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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almond Butter | Experimental | Participants will consume one ounce per day (~32 g) of almond butter as an evening snack (i.e., after dinner and before sleep). |
|
| No-snack Control | No Intervention | Participants will consume nothing besides water after dinner/bed sleep. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almond Butter | Other | Natural almond butter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Trends | Overnight (12pm-4am) mean blood sugar values measured by continuous glucose monitoring (interstitial glucose) | 2 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Penny M Kris-Etherton, PhD, RDN | Penn State | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State | University Park | Pennsylvania | 16802 | United States |
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This was a crossover study, a total of 10 participants completed the study. Data from 1 participant was not used due a technology issue.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1-week) |
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| Second Intervention (1-week) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Adults with a diagnosis of type 2 diabetes, not on insulin therapy. | Posted | Mean | 95% Confidence Interval | mg/dL | 2 weeks |
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All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Almond Butter | 2 tbsp of natural almond butter measured out and provided by metabolic kitchen to be consumed after dinner and before bed |
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This was a pilot study; interpretation of results is limited by small sample size and short study duration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Johnston | California Health Sciences University College of Osteopathic Medicine | 9737685888 | eajohnst@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2022 | Sep 29, 2022 | Prot_SAP_002.pdf |
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| 2 weeks |
| NOT COMPLETED |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Mean duration of diabetes | Mean | Full Range | years |
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| Home self-monitoring of blood glucose prior to study start | Count of Participants | Participants |
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| Medication use | Number | participants |
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Participants asked not to consume any food or beverages besides water after dinner.
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| Secondary | Glucose Trends | Overnight (12pm-4am) mean blood sugar values measured by continuous glucose monitoring (interstitial glucose) | 9 participants total; 9 analyzed in each group (crossover study) | Posted | Mean | 95% Confidence Interval | mg/dL | 2 weeks |
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| 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. | 9 participants total; 9 analyzed in each group (crossover study) | Posted | Mean | Standard Deviation | percentage correct | 2 weeks |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | No-snack Control | Participants asked not to consume any food or beverage besides water after dinner (unless medically necessary) | 0 | 0 | 0 | 0 | 0 | 0 |
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