Almonds for Prediabetes

(NUTS Trial)

Overseen By Kaja Falkenhain, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Glucose-lowering except biguanides

Disqualifiers: Cardiovascular, Renal, Liver, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether eating a small serving of almonds before meals (premeal almond ingestion) can help control blood sugar in individuals with early signs of blood sugar issues, such as prediabetes. Researchers aim to determine if almonds can prevent significant blood sugar spikes after eating and if certain individuals benefit more than others. The study includes different phases where participants will either consume almonds before meals or not, to observe the effects. It suits adults who have noticed blood sugar control issues, like fasting blood sugar above 100 mg/dL, and who are willing to eat almonds regularly. As an unphased trial, this study provides a unique opportunity to explore natural dietary interventions for improved blood sugar management.

Is there any evidence suggesting that premeal almond ingestion is safe?

Research has shown that eating almonds before meals is generally safe. Studies have found that consuming about 20 grams of almonds before eating can lower blood sugar levels without causing serious side effects. In one study, most participants who ate almonds before meals reported no major problems and experienced better blood sugar control.

The studies focused on individuals with prediabetes and found that almonds were easy to tolerate. Participants did not report significant harmful effects from regularly eating almonds. This suggests that adding almonds to the diet before meals is a safe way to potentially help manage blood sugar levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for prediabetes focus on medications like metformin or lifestyle changes such as diet and exercise. However, this trial explores a unique approach by using premeal almond ingestion. Almonds are packed with healthy fats, fiber, and antioxidants, which may help regulate blood sugar levels naturally. Researchers are excited about this because it offers a simple, dietary-based intervention that could potentially improve glucose tolerance and delay or prevent the onset of type 2 diabetes without the need for medication.

What evidence suggests that premeal almond ingestion could be effective for improving blood sugar control in prediabetes?

This trial will evaluate the effects of premeal almond ingestion on blood sugar control in individuals with prediabetes. Studies have shown that eating almonds before meals can help manage blood sugar levels. In one study, a small serving of almonds before a meal reduced blood sugar spikes by 14.1% after two hours. Another study found that 76.7% of people who ate almonds before meals reached normal blood sugar levels. Additionally, research indicated that eating almonds before meals lowered blood sugar levels by 10.07% compared to those who didn't eat almonds. These findings suggest that almonds might help improve blood sugar control in people with early signs of blood sugar issues. Participants in this trial will be randomized into different sequences to assess the impact of premeal almond ingestion compared to no almond ingestion. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who have early signs of blood sugar problems, such as prediabetes or insulin resistance. People with more serious health issues or other conditions may not be able to join.

Inclusion Criteria

Impaired blood glucose defined by fasting blood glucose at least 100 mg/dL (5.6 mmol/L) and less than 125 mg/dL (6.9 mmol/L)

Willing and able to ingest acetaminophen as part of study procedures

Able to read, speak, and understand English

Exclusion Criteria

Binge and/or heavy drinking defined as >3 drinks on any given occasion and/or >7 drinks/week

I have had cancer (not skin cancer) within the past 5 years.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Mixed Meal Tolerance Test (MMTT)

Participants undergo a mixed meal tolerance test with and without premeal almond ingestion to assess acute postprandial glucose response.

4 days

Multiple visits for blood sampling

Phase 2: Controlled Feeding Diet

Participants follow a 10-day controlled feeding diet with and without premeal almond ingestion to assess longer-term glycemic control.

10 days

Home-based with potential clinic visits

Follow-up

Participants are monitored for safety and effectiveness after the controlled feeding diet phase.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Premeal almond ingestion

Trial Overview

The study tests if eating a small serving of almonds before meals helps control blood sugar levels after eating. Researchers also want to see if some people benefit more than others from this approach.

How Is the Trial Designed?

Group I: Randomization Sequence 8 Experimental Treatment 1 Intervention

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).

Group II: Randomization Sequence 7 Experimental Treatment 1 Intervention

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).

Group III: Randomization Sequence 6 Experimental Treatment 1 Intervention

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).

Group IV: Randomization Sequence 5 Experimental Treatment 1 Intervention

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).

Group V: Randomization Sequence 4 Experimental Treatment 1 Intervention

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).

Group VI: Randomization Sequence 3 Experimental Treatment 1 Intervention

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).

Group VII: Randomization Sequence 2 Experimental Treatment 1 Intervention

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).

Group VIII: Randomization Sequence 1 Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10169634/

Beneficial effects of premeal almond load on glucose profile ...

In our study, ingestion of 20 g of almonds 30 min before an oral glucose load showed a significant decrease in blood glucose, serum insulin, ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07603739

Eating Almonds Before a Meal to Control Blood Sugar

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 ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405457722014383

Premeal almond load decreases postprandial glycaemia ...

[23] showed that a premeal load of 15 g of almonds decreased 2 h blood glucose value by 14.1% and isolated 1 h postprandial hyperglycemia by 19.4% in ...

4.

examine.com

examine.com/research-feed/study/9LELpd/?srsltid=AfmBOooAB0s1m61a9Z_40PMtjQ-Y0ENq_2XDQnSKc9I3he7HahK6meqN

Eating almonds before every meal may result in ...

Especially noteworthy was the finding that 76.7% of participants eating almonds before each meal achieved normal glucose tolerance at the end of ...

5.

jzar.org

jzar.org/plugins/generic/pdfJsViewer/pdf.js/web/viewer.html?file=%2Findex.php%2Findex%2Flogin%2FsignOut%3Fsource%3D%2Esolalal.com%2Fsugar2%2F&id=2PbLaf5qM93

Almonds Effectiveness Lowering Blood Sugar Study

Do almonds really lower blood sugar according to studies? Some trials, especially pre-meal loading in prediabetes groups, show reductions in postprandial ...

6.

examine.com

examine.com/research-feed/study/9LELpd/?srsltid=AfmBOoq50nKHVmF9iSxXCiGejopl5KM51RIPvmaSMrjr6d-cffP0Iv4F

Eating almonds before every meal may result in ...

Especially noteworthy was the finding that 76.7% of participants eating almonds before each meal achieved normal glucose tolerance at the end of ...

7.

almonds.org

almonds.org/about-us/press-room/eating-almonds-improved-blood-sugar-levels-prediabetes

Eating Almonds Before Meals Improved Blood Sugar ...

Premeal almond load decreases postprandial glycaemia, adiposity and reversed prediabetes to normoglycemia: a randomized controlled trial.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36963852/

Premeal almond load decreases postprandial glycaemia, ...

Conclusion: Incorporation of 20 g of almonds, 30 min before each major meal leads to significant improvement in body weight, WC, glycemia (particularly PPHG), ...