Type 2 DiabetesNCT01161030
Almonds and Diabetes Management
A study testing Almonds in people with Type 2 Diabetes, run by Arizona State University.
Trial summary
This trial examined the impact of acute and chronic almond ingestion on indicators of glucose control (postprandial glycemia and hemoglobin A1c). Hypotheses: 1. Almonds will stimulate the secretion of GLP-1 in healthy adults and in adults with T2D The investigators were not able to demonstrate a relationship between… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Almonds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 12 subjects with diagnosed T2D for at least 1 year and 12 healthy individuals without T2D will be recruited for the acute almond trial.
- 24 subjects with diagnosed T2D for at least 1 year will be recruited for the chronic almond trial.
- Subjects from the campus population and nearby communities will be recruited to participate in these trials.
- Men and women must be willing to comply with the experimental protocol including the restriction of nut consumption:
- subjects recruited for the acute almond study must agree not to consume any nuts or nut butters for 1-week prior to and during the 2-week trial
- participants in the chronic almond study must agree not to consume nuts or nut butters more than 2 times per week during the 12 week trial.
- Participants must have a body mass index (BMI) from 20 to 35 kg/m2 and are aged 30 to 70 years.
- Subjects with T2D may take oral hyperglycemic agents.
Who cannot join
- Insulin use
- History of a peanut allergy
- Chronic or unresolved disease
- Current smoking habit
- Pregnant or lactating
- Medication use that may impact incretin secretion. [Incretins are gastrointestinal hormones secreted at meal-time.]
About this study
Official title: Almond Ingestion at Meal-time Reduces Postprandial Glycemia and Chronic Ingestion Reduces Hemoglobin A1c in Individuals With Well-controlled Type 2 Diabetes
This trial examined the impact of acute and chronic almond ingestion on indicators of glucose control (postprandial glycemia and hemoglobin A1c). Hypotheses:
- Almonds will stimulate the secretion of GLP-1 in healthy adults and in adults with T2D The investigators were not able to demonstrate a relationship between GLP-1 secretion and almond consumption. Individuals with T2D were characterized with significantly greater GLP-1 secretion than the non-diabetic control subjects.
- Acute ingestion of almonds will decrease the postprandial glycemia and insulinemic responses in healthy controls and in individuals with T2D The investigators data support the hypothesis: almond consumption by individuals with T2D did attenuate postprandial glycemia; however, almond consumption did not alter glycemia in non-diabetic control subjects
- Chronic almond ingestion for 12 weeks will reduce fasting glucose (FG) and A1c concentrations in individuals with T2D The investigators data demonstrated modest beneficial effect of almond consumption on A1c in individuals with T2D. Almond consumption was also associated with modest weight loss as compared to the control treatment (low fat cheese sticks).
- Conditions
- Type 2 Diabetes
- Being tested
- Almonds
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| almonds | Experimental | 1-oz raw almonds: 173 kcal, 4.6 g carbohydrate, 14.6 g fat Receives: Dietary Supplement: Almonds |
| Control | Placebo comparator | cheese stick Receives: Dietary Supplement: Almonds |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Johnston, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161030
- Sponsor's protocol ID
- almond1
- Status last verified
- Aug 2019
- First submitted
- 9 Jul 2010
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Almond Ingestion at Meal-time Reduces Postprandial Glycemia and Chronic Ingestion Reduces Hemoglobin A1c in Individuals With Well-controlled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01161030
- Acronym / sponsor ID
- almond1
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial examined the impact of acute and chronic almond ingestion on indicators of glucose control (postprandial glycemia and hemoglobin A1c). Hypotheses:
- Almonds will stimulate the secretion of GLP-1 in healthy adults and in adults with T2D The investigators were not able to demonstrate a relationship between GLP-1 secretion and almond consumption. Individuals with T2D were characterized with significantly greater GLP-1 secretion than the non-diabetic control subjects.
- Acute ingestion of almonds will decrease the postprandial glycemia and insulinemic responses in healthy controls and in individuals with T2D The investigators data support the hypothesis: almond consumption by individuals with T2D did attenuate postprandial glycemia; however, almond consumption did not alter glycemia in non-diabetic control subjects
- Chronic almond ingestion for 12 weeks will reduce fasting glucose (FG) and A1c concentrations in individuals with T2D The investigators data demonstrated modest beneficial effect of almond consumption on A1c in individuals with T2D. Almond consumption was also associated with modest weight loss as compared to the control treatment (low fat cheese sticks).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| almonds | Experimental | Dietary Supplement: Almonds1-oz raw almonds: 173 kcal, 4.6 g carbohydrate, 14.6 g fat |
| Control | Placebo comparator | Dietary Supplement: Almondscheese stick |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 12 subjects with diagnosed T2D for at least 1 year and 12 healthy individuals without T2D will be recruited for the acute almond trial.
- 24 subjects with diagnosed T2D for at least 1 year will be recruited for the chronic almond trial.
- Subjects from the campus population and nearby communities will be recruited to participate in these trials.
- Men and women must be willing to comply with the experimental protocol including the restriction of nut consumption:
- Participants must have a body mass index (BMI) from 20 to 35 kg/m2 and are aged 30 to 70 years.
Key exclusion criteria (6 listed)
- Insulin use
- History of a peanut allergy
- Chronic or unresolved disease
- Current smoking habit
- Pregnant or lactating
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 |
|---|---|---|
| Almonds | Dietary supplement | Control, almonds |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Almonds in people with Type 2 Diabetes, run by Arizona State University.
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 8 inclusion and 6 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 28 Aug 2019; AzTrials last refreshed its copy on 26 Oct 2026.