Back to resultsAlmond Butter and Fasting Glucose
Primary Purpose
Type2 Diabetes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Almond Butter
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes
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
Sites / Locations
- Penn State
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Almond Butter
No-snack Control
Arm Description
Participants will consume one ounce per day (~32 g) of almond butter as an evening snack (i.e., after dinner and before sleep).
Participants will consume nothing besides water after dinner/bed sleep.
Outcomes
Primary Outcome Measures
Fasting glucose
Measured by continuous glucose monitoring (interstitial glucose)
Secondary Outcome Measures
Glucose trends
Measured by continuous glucose monitoring (interstitial glucose)
Inhibitory control
Measured by smartphone-based cognitive task
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03826472
Brief Title
Almond Butter and Fasting Glucose
Official Title
Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
CGM devices will be blinded.
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Almond Butter
Arm Type
Experimental
Arm Description
Participants will consume one ounce per day (~32 g) of almond butter as an evening snack (i.e., after dinner and before sleep).
Arm Title
No-snack Control
Arm Type
No Intervention
Arm Description
Participants will consume nothing besides water after dinner/bed sleep.
Intervention Type
Other
Intervention Name(s)
Almond Butter
Intervention Description
Natural almond butter
Primary Outcome Measure Information:
Title
Fasting glucose
Description
Measured by continuous glucose monitoring (interstitial glucose)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Glucose trends
Description
Measured by continuous glucose monitoring (interstitial glucose)
Time Frame
2 weeks
Title
Inhibitory control
Description
Measured by smartphone-based cognitive task
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penny M Kris-Etherton, PhD, RDN
Organizational Affiliation
Penn State
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Almond Butter and Fasting Glucose
We'll reach out to this number within 24 hrs