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Almond for Physical Performance

Primary Purpose

Muscle Soreness, Energy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Almond
Control group
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Muscle Soreness

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • San Diego State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Almond

Control group

Arm Description

Participants will consume 2.0 oz of raw, shelled, unsalted almonds.

an isocaloric (2.0 oz raw almonds) amount of unsalted pretzels daily.

Outcomes

Primary Outcome Measures

Changes from baseline in energy (vigor) perception
Energy (vigor) perception will be assessed using POMS questionnaire
Changes from baseline in exercise performance
VO2max will be assessed for measuring exercise performance

Secondary Outcome Measures

Changes from baseline in strength and power performance
strength and power performance by be measure by biodex
Changes from baseline in muscle soreness
muscle soreness will be measured by DOMES questionnaire

Full Information

First Posted
March 3, 2021
Last Updated
May 3, 2022
Sponsor
San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT04787718
Brief Title
Almond for Physical Performance
Official Title
Roles of Almonds in Physical Performance
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
May 3, 2022 (Actual)
Study Completion Date
May 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Soreness, Energy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Almond
Arm Type
Experimental
Arm Description
Participants will consume 2.0 oz of raw, shelled, unsalted almonds.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
an isocaloric (2.0 oz raw almonds) amount of unsalted pretzels daily.
Intervention Type
Other
Intervention Name(s)
Almond
Intervention Description
2.0 oz of raw, shelled, unsalted almonds
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
an isocaloric amount of unsalted pretzels
Primary Outcome Measure Information:
Title
Changes from baseline in energy (vigor) perception
Description
Energy (vigor) perception will be assessed using POMS questionnaire
Time Frame
At baseline , at 8 weeks
Title
Changes from baseline in exercise performance
Description
VO2max will be assessed for measuring exercise performance
Time Frame
At baseline , at 8 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline in strength and power performance
Description
strength and power performance by be measure by biodex
Time Frame
At baseline, at 8 weeks
Title
Changes from baseline in muscle soreness
Description
muscle soreness will be measured by DOMES questionnaire
Time Frame
At baseline, at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92182-7251
Country
United States

12. IPD Sharing Statement

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Almond for Physical Performance

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