Glucose ControlNUTSNCT07603739
Eating Almonds Before a Meal to Control Blood Sugar
A study testing Premeal almond ingestion in people with Glucose Control and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The goal of this study is to learn whether eating a small serving of almonds before meals can improve blood sugar control in adults who have early signs of problems with blood sugar regulation. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Control, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Precision Medicine
- What is being tested?
- Premeal almond ingestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 25-50 years
- Females over 40 years must have had a cycle in the last 6 months
- Body mass index (BMI) at least 18.5 and at most 55.0 kg/m2
- Impaired blood glucose by at least one of the following criteria:
- Fasting blood glucose at least 100 mg/dL (5.6 mmol/L) and less than 125 mg/dL (6.9 mmol/L)
- HbA1c at least 5.7% and less than 6.5%
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- Willing and able to comply with study foods
- Willing and able to ingest acetaminophen as part of study procedures
- Able to read, speak, and understand English
Who cannot join
- Weight change ≥5% in past 6 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study based on self-report
- Recent history within past 12 months of medical provider-diagnosed cardiovascular, renal, or liver disease that required treatment
- Current or past diagnosis of cancer (except skin cancer) in the last 5 years
- Current or past diagnosis of type 1 or type 2 diabetes
- Recent history within past 12 months of medical provider-diagnosed gastrointestinal or neurological disorders if not managed/stable for at least 3 months (with or without treatment)
- Recent history within past 12 months of medical provider-diagnosed psychiatric disorders including eating disorders or severe depression if not managed/stable for at least 3 months (with or without treatment)
Show all 11Show fewer
- Food allergies or other reasons preventing consumption of study foods
- Any glucose-lowering medication except biguanides (e.g., Metformin) if stable for at least 3 months or incretins (i.e., GLP-1RA-based) if stable for at least 3 months
- Current smoking or vaping or history of smoking or vaping in the past 6 months
- Binge and/or heavy drinking (i.e., >3 drinks on any given occasion and/or >7 drinks/week)
- Currently pregnant or planning to become pregnant or breastfeed in the next 3 months by self-report
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Kaja Falkenhain, PhD, 225-763-2558, kaja.falkenhain@pbrc.edu
About this study
Official title: Interindividual Variability in the Effect of Premeal Almond Supplementation on Glycemic Control - a Double Crossover Study
The goal of this study is to learn whether eating a small serving of almonds before meals can improve blood sugar control in adults who have early signs of problems with blood sugar regulation. The main questions it aims to answer are:
- Does eating almonds before a meal reduce the rise in blood sugar after eating?
- Do some people consistently benefit more than others from eating almonds before meals?
Read the detailed description
Large rises in blood sugar after eating are an early warning sign of type 2 diabetes, and simple dietary strategies may help lower this risk. This study aims to understand whether eating a small serving of almonds before meals can help reduce postprandial blood sugar levels in adults who are at increased risk for developing type 2 diabetes. Participants will take part in two phases of the study: one conducted in a research clinic to carefully measure short-term blood sugar responses, and another conducted while participants follow a provided diet at home over a longer period. Sometimes participants will eat almonds before meals, and sometimes they will not. The study hypothesis is that eating almonds before meals will lower blood sugar rises after eating, and that some people will benefit more than others in a consistent way that can be observed both in the clinic and during everyday living.
- Conditions
- Glucose Control, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Precision Medicine, Nutrition
- Being tested
- Premeal almond ingestion
- Keywords
- Nutrition, Precision Medicine, Precision Nutrition, Glucose Control, Impaired Glucose Tolerance, Insulin Resistance, Prediabetes
- Medical subject headings
- Prediabetic State, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premeal almond ingestionDietary supplement
Premeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal
| Study group | Role | What they receive |
|---|---|---|
| Randomization Sequence 1 | Experimental | One of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT+, MMTT- | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). Receives: Dietary Supplement: Premeal almond ingestion |
| Randomization Sequence 2 | Experimental | One of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT-, MMTT+ | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). Receives: Dietary Supplement: Premeal almond ingestion |
| Randomization Sequence 3 | Experimental | One of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT-, MMTT+ | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). Receives: Dietary Supplement: Premeal almond ingestion |
| Randomization Sequence 4 | Experimental | One of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT+, MMTT- | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). Receives: Dietary Supplement: Premeal almond ingestion |
| Randomization Sequence 5 | Experimental | One of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT+, MMTT- | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). Receives: Dietary Supplement: Premeal almond ingestion |
| Randomization Sequence 6 | Experimental | One of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT-, MMTT+ | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). Receives: Dietary Supplement: Premeal almond ingestion |
| Randomization Sequence 7 | Experimental | One of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT-, MMTT+ | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). Receives: Dietary Supplement: Premeal almond ingestion |
| Randomization Sequence 8 | Experimental | One of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT+, MMTT-, | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). Receives: Dietary Supplement: Premeal almond ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose assessed during acute meal test
The primary endpoint will be the difference in plasma glucose incremental area under the curve (iAUC) assessed via intravenous blood sampling over three hours following a standardized mixed meal tolerance test (MMTT) with premeal ingestion of 18 g of almonds 30 minutes prior (MMTT+) compared to without (MMTT-). This effect will be averaged across the replicated acute challenge visits in the repeated crossover design.
