- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04787718
Almond for Physical Performance
May 3, 2022 updated by: Mark Kern, San Diego State University
Roles of Almonds in Physical Performance
Investigators specific aims are to compare the effects of consuming daily snacks of raw, shelled, unsalted almonds (2.0 ounces) versus an isocaloric amount of another commonly consumed snack food (pretzels) on energy (vigor) perception and physical activity, exercise performance (VO2max and measures of strength), strength and power performance as well as muscle soreness recovery after strenuous eccentrically-biased exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To accomplish these aims, investigators will examine whether regular consumption of almonds versus a common snack food over a period of 8 weeks impacts longer term metabolic, physiological and behavioral responses related to energy sensations and exercise capacity/performance.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92182-7251
- San Diego State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 30-50 years old
- BMI of 23-30
Exclusion Criteria:
- smoking,
- medications known to impact inflammation,
- musculoskeletal limitations and
- use of supplements within 1 month of participation that are known to impact antioxidant
- use of supplements within 1 month of participation that are known to impact inflammatory status
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Almond
Participants will consume 2.0 oz of raw, shelled, unsalted almonds.
|
2.0 oz of raw, shelled, unsalted almonds
|
Active Comparator: Control group
an isocaloric (2.0 oz raw almonds) amount of unsalted pretzels daily.
|
an isocaloric amount of unsalted pretzels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in energy (vigor) perception
Time Frame: At baseline , at 8 weeks
|
Energy (vigor) perception will be assessed using POMS questionnaire
|
At baseline , at 8 weeks
|
Changes from baseline in exercise performance
Time Frame: At baseline , at 8 weeks
|
VO2max will be assessed for measuring exercise performance
|
At baseline , at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in strength and power performance
Time Frame: At baseline, at 8 weeks
|
strength and power performance by be measure by biodex
|
At baseline, at 8 weeks
|
Changes from baseline in muscle soreness
Time Frame: At baseline, at 8 weeks
|
muscle soreness will be measured by DOMES questionnaire
|
At baseline, at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2020
Primary Completion (Actual)
May 3, 2022
Study Completion (Actual)
May 3, 2022
Study Registration Dates
First Submitted
March 3, 2021
First Submitted That Met QC Criteria
March 5, 2021
First Posted (Actual)
March 9, 2021
Study Record Updates
Last Update Posted (Actual)
May 5, 2022
Last Update Submitted That Met QC Criteria
May 3, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 59997A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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