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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The overall objective of this proposed randomized, crossover study is to determine the effect of 12 weeks of almond consumption, ingested as a snack twice daily, on energy expenditure, performance and functional related outcomes, in active, overweight, older adults, in comparison to 12 weeks of an isocaloric matched control snack. The central hypothesis of this study is, due to the nutritionally beneficial composition of almonds, that daily consumption of an almond snack for 12 weeks will contribute to improvements in energy expenditure, physical and functional performance, vascular function, inflammation/oxidative stress, sleep quality, mood status, and body composition in active, overweight and obese older adults compared to an isocaloric commercially available snack.

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

Active lifestyle (>30 minutes, 3 days/week)

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+