Almond Butter and Fasting Glucose
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedStudy Start
First participant enrolled
March 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedResults Posted
Study results publicly available
November 9, 2023
CompletedApril 9, 2024
April 1, 2024
12 months
January 30, 2019
October 4, 2021
April 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Glucose Trends
2 weeks
Inhibitory Control Task (Percent Correct)
2 weeks
Study Arms (2)
Almond Butter
EXPERIMENTALParticipants 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 INTERVENTIONParticipants will consume nothing besides water after dinner/bed sleep.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State
University Park, Pennsylvania, 16802, United States
Limitations and Caveats
This was a pilot study; interpretation of results is limited by small sample size and short study duration.
Results Point of Contact
- Title
- Emily Johnston
- Organization
- California Health Sciences University College of Osteopathic Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Penny M Kris-Etherton, PhD, RDN
Penn State
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2019
First Posted
February 1, 2019
Study Start
March 8, 2019
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
April 9, 2024
Results First Posted
November 9, 2023
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share