Almonds for Overweight Active Older Adults

Overseen By Saiful Singar, M.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: Antihypertensives

Disqualifiers: Cardiovascular diseases, Type 2 diabetes, others

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether eating almonds twice a day for 12 weeks can improve energy levels, physical performance, and overall health in active, overweight older adults. Participants will snack on either almonds or a calorie-matched granola bar to determine which provides more benefits. The trial seeks postmenopausal women and active men aged 50-59 who do not have chronic illnesses like cancer and exercise for over 30 minutes, three days a week. This study offers a chance to explore whether almonds can enhance health. As an unphased study, it provides a unique opportunity to contribute to research on dietary impacts on health without the constraints of traditional clinical trial phases.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking more than one blood pressure medication or have been on them for less than 3 months, you may not be eligible to participate.

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

Research shows that eating almonds is generally safe. Studies have found that almonds can improve physical performance and lower inflammation markers like CRP and IL-6, which relate to heart health. Importantly, no major side effects have been reported from consuming almonds, even in larger amounts than those used in the study. This suggests that most people can eat almonds without issues. Overall, evidence supports that almonds are safe to eat and may offer health benefits for those who include them in their diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for managing weight in older adults focus on calorie restriction or increased physical activity. However, this new approach is unique because it involves consuming almonds, which are packed with healthy fats, fiber, and protein. Researchers are excited about this treatment because almonds may help regulate appetite and improve metabolic health, potentially offering a more natural and sustainable way to support weight management. Unlike other interventions that might require strict diets or medications, this almond-based approach leverages a simple dietary addition with the promise of enhancing overall well-being in active older adults.

What evidence suggests that almond consumption might be an effective treatment for overweight active older adults?

Research has shown that eating almonds can improve physical performance and body shape. Ingredients such as L-arginine and magnesium in almonds boost physical abilities in active older adults. Studies also indicate that almonds help maintain muscle strength and may reduce pain. Additionally, almond consumption is associated with better overall diet quality and a smaller waist size. This trial will compare the effects of almond consumption with a placebo-matched supplement. Overall, these findings suggest that almonds positively affect energy, body shape, and physical abilities. ^{1 6 7 8 9}

Who Is on the Research Team?

Robert Hickner, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for active, overweight adults aged 50-59 with a BMI of 25.0 to 29.9 kg/m2 who are free from chronic diseases like cancer and cardiovascular conditions. Participants should not be on certain medications, have musculoskeletal issues that limit activity, or be involved in other studies.

Inclusion Criteria

No restrictions based on race, ethnicity, or socioeconomic status

BMI of 25.0 kg/m2 to 29.9 kg/m2 will be included

I am between 50 and 59 years old.

Exclusion Criteria

Participants participating in a weight loss program or having lost or gain ≥10% bodyweight within the last 6 months

Currently using tobacco

Frequent tree nut consumers (>2 servings/week)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants complete baseline assessments including RMR, body composition, vascular assessments, and physical performance tests

1 week

2 visits (in-person)

Treatment

Participants consume either almonds or a calorie-matched granola bar twice daily for 12 weeks

12 weeks

3 visits (in-person)

Washout

Participants undergo a 4-week washout period before crossing over to the alternate treatment

4 weeks

Crossover Treatment

Participants switch to the alternate snack regimen for another 12 weeks

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Almond Consumption
• Placebo Consumption

Trial Overview The study tests if eating almonds twice daily for 12 weeks can improve energy use, physical performance, vascular function, inflammation levels, sleep quality, mood status and body composition in active older adults compared to a similar calorie control snack.

How Is the Trial Designed?

Group I: Almond supplement Experimental Treatment 1 Intervention

Participants will consume 32 g dry roasted, unsalted almonds twice a day for 12 weeks

Group II: Placebo matched supplement Placebo Group 1 Intervention

Participants will consume 100 g granola bar, calorie matched to Almond, twice a day for 12 weeks

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Almond Board of California

Collaborator

Trials

35

Recruited

2,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04778371

The Effects of Almond Consumption on Functional ... Constituents of almonds including L-arginine and magnesium have been shown to increase anaerobic threshold and physical performance in healthy active older ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11381864/

Almond Consumption Modestly Improves Pain Ratings ... This study demonstrates that 2.0 oz/d of almonds modestly reduces pain, better maintains muscle strength, and reduces the CK response to eccentric-based ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666149724000537

Almond snacking modestly improves diet quality and waist ... This study demonstrates that a 57 g/d serving of almonds modestly improves diet quality and waist circumference.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8229803/

A Comprehensive Review of Almond Clinical Trials on Weight ... Subgroup analyses showed that the level of almond weight loss was significantly better after durations of ≥6 weeks and doses of ≥45 g/day. The ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02347007

Impact of Almond Supplementation on Body Composition ... The purpose of this study is to determine whether introducing almonds into the diet of overweight and obese Blacks and Hispanics improves body composition, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9526836/

The Effects of Almond Consumption on Inflammatory ... Almond consumption beneficially affects CRP and IL-6 concentrations in adults. However, it has no beneficial effect on TNF-α, ICAM-1, or VCAM-1.

7. withpower.com withpower.com/trial/phase-overweight-2-2021-9ab5d

Almonds for Overweight Active Older Adults ... Almond Consumption will have tolerable side effects & efficacy for patients with Motor Skills, Childhood Obesity and Obesity. Learn more about the study.

8. nature.com nature.com/articles/s41598-025-14701-w

The impact of almond supplementation on oxidative stress ... This meta-analysis shows that almond supplementation, particularly at doses > 60 g/day, reduces oxidative DNA damage (e.g., 8-OHdG), lipid ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0965229922001145

A systematic review and meta-analysis of almond effect on ... Subgroup analysis revealed that almond consumption significantly decreased the serum C-reactive protein level in studies with duration < 84 day, at-risk ...