Glucose IntoleranceNCT05176197
Effects of Almonds on Glycemia in Adults With Elevated Hemoglobin A1c Concentrations
A study testing Almond in people with Glucose Intolerance and Glucose Metabolism Disorders (Including Diabetes Mellitus), run by Purdue University at 1 site in United States.
Trial summary
This study will examine the effects of regular almond consumption by individuals with elevated HbA1c on long-term glycemic control. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance, Glucose Metabolism Disorders (Including Diabetes Mellitus)
- What is being tested?
- Almond
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 30 May 2024
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HbA1c >5.7%
- BMI >20 kg/M^2
- Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same level for the duration of the trial.
- Healthy, good dentition
- No nut allergies
- >4.0 eating events per day
- >=1 low nutrient density snack/d
- No allergy to chocolate
Who cannot join
- HbA1c within normal range
- BMI <20 kg/M^2
- Nut allergies
- Smoker
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine the effects of regular almond consumption by individuals with elevated HbA1c on long-term glycemic control.
Read the detailed description
Globally, it is projected that 418 million people will have impaired glucose tolerance by 2025. In the US, an estimated 34 million Americans have diabetes and 88 million, 33% of adults, have pre-diabetes. Impaired glucose tolerance is now manifesting in young adults where 20% of those 12-18 years of age have prediabetes. The current prevalence of Type 2 diabetes is over 8%, but it is projected that up to a third of Americans will develop diabetes in their lifetime. Additionally, the total annual cost of diabetes is approximately $327 which accounts for 25% of all US health care costs. Moreover, the costs rose 60% from 2007 to 2017 and this trend is continuing.
Diet is the preferred approach for management for this diet-related chronic disorder. Accumulating evidence suggests almond consumption decreases postprandial glycemia and may evoke a second meal effect, especially when they are consumed at breakfast or as an afternoon snack, which may aid in long-term glycemic control. Additionally, almond consumption can decrease total and LDL cholesterol, resulting in lower peripheral insulin resistance and cardiometabolic complications from type 2 diabetes mellitus. However, there is mixed evidence on the effects of almond consumption on HbA1c, a clinically important endpoint that provides a reliable measure of long-term glycemia and is correlated with risk of complications from diabetes. Thus, the investigators hypothesize a beneficial effect of regular almond consumption on long-term glycemic control in individuals with elevated baseline HbA1c.
- Being tested
- Almond, Control
- Medical subject headings
- Glucose Intolerance, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondOther
Participants will consume almonds every day for 16 weeks.
ControlOther
Participants will consume pretzels every day for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Almond Group | Experimental | Participants will consume almonds every day for 16 weeks, but will not be allowed to consume any other nuts or nut products. Receives: Other: Almond |
| Control Group | Experimental | Participants will consume pretzels every day for 16 weeks, but will not be allowed to consume any other nuts or nut products. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: Baseline
Change in HbA1c
HbA1c % change
Measured: 16 weeks
Secondary outcomes (7)
Glucose response to a meal tolerance test
mg/dl
Measured: Baseline and week 16
Insulin response to a meal tolerance test
mmol/L
Measured: Baseline and week 16
Chronic glycemia
mg/dl
Measured: Baseline, week 8 and week 16
Food intake
kcal
Measured: Two days (one week day and one weekend day) at screening, week 8 and week 16.
Body weight
Kilograms (kg)
Measured: Screening, baseline, week 4, week 8, week 12, and week 16
Body composition
Percentage (%)
Measured: Baseline, week 16
Hedonic survey
mm on a VAS
Measured: Baseline, week 4, week 8, week 12. week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start9 Feb 2022
- Primary completion30 Jul 2023
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176197
- Sponsor's protocol ID
- 055-055
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Almonds on Glycemia in Adults With Elevated Hemoglobin A1c Concentrations
- ClinicalTrials.gov ID
- NCT05176197
- Acronym / sponsor ID
- 055-055
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 4 Jan 2022 (actual)
- 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 study will examine the effects of regular almond consumption by individuals with elevated HbA1c on long-term glycemic control.
Detailed description
Globally, it is projected that 418 million people will have impaired glucose tolerance by 2025. In the US, an estimated 34 million Americans have diabetes and 88 million, 33% of adults, have pre-diabetes. Impaired glucose tolerance is now manifesting in young adults where 20% of those 12-18 years of age have prediabetes. The current prevalence of Type 2 diabetes is over 8%, but it is projected that up to a third of Americans will develop diabetes in their lifetime. Additionally, the total annual cost of diabetes is approximately $327 which accounts for 25% of all US health care costs. Moreover, the costs rose 60% from 2007 to 2017 and this trend is continuing.
Diet is the preferred approach for management for this diet-related chronic disorder. Accumulating evidence suggests almond consumption decreases postprandial glycemia and may evoke a second meal effect, especially when they are consumed at breakfast or as an afternoon snack, which may aid in long-term glycemic control. Additionally, almond consumption can decrease total and LDL cholesterol, resulting in lower peripheral insulin resistance and cardiometabolic complications from type 2 diabetes mellitus. However, there is mixed evidence on the effects of almond consumption on HbA1c, a clinically important endpoint that provides a reliable measure of long-term glycemia and is correlated with risk of complications from diabetes. Thus, the investigators hypothesize a beneficial effect of regular almond consumption on long-term glycemic control in individuals with elevated baseline HbA1c.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond Group | Experimental | Other: AlmondParticipants will consume almonds every day for 16 weeks, but will not be allowed to consume any other nuts or nut products. |
| Control Group | Experimental | Other: ControlParticipants will consume pretzels every day for 16 weeks, but will not be allowed to consume any other nuts or nut products. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HbA1c >5.7%
- BMI >20 kg/M^2
- Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same level for the duration of the trial.
- Healthy, good dentition
- No nut allergies
Key exclusion criteria (5 listed)
- HbA1c within normal range
- BMI <20 kg/M^2
- Nut allergies
- Smoker
- Pregnant
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 |
|---|---|---|
| AlmondParticipants will consume almonds every day for 16 weeks. | Other | Almond Group |
| ControlParticipants will consume pretzels every day for 16 weeks. | Other | Control Group |
Primary outcome
HbA1c
Time frame: Baseline
Change in HbA1c
Time frame: 16 weeks
HbA1c % change
7 secondary outcomes
Glucose response to a meal tolerance test
Time frame: Baseline and week 16
Insulin response to a meal tolerance test
Time frame: Baseline and week 16
Chronic glycemia
Time frame: Baseline, week 8 and week 16
Food intake
Time frame: Two days (one week day and one weekend day) at screening, week 8 and week 16.
Body weight
Time frame: Screening, baseline, week 4, week 8, week 12, and week 16
Body composition
Time frame: Baseline, week 16
Hedonic survey
Time frame: Baseline, week 4, week 8, week 12. week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- 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.
Richard D Mattes, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond in people with Glucose Intolerance and Glucose Metabolism Disorders (Including Diabetes Mellitus), run by Purdue 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Dec 2023. 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.
Are results available for this study?
Results are not available in the source record.
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?
HbA1c (time frame: Baseline). The study lists 2 primary outcomes in all. 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 12 Dec 2023.