Measured: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
Secondary outcomes (2)
Interindividual variability in the postprandial glucose assessed during acute meal test
Variability in response to the single-dose, acute premeal almond supplementation prior to the MMTT will be characterized according to previously established procedures using Pearson's correlation between the first and second replicate of the control-adjusted treatment effect (i.e., MMTT+ vs MMTT-). That is, the correlation between the difference in iAUC during the first crossover trial (i.e., iAUC during MMTT+ minus iAUC during MMTT-) and the difference in iAUC during the second crossover trial (i.e., iAUC during MMTT+ minus iAUC during MMTT-).
Measured: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
Consistency between acute glycemic response and longer-term glycemic control
Whether the individual glucose-lowering effect of the almond preload observed during the acute, repeated crossover, controlled in-laboratory MMTT predicts an individual's glycemic control during the 10-day, free-living, controlled-feeding phase in which almonds will be consumed thrice daily prior to each main meal on the background of a Standard American diet. We will evaluate this via the regression coefficient derived from a linear regression with the magnitude of the acute treatment effect in Days 1-4 (i.e., the difference in iAUC between MMTT+ and MMTT- averaged between both crossover trials) as the predictor and the magnitude of the treatment effect in Days 5-25 (i.e., the difference in average iAUC across the 10-day controlled feeding diet periods between MMTT+ and MMTT-) as the outcome.
Measured: Days 1-4: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes. Days 5-25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start23 Jun 2026
- Primary completionMar 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose ControlStudies 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
- Crossover
- Model description
- The study consists of two phases using a crossover interventional design. In Phase 1, participants complete two cross-over trials (i.e., a total of four acute visits), including twice with an almond preload (active condition) and twice without (control condition). In Phase 2, participants complete one cross-over trial (i.e., a total of two 10-day study periods), including one with an almond preload prior to each meal (active condition) and one without (control condition). Given the repeated crossover nature of Phase 1 and the single crossover nature of Phase 2 of the study, there are a total of 8 possible visit sequences (i.e., "arms").
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaja Falkenhain, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603739
- Sponsor's protocol ID
- PBRC 2026-009
- Acronym
- NUTS
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared upon reasonable request to the study investigator and upon successful execution of a data transfer/sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interindividual Variability in the Effect of Premeal Almond Supplementation on Glycemic Control - a Double Crossover Study
- ClinicalTrials.gov ID
- NCT07603739
- Acronym / sponsor ID
- NUTS / PBRC 2026-009
- Conditions
- Glucose Control, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Precision Medicine, Nutrition
- Keywords
- Nutrition, Precision Medicine, Precision Nutrition, Glucose Control, Impaired Glucose Tolerance, Insulin Resistance, Prediabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 May 2026 (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.
The goal of this study is to learn whether eating a small serving of almonds before meals can improve blood sugar control in adults who have early signs of problems with blood sugar regulation. The main questions it aims to answer are:
- Does eating almonds before a meal reduce the rise in blood sugar after eating?
- Do some people consistently benefit more than others from eating almonds before meals?
Detailed description
Large rises in blood sugar after eating are an early warning sign of type 2 diabetes, and simple dietary strategies may help lower this risk. This study aims to understand whether eating a small serving of almonds before meals can help reduce postprandial blood sugar levels in adults who are at increased risk for developing type 2 diabetes. Participants will take part in two phases of the study: one conducted in a research clinic to carefully measure short-term blood sugar responses, and another conducted while participants follow a provided diet at home over a longer period. Sometimes participants will eat almonds before meals, and sometimes they will not. The study hypothesis is that eating almonds before meals will lower blood sugar rises after eating, and that some people will benefit more than others in a consistent way that can be observed both in the clinic and during everyday living.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- The study consists of two phases using a crossover interventional design. In Phase 1, participants complete two cross-over trials (i.e., a total of four acute visits), including twice with an almond preload (active condition) and twice without (control condition). In Phase 2, participants complete one cross-over trial (i.e., a total of two 10-day study periods), including one with an almond preload prior to each meal (active condition) and one without (control condition). Given the repeated crossover nature of Phase 1 and the single crossover nature of Phase 2 of the study, there are a total of 8 possible visit sequences (i.e., "arms").
