Trial Outcomes & Findings for Almond Butter and Fasting Glucose (NCT NCT03826472)
NCT ID: NCT03826472
Last Updated: 2024-04-09
Results Overview
Fasting glucose measures how much glucose (sugar) is in a blood sample after an overnight fast. In this study, fasting glucose was measured by continuous glucose monitoring (interstitial glucose); fasting window identified through review of glucose monitoring data to be 4am-6am.
COMPLETED
PHASE2
10 participants
2 weeks
2024-04-09
Participant Flow
This was a crossover study, a total of 10 participants completed the study. Data from 1 participant was not used due a technology issue.
Participant milestones
| Measure |
Almond Butter-No Snack Control
First intervention:
Participants will consume one ounce per day (\~32 g) of almond butter as an evening snack (i.e., after dinner and before sleep).
Almond Butter: Natural almond butter
Second intervention:
Participants will consume nothing besides water after dinner/bed sleep.
|
No-snack Control-Almond Butter
First intervention:
Participants will consume nothing besides water after dinner/bed sleep.
Second intervention:
Participants will consume one ounce per day (\~32 g) of almond butter as an evening snack (i.e., after dinner and before sleep).
Almond Butter: Natural almond butter
|
|---|---|---|
|
First Intervention (1-week)
STARTED
|
5
|
5
|
|
First Intervention (1-week)
COMPLETED
|
5
|
5
|
|
First Intervention (1-week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1-week)
STARTED
|
5
|
5
|
|
Second Intervention (1-week)
COMPLETED
|
5
|
5
|
|
Second Intervention (1-week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Almond Butter-No Snack
n=5 Participants
First intervention:
Participants will consume one ounce per day (\~32 g) of almond butter as an evening snack (i.e., after dinner and before sleep).
Almond Butter: Natural almond butter
Second intervention:
Participants will consume nothing besides water after dinner/bed sleep.
|
No Snack-Almond Butter
n=5 Participants
First intervention:
Participants will consume nothing besides water after dinner/bed sleep.
Second intervention:
Participants will consume one ounce per day (\~32 g) of almond butter as an evening snack (i.e., after dinner and before sleep).
Almond Butter: Natural almond butter
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
58 years
n=5 Participants
|
58 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
|
Mean duration of diabetes
|
8.2 years
n=5 Participants
|
6.8 years
n=5 Participants
|
7.5 years
n=10 Participants
|
|
Home self-monitoring of blood glucose prior to study start
|
1 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=10 Participants
|
|
Medication use
|
3 participants
n=5 Participants
|
4 participants
n=5 Participants
|
7 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Adults with a diagnosis of type 2 diabetes, not on insulin therapy.
Fasting glucose measures how much glucose (sugar) is in a blood sample after an overnight fast. In this study, fasting glucose was measured by continuous glucose monitoring (interstitial glucose); fasting window identified through review of glucose monitoring data to be 4am-6am.
Outcome measures
| Measure |
Almond Butter
n=9 Participants
Participants instructed to consume study provided 2 tbsp of natural almond butter after dinner and before bed.
|
No-snack Control
n=9 Participants
Participants asked not to consume any food or beverages besides water after dinner.
|
|---|---|---|
|
Fasting Glucose Measured Using Continuous Glucose Monitoring
|
148.6 mg/dL
Interval 94.9 to 202.3
|
142.1 mg/dL
Interval 94.0 to 190.3
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 9 participants total; 9 analyzed in each group (crossover study)
Overnight (12pm-4am) mean blood sugar values measured by continuous glucose monitoring (interstitial glucose)
Outcome measures
| Measure |
Almond Butter
n=9 Participants
Participants instructed to consume study provided 2 tbsp of natural almond butter after dinner and before bed.
|
No-snack Control
n=9 Participants
Participants asked not to consume any food or beverages besides water after dinner.
|
|---|---|---|
|
Glucose Trends
|
147.7 mg/dL
Interval 92.6 to 202.8
|
142.2 mg/dL
Interval 91.8 to 191.0
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 9 participants total; 9 analyzed in each group (crossover study)
Go-NoGo task asked participants to press a button when a letter other than X was on screen and not press a button when X was present.
Outcome measures
| Measure |
Almond Butter
n=9 Participants
Participants instructed to consume study provided 2 tbsp of natural almond butter after dinner and before bed.
|
No-snack Control
n=9 Participants
Participants asked not to consume any food or beverages besides water after dinner.
|
|---|---|---|
|
Inhibitory Control Task (Percent Correct)
|
35.34 percentage correct
Standard Deviation 1.51
|
35.51 percentage correct
Standard Deviation 1.98
|
Adverse Events
Almond Butter
No-snack Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Emily Johnston
California Health Sciences University College of Osteopathic Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place