Almonds for Metabolic Syndrome

Overseen By Sandra Uesugi, RN, BSN, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Oregon State University

Must not be taking: Anti-inflammatories, Ezetimibe, Orlistat, Antibiotics

Disqualifiers: Nut allergy, Tobacco use, Cardiovascular disease, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Almonds are a good source of beneficial compounds. This study will investigate if eating almonds everyday for 12 weeks can affect gut health and inflammation in persons with metabolic syndrome. Investigators will measure changes in metabolism, heart health, and the levels of vitamins and other compounds from almonds.

Will I have to stop taking my current medications?

The trial requires you to stop taking probiotic supplements, multivitamins, and supplements containing vitamin E, magnesium, calcium, iron, zinc, and copper one week before and during the study. It does not specify stopping other medications, but you should check with the trial coordinators for more details.

What data supports the effectiveness of the treatment Almond, Prunus dulcis, Prunus amygdalus, Amygdalus communis, Crackers for metabolic syndrome?

Research shows that almonds can improve blood sugar control and cholesterol levels, which are important for managing metabolic syndrome. Studies have found that eating almonds can help reduce body fat, lower cholesterol, and improve blood sugar levels in people with type 2 diabetes, which is related to metabolic syndrome. ^{1 2 3 4 5}

Is almond consumption safe for humans?

Research shows that almonds are generally safe for humans. They are used in cosmetics and have been studied in clinical trials for their health benefits, including lowering cholesterol and supporting heart health. No significant safety concerns have been reported in these studies. ^{2 3 6 7 8}

How does the almond treatment differ from other treatments for metabolic syndrome?

Almonds are unique because they are a natural food that can improve metabolic health by lowering cholesterol, reducing body fat, and enhancing blood sugar control, unlike many standard treatments that may rely on medications. They are rich in healthy fats, fiber, and nutrients like vitamin E, which contribute to their beneficial effects on heart health and diabetes risk factors. ^{2 4 5 8 9}

Research Team

Laura Beaver, PhD

Principal Investigator

Oregon State University

Eligibility Criteria

Adults aged 35-60 with metabolic syndrome, willing to eat almonds daily and avoid other nuts, probiotics, multivitamins, and certain supplements for 13 weeks. Participants should have hypertension, high blood sugar, central obesity or abnormal cholesterol levels but no allergies to nuts/wheat/gluten, heavy alcohol use, recent tobacco use or antibiotic intake.

Inclusion Criteria

Willing to maintain current eating patterns (no significant diet change during study)

I am willing to stop taking probiotic supplements for the study duration.

I am willing to stop taking certain vitamins and supplements for 13 weeks.

Exclusion Criteria

I have not used tobacco or smoked any substance in the last 3 months.

I have had weight loss surgery or have a chronic digestive condition.

I have been diagnosed with hemochromatosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume 2 ounces of almonds or caloric equivalent crackers daily to assess impact on gut health and inflammation

12 weeks

3 visits (in-person) at baseline, week 4, and week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Almond
• Crackers

Trial Overview The trial is testing if consuming almonds every day for 12 weeks can improve gut health and reduce inflammation in people with metabolic syndrome. The effects on metabolism and heart health will be monitored along with the impact of almond-derived nutrients.

Participant Groups

Group I: Almonds Active Control 1 Intervention

Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks

Group II: Crackers Placebo Group 1 Intervention

Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds)

Who Is Running the Clinical Trial?

Oregon State University

Lead Sponsor

Trials

51

Recruited

8,300+

Findings from Research

Oral administration of sweet almond suspension (SAS) at a dose of 1428 mg/kg significantly improved blood biochemical parameters in hyperlipidemic male albino mice, reducing harmful lipid levels (total cholesterol, triacylglycerol, LDL-C, and VLDL-C) and increasing beneficial HDL-C levels.

SAS treatment also affected blood clotting parameters, increasing prothrombin time and clotting time, while decreasing platelet count, indicating potential effects on blood coagulation in addition to lipid profile improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sweet almond (Prunus amygdalus) suspension on blood biochemical parameters in experimentally induced hyperlipidemic mice. Tarmoos, AA., Kafi, LA.[2022]

In a 12-week study involving 20 patients with type 2 diabetes, adding approximately 60 grams of almonds daily improved glycemic control and reduced body fat compared to a control diet.

The almond diet significantly lowered total cholesterol and LDL cholesterol levels, indicating potential cardiovascular benefits for patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Almond consumption improved glycemic control and lipid profiles in patients with type 2 diabetes mellitus. Li, SC., Liu, YH., Liu, JF., et al.[2022]

Prunus amygdalus (PA) nuts significantly improved cognitive functions in rats with scopolamine-induced amnesia, showing promise as a memory-restorative agent after 7 and 14 days of treatment at various doses.

PA nuts also reduced brain cholinesterase activity and lowered cholesterol and triglyceride levels, suggesting they may help counteract factors associated with Alzheimer's disease and cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy study of Prunus amygdalus (almond) nuts in scopolamine-induced amnesia in rats. Kulkarni, KS., Kasture, SB., Mengi, SA.[2021]

The Expert Panel for Cosmetic Ingredient Safety reviewed new data since their 1983 assessment and confirmed that Sweet Almond Seed Meal is safe for topical use.

The safety conclusion is based on updated information regarding product types, usage frequency, and concentrations, ensuring it remains appropriate for human application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prunus Amygdalus Dulcis (Sweet Almond) Seed Meal. Burnett, CL., Bergfeld, WF., Belsito, DV., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Consuming Almonds on Insulin Sensitivity and Other Cardiometabolic Health Markers in Adults With Prediabetes. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Health benefits of almonds beyond cholesterol reduction. [2015]

3. India pubmed.ncbi.nlm.nih.gov

Effects of sweet almond (Prunus amygdalus) suspension on blood biochemical parameters in experimentally induced hyperlipidemic mice. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

The effect of almonds on inflammation and oxidative stress in Chinese patients with type 2 diabetes mellitus: a randomized crossover controlled feeding trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Almond consumption improved glycemic control and lipid profiles in patients with type 2 diabetes mellitus. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Efficacy study of Prunus amygdalus (almond) nuts in scopolamine-induced amnesia in rats. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Prunus Amygdalus Dulcis (Sweet Almond) Seed Meal. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Comprehensive Review of Almond Clinical Trials on Weight Measures, Metabolic Health Biomarkers and Outcomes, and the Gut Microbiota. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Almond ingestion at mealtime reduces postprandial glycemia and chronic ingestion reduces hemoglobin A(1c) in individuals with well-controlled type 2 diabetes mellitus. [2022]