| Arm | Type | Receives |
|---|---|---|
| Randomization Sequence 1 | Experimental | Dietary Supplement: Premeal almond ingestionOne of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT+, MMTT- | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). |
| Randomization Sequence 2 | Experimental | Dietary Supplement: Premeal almond ingestionOne of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT-, MMTT+ | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). |
| Randomization Sequence 3 | Experimental | Dietary Supplement: Premeal almond ingestionOne of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT-, MMTT+ | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). |
| Randomization Sequence 4 | Experimental | Dietary Supplement: Premeal almond ingestionOne of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT+, MMTT- | Phase 2: SAD+, SAD-. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). |
| Randomization Sequence 5 | Experimental | Dietary Supplement: Premeal almond ingestionOne of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT+, MMTT- | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). |
| Randomization Sequence 6 | Experimental | Dietary Supplement: Premeal almond ingestionOne of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT-, MMTT+ | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). |
| Randomization Sequence 7 | Experimental | Dietary Supplement: Premeal almond ingestionOne of the randomization sequences. Phase 1: MMTT+, MMTT-, MMTT-, MMTT+ | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). |
| Randomization Sequence 8 | Experimental | Dietary Supplement: Premeal almond ingestionOne of the randomization sequences. Phase 1: MMTT-, MMTT+, MMTT+, MMTT-, | Phase 2: SAD-, SAD+. In Phase 1, MMTT+ refers to a mixed meal tolerance test with premeal almond ingestion (active condition). MMTT- refers to a mixed meal tolerance test without premeal almond ingestion (control condition). In Phase 2, SAD+ refers to the 10-day controlled feeding diet period using a Standard American Diet with thrice daily premeal almond ingestion (active condition). SAD- refers to the 10-day controlled feeding diet period using a Standard American Diet without premeal almond ingestion (control condition). |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adults aged 25-50 years
- Females over 40 years must have had a cycle in the last 6 months
- Body mass index (BMI) at least 18.5 and at most 55.0 kg/m2
- Impaired blood glucose by at least one of the following criteria:
- Fasting blood glucose at least 100 mg/dL (5.6 mmol/L) and less than 125 mg/dL (6.9 mmol/L)
Key exclusion criteria (11 listed)
- Weight change ≥5% in past 6 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study based on self-report
- Recent history within past 12 months of medical provider-diagnosed cardiovascular, renal, or liver disease that required treatment
- Current or past diagnosis of cancer (except skin cancer) in the last 5 years
- Current or past diagnosis of type 1 or type 2 diabetes
- Recent history within past 12 months of medical provider-diagnosed gastrointestinal or neurological disorders if not managed/stable for at least 3 months (with or without treatment)
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 |
|---|---|---|
| Premeal almond ingestionPremeal almond ingestion (18 g; ~100 kcal) 30 minutes prior to meal | Dietary supplement | Randomization Sequence 1, Randomization Sequence 2, Randomization Sequence 3, Randomization Sequence 4, Randomization Sequence 5, Randomization Sequence 6, Randomization Sequence 7, Randomization Sequence 8 |
Primary outcome
Postprandial glucose assessed during acute meal test
Time frame: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
The primary endpoint will be the difference in plasma glucose incremental area under the curve (iAUC) assessed via intravenous blood sampling over three hours following a standardized mixed meal tolerance test (MMTT) with premeal ingestion of 18 g of almonds 30 minutes prior (MMTT+) compared to without (MMTT-). This effect will be averaged across the replicated acute challenge visits in the repeated crossover design.
2 secondary outcomes
Interindividual variability in the postprandial glucose assessed during acute meal test
Time frame: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.
Consistency between acute glycemic response and longer-term glycemic control
Time frame: Days 1-4: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes. Days 5-25
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No. Data will be shared upon reasonable request to the study investigator and upon successful execution of a data transfer/sharing agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Premeal almond ingestion in people with Glucose Control and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Pennington Biomedical Research Center 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaja Falkenhain, PhD (225-763-2558, kaja.falkenhain@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose assessed during acute meal test (time frame: Days 1-4: -35 minutes, -5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes relative to ingestion of premeal almonds at -30 minutes (if applicable) and the mixed meal tolerance test at 0 minutes.). 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 17 Jul 2026.