Phase 2
N=10
Almond Butter and Fasting Glucose
Type2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03826472 ↗Enrolled (actual)
10
Serious AEs
—
Results posted
Nov 2023
Primary outcome: Primary: Fasting Glucose Measured Using Continuous Glucose Monitoring — 148.6; 142.1 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Almond Butter (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Penn State University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Glucose Measured Using Continuous Glucose Monitoring |
148.6; 142.1 | — |
| SECONDARY Glucose Trends |
147.7; 142.2 | — |
| SECONDARY Inhibitory Control Task (Percent Correct) |
35.34; 35.51 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03826472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.