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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating almonds daily for 12 weeks can improve gut health and reduce inflammation in people with metabolic syndrome. Researchers will assess changes in metabolism, heart health, and levels of vitamins and other almond compounds. Participants will consume either almonds (also known as Prunus dulcis, Prunus amygdalus, or Amygdalus communis) or crackers daily to determine which provides more benefits. Suitable candidates have metabolic syndrome—a combination of high blood pressure, high blood sugar, extra belly fat, and abnormal cholesterol levels—and do not regularly eat nuts or take certain supplements. As an unphased trial, this study offers a unique opportunity to contribute to understanding dietary impacts on metabolic health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that eating almonds is generally safe for most people. Studies have found that almonds can offer health benefits such as a smaller waist, lower cholesterol, and better blood sugar control. One study revealed that people with type 2 diabetes who consumed about 60 grams of almonds daily for 12 weeks improved their blood sugar levels and reduced body fat.

No specific evidence indicates serious safety issues with eating almonds, but allergies should be considered. Almonds are a common allergen, so anyone with a known nut allergy should avoid them. Overall, almonds are considered safe and well-tolerated for most people when included in a regular diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for metabolic syndrome involve medication or lifestyle changes like diet and exercise. However, almonds are unique because they offer a natural and simple dietary addition with potential health benefits. Researchers are excited about almonds because they contain healthy fats, fiber, and antioxidants, which might help improve cholesterol and blood sugar levels. Unlike medications, almonds have minimal side effects and can be easily incorporated into daily meals, making them an appealing option for managing metabolic syndrome.

What evidence suggests that eating almonds could be effective for metabolic syndrome?

Research has shown that eating almonds benefits people with metabolic syndrome. In this trial, participants in one arm will consume 2 ounces of unsalted, dry roasted almonds daily for 12 weeks. Studies have found that almonds can help reduce waist size and lower both total cholesterol and bad cholesterol (LDL-C) levels. One study found that people with type 2 diabetes who ate about 60 grams of almonds daily for 12 weeks improved their blood sugar control and reduced body fat. Almonds have also been shown to lower fasting blood sugar and a marker of long-term blood sugar levels called HbA1c. These findings suggest that almonds may help improve metabolism and heart health. ^{1 3 5 6 7}

Who Is on the Research Team?

Laura Beaver, PhD

Principal Investigator

Oregon State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7146189/

Almonds (Prunus Dulcis Mill. D. A. Webb) - PubMed Central Epidemiological studies and clinical trials have reported positive effects of nuts consumption against a significant number of pathologies such as obesity, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0271531725000636

Beneficial changes in total cholesterol, LDL-C, biomarkers ... Almond consumption decreased waist circumference, total cholesterol, and LDL-C concentrations in participants with metabolic syndrome. Data are change from ...

3. withpower.com withpower.com/trial/phase-syndrome-10-2022-0760f

Almonds for Metabolic Syndrome · Info for Participants 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 ...

4. mdpi.com mdpi.com/2072-6643/16/12/1964

The Effects of Almond Consumption on Cardiovascular ... Almond consumption has been shown to lower fasting blood glucose and glycated hemoglobin (HbA1c) levels. A systematic review and meta-analysis revealed that ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07085-7

The effect of bitter almond (Amygdalus communis L ... - Trials In this study, bitter almond gum-enriched juice consumption significantly reduced body weight, body mass index (BMI), serum triglyceride (TG), ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11207051/

The Effects of Almond Consumption on Cardiovascular Health ... A study demonstrated that the inclusion of almonds in the diet of patients with T2DM led to reductions in fasting glucose and insulin levels, as ...

7. cir-safety.org cir-safety.org/sites/default/files/RR_Sweet%20Almond.pdf

Safety Assessment of Prunus Amygdalus Dulcis (Sweet ... On the basis of the available data and clinical experience, it is concluded that Sweet Almond Oil and Almond Meal are safe for topical ...