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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy male and female subjects aged 40-65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if eating almonds regularly can improve the immune system. The study involves overweight/non-obese adults aged 40-65. Almonds are rich in nutrients that might help the body fight infections better. Almonds have been studied for their potential health benefits, including their role in improving cardiovascular health, body weight management, and skin health.
Who is the study for?
This trial is for healthy men and women aged 40-65 with a BMI of 24-30. Participants should not have almond allergies, smoke, or consume more than two alcoholic drinks per day. They must also agree to stop taking multivitamins and supplements (except vitamin D and calcium) for 30 days before and during the study.
What is being tested?
The study aims to determine if eating almonds can boost immune function compared to a control group consuming pretzels. It's prompted by the need for better nutrition in light of COVID-19, suggesting diet might help strengthen immunity against infections.
What are the potential side effects?
Since almonds are generally safe, side effects may be rare but could include digestive discomfort or allergic reactions in sensitive individuals. The control food, pretzels, may cause similar minor digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowSelect...
I am between 40 and 65 years old and in good health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, after 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
change in Natural Killer Function
Secondary study objectives
change in Cytokines
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Almond (2 ounces)Experimental Treatment1 Intervention
Consume 2 ounces almond daily for 8 weeks
Group II: PretzelActive Control1 Intervention
Consume comparative amount of pretzel for 8 weeks
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for improving immune health often focus on nutritional components like vitamins (e.g., Vitamin C and D), minerals (e.g., zinc), and antioxidants (e.g., those found in almonds). Vitamin C enhances the production and function of white blood cells, which are crucial for fighting infections.
Vitamin D modulates the immune response and reduces inflammation. Zinc is essential for the normal development and function of immune cells.
Antioxidants help to neutralize free radicals, reducing oxidative stress and supporting overall immune function. These mechanisms are vital for immune health patients as they help to strengthen the body's defense system, reduce the risk of infections, and improve overall health outcomes.
Proposed Anti-Inflammatory Diet Reduces Inflammation in Compliant, Weight-Stable Patients with Rheumatoid Arthritis in a Randomized Controlled Crossover Trial.Dietary Interventions with or without Omega-3 Supplementation for the Management of Rheumatoid Arthritis: A Systematic Review.Minimal changes in telomere length after a 12-week dietary intervention with almonds in mid-age to older, overweight and obese Australians: results of a randomised clinical trial.
Proposed Anti-Inflammatory Diet Reduces Inflammation in Compliant, Weight-Stable Patients with Rheumatoid Arthritis in a Randomized Controlled Crossover Trial.Dietary Interventions with or without Omega-3 Supplementation for the Management of Rheumatoid Arthritis: A Systematic Review.Minimal changes in telomere length after a 12-week dietary intervention with almonds in mid-age to older, overweight and obese Australians: results of a randomised clinical trial.
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Who is running the clinical trial?
San Diego State UniversityLead Sponsor
169 Previous Clinical Trials
114,786 Total Patients Enrolled
Shirin Hooshmand, PhD, RDStudy DirectorSan Diego State University
3 Previous Clinical Trials
196 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 40 and 65 years old and in good health.I am not willing to stop taking my multivitamins and supplements, except for vitamin D and calcium, for 30 days before or during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Almond (2 ounces)
- Group 2: Pretzel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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