Type2 Diabetes
Conditions
Brief summary
A two-period randomized crossover study will be conducted to determine the effect of almond butter as an evening snack on fasting blood glucose in adults with type 2 diabetes, not taking insulin.
Detailed description
Control of fasting blood glucose is a challenge for many individuals with diabetes. Researchers want to better understand how a nighttime snack can affect morning fasting blood glucose. A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 1 week. During the almond butter treatment, participants will consume 2 tbsp of almond butter per day as an evening snack. The control treatments will be a no-snack control. Fasting blood glucose, as well as glucose trends, will be measured using Continuous Glucose Monitor (CGM). Participants will also be asked to take simple cognitive tests on a study-provided smartphone each day of the study and report their daily food intake and physical activity.
Interventions
OTHERAlmond Butter
Natural almond butter
Sponsors
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Individuals with diagnosed type 2 diabetes * Not on insulin therapy * On stable does of oral antihyperglycemic agent (no dose change for 6 months) * Currently monitoring blood glucose at home via glucometer * Willing and able to adhere to study protocol
Exclusion criteria
* Individuals with type 1 diabetes, cardiovascular disease, kidney disease, liver disease, cancer or inflammatory conditions (e.g. GI disorders, rheumatoid arthritis) * Women who are pregnant, breastfeeding, or have been pregnant within the last 6 months or breastfeeding within the last 6 weeks * Individuals who smoke or use tobacco products * Use of insulin therapy or sulfonylurea medications * Allergy to any tree nut * Liver or kidney disease * Allergy to Dexcom CGM adhesive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Glucose Measured Using Continuous Glucose Monitoring | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Trends | 2 weeks | Overnight (12pm-4am) mean blood sugar values measured by continuous glucose monitoring (interstitial glucose) |
| Inhibitory Control Task (Percent Correct) | 2 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
This was a crossover study, a total of 10 participants completed the study. Data from 1 participant was not used due a technology issue.
Participants by arm
| Arm | Count |
|---|---|
| Almond Butter-No Snack 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. | 5 |
| No Snack-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 | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | No Snack-Almond Butter | Total | Almond Butter-No Snack |
|---|---|---|---|
| Age, Continuous | 58 years | 58 years | 59 years |
| Home self-monitoring of blood glucose prior to study start | 5 Participants | 6 Participants | 1 Participants |
| Mean duration of diabetes | 6.8 years | 7.5 years | 8.2 years |
| Medication use | 4 participants | 7 participants | 3 participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Fasting Glucose Measured Using Continuous Glucose Monitoring
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.
Time frame: 2 weeks
Population: Adults with a diagnosis of type 2 diabetes, not on insulin therapy.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Almond Butter | Fasting Glucose Measured Using Continuous Glucose Monitoring | 148.6 mg/dL |
| No-snack Control | Fasting Glucose Measured Using Continuous Glucose Monitoring | 142.1 mg/dL |
Secondary
Glucose Trends
Overnight (12pm-4am) mean blood sugar values measured by continuous glucose monitoring (interstitial glucose)
Time frame: 2 weeks
Population: 9 participants total; 9 analyzed in each group (crossover study)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Almond Butter | Glucose Trends | 147.7 mg/dL |
| No-snack Control | Glucose Trends | 142.2 mg/dL |
Secondary
Inhibitory Control Task (Percent Correct)
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.
Time frame: 2 weeks
Population: 9 participants total; 9 analyzed in each group (crossover study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Almond Butter | Inhibitory Control Task (Percent Correct) | 35.34 percentage correct | Standard Deviation 1.51 |
| No-snack Control | Inhibitory Control Task (Percent Correct) | 35.51 percentage correct | Standard Deviation 1.98 |