daily food diaries. Participants detailed daily consumption of the walnut supplement on a calendar provided at the outset of the study. Percentage was determined as number of days consuming supplement over 84 days total.
Outcome measures
| Measure |
Walnuts Now
n=8 Participants
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
|
Walnuts Later
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
|
|---|---|---|
|
Adherence to the Intervention
|
74.7 percentage of days
Interval 47.0 to 93.0
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Palatability was not measured in the control group who did not receive the walnut supplement intervention.
Palatability was measured using a visual analog scale, the scale range is 0-100, with 100 being the "Most Pleasant."
Outcome measures
| Measure |
Walnuts Now
n=8 Participants
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
|
Walnuts Later
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
|
|---|---|---|
|
Palatability of Supplement
|
87 score on a scale
Interval 70.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 0 weeks and 12 weeksPopulation: The "Walnuts Later" group did not complete the food frequency questionnaire required to assess change in diet quality. As the primary outcome was feasibility of recruitment and retention, we chose to analyze diet quality data only in those participants who provided these data.
Change in diet quality measured by Healthy Eating Index-2010 Score (0 - 100). Higher scores indicate better diet quality.
Outcome measures
| Measure |
Walnuts Now
n=8 Participants
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
|
Walnuts Later
n=6 Participants
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
|
|---|---|---|
|
Change in Diet Quality
|
2.1 score on a scale
Standard Deviation 11.9
|
2.9 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 0 weeks and 12 weeksChange in fasting glucose
Outcome measures
| Measure |
Walnuts Now
n=8 Participants
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
|
Walnuts Later
n=9 Participants
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
|
|---|---|---|
|
Fasting Glucose
|
-4.75 mg/dL
Standard Deviation 9.8
|
1.2 mg/dL
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 0 weeks and 12 weeksChange in percentage of Hemoglobin A1c
Outcome measures
| Measure |
Walnuts Now
n=8 Participants
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
|
Walnuts Later
n=9 Participants
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
|
|---|---|---|
|
Change in Hemoglobin A1c
|
-0.05 percentage of A1c
Standard Deviation 0.13
|
-0.08 percentage of A1c
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: 0 weeks and 12 weeksChange in low density lipoprotein levels from baseline to 12 weeks
Outcome measures
| Measure |
Walnuts Now
n=8 Participants
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
|
Walnuts Later
n=9 Participants
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
|
|---|---|---|
|
Change in Low Density Lipoprotein Levels
|
-8.4 mg/dL
Standard Deviation 15.5
|
-0.5 mg/dL
Standard Deviation 13.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 weeks and 12 weeksPlasma metabolomics performed as an exploratory outcome for all participants. This outcome represents number of participants who had a successful blood draw at both baseline and 12 weeks sent to the laboratory with usable data recovered.
Outcome measures
| Measure |
Walnuts Now
n=8 Participants
Will receive and be instructed to consume 1-oz individually wrapped daily walnut supplement packages for 12 weeks during intervention.
Walnuts: 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
|
Walnuts Later
n=9 Participants
Will receive diet and exercise guidance at beginning of study. At end of study, will receive 12 weeks of a walnut supply to be consumed at their discretion after the study is complete.
|
|---|---|---|
|
Number of Participants Who Had Plasma Metabolomics Performed
|
8 Participants
|
9 Participants
|
Adverse Events
Walnuts Now
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Walnuts Later
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place