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Almonds for Overweight Active Older Adults
N/A
Recruiting
Led By Bahram Arjmandi, PhD
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the ages of 50-59 years
Free of any chronic diseases such as cancer
Must not have
Uncontrolled hypertension (≥160/100 mmHg)
Individuals diagnosed with cardiovascular diseases (CVD) Type 2-diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Summary
This trial will study the effects of almond consumption on energy expenditure, performance, and related outcomes in active, overweight older adults, compared to a control snack.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include digestive discomfort or allergic reactions due to almond consumption; however specific side effects related to the intervention are not detailed in the provided information.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 59 years old.
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I do not have any chronic diseases, including cancer.
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I am a physically active man or a postmenopausal woman.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood pressure is not higher than 160/100 mmHg.
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I have been diagnosed with Type 2 diabetes and cardiovascular disease.
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I have no other active chronic diseases like cancer, asthma, or liver disease.
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I am not post-menopausal nor on hormone replacement therapy.
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I do not have any bone or joint issues that would stop me from completing the study.
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I am on more than one blood pressure medication or started them recently.
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I am currently taking supplements like creatine or whey protein.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effect of almonds on functional performance
Effect of almonds on submaximal aerobic capacity (VO2)
Secondary study objectives
Effect of Almond on arterial health using flow mediated dilation
Effect of Almond on arterial health using pulse wave velocity
Effect of Almond on oxidative stress
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Almond supplementExperimental Treatment1 Intervention
Participants will consume 32 g dry roasted, unsalted almonds twice a day for 12 weeks
Group II: Placebo matched supplementPlacebo Group1 Intervention
Participants will consume 100 g granola bar, calorie matched to Almond, twice a day for 12 weeks
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Who is running the clinical trial?
Florida State UniversityLead Sponsor
220 Previous Clinical Trials
36,405 Total Patients Enrolled
19 Trials studying Obesity
1,810 Patients Enrolled for Obesity
Almond Board of CaliforniaOTHER
34 Previous Clinical Trials
2,171 Total Patients Enrolled
7 Trials studying Obesity
439 Patients Enrolled for Obesity
Bahram Arjmandi, PhDPrincipal Investigator - Florida State University
Florida State University
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