Type2 DiabetesPhase 2NCT03826472
Almond Butter and Fasting Glucose
A Phase 2 study testing Almond Butter in people with Type2 Diabetes, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Almond Butter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to 1 Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes
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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- Almond Butter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almond ButterOther
Natural almond butter
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Almond Butter |
| No-snack Control | No intervention | Participants will consume nothing besides water after dinner/bed sleep. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (2)
Glucose Trends
Overnight (12pm-4am) mean blood sugar values measured by continuous glucose monitoring (interstitial glucose)
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start8 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, RDN, Principal investigator, Penn State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826472
- Sponsor's protocol ID
- PKE AlmondButter
- Status last verified
- Apr 2024
- First submitted
- 30 Jan 2019
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03826472
- Acronym / sponsor ID
- PKE AlmondButter
- Conditions
- Type2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Posted 9 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond Butter | Experimental | Other: Almond ButterParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almond ButterNatural almond butter | Other | Almond Butter |
Primary outcome
Fasting Glucose Measured Using Continuous Glucose Monitoring
Time frame: 2 weeks
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 secondary outcomes
Glucose Trends
Time frame: 2 weeks
Inhibitory Control Task (Percent Correct)
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny M Kris-Etherton, PhD, RDN principal investigator
Penn State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Almond Butter in people with Type2 Diabetes, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Glucose Measured Using Continuous Glucose Monitoring (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.