Almond Butter and Fasting Glucose

The Pennsylvania State University (PENNSTATE)

Status and phase: Completed; Phase 2

Conditions: Type2 Diabetes

Treatments: Other: Almond Butter

Study type: Interventional

Funder types: Other

Identifiers

NCT03826472

PKE AlmondButter

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

10 participants in 2 patient groups

Almond Butter

Experimental group

Description:

Participants will consume one ounce per day (\~32 g) of almond butter as an evening snack (i.e., after dinner and before sleep).

Treatment:

Other: Almond Butter

No-snack Control

No Intervention group

Description:

Participants will consume nothing besides water after dinner/bed sleep.