Muscle SorenessNCT04787718
Almond for Physical Performance
A study testing Almond in people with Muscle Soreness and Energy, run by San Diego State University at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness, Energy
- What is being tested?
- Almond
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 3 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 30-50 years old
- BMI of 23-30
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92182-7251
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Soreness, Energy
- Being tested
- Almond, Control group
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondOther
2.0 oz of raw, shelled, unsalted almonds
Control groupOther
an isocaloric amount of unsalted pretzels
| Study group | Role | What they receive |
|---|---|---|
| Almond | Experimental | Participants will consume 2.0 oz of raw, shelled, unsalted almonds. Receives: Other: Almond |
| Control group | Active comparator | an isocaloric (2.0 oz raw almonds) amount of unsalted pretzels daily. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in energy (vigor) perception
Energy (vigor) perception will be assessed using POMS questionnaire
Measured: At baseline , at 8 weeks
Changes from baseline in exercise performance
VO2max will be assessed for measuring exercise performance
Measured: At baseline , at 8 weeks
Secondary outcomes (2)
Changes from baseline in strength and power performance
strength and power performance by be measure by biodex
Measured: At baseline, at 8 weeks
Changes from baseline in muscle soreness
muscle soreness will be measured by DOMES questionnaire
Measured: At baseline, at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start15 Jul 2020
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Kern, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787718
- Sponsor's protocol ID
- 59997A
- Status last verified
- May 2022
- First submitted
- 3 Mar 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rayo VU, Cervantes M, Hong MY, Hooshmand S, Jason N, Liu C, North E, Okamoto L, Storm S, Witard OC, Kern M. Almond Consumption Modestly Improves Pain Ratings, Muscle Force Production, and Biochemical Markers of Muscle Damage Following Downhill Running in Mildly Overweight, Middle-Aged Adults: A Randomized, Crossover Trial. Curr Dev Nutr. 2024 Aug 7;8(9):104432. doi: 10.1016/j.cdnut.2024.104432. eCollection 2024 Sep.
PubMed 39257478
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roles of Almonds in Physical Performance
- ClinicalTrials.gov ID
- NCT04787718
- Acronym / sponsor ID
- 59997A
- Conditions
- Muscle Soreness, Energy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond | Experimental | Other: AlmondParticipants will consume 2.0 oz of raw, shelled, unsalted almonds. |
| Control group | Active comparator | Other: Control groupan isocaloric (2.0 oz raw almonds) amount of unsalted pretzels daily. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 30-50 years old
- BMI of 23-30
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almond2.0 oz of raw, shelled, unsalted almonds | Other | Almond |
| Control groupan isocaloric amount of unsalted pretzels | Other | Control group |
Primary outcome
Changes from baseline in energy (vigor) perception
Time frame: At baseline , at 8 weeks
Energy (vigor) perception will be assessed using POMS questionnaire
Changes from baseline in exercise performance
Time frame: At baseline , at 8 weeks
VO2max will be assessed for measuring exercise performance
2 secondary outcomes
Changes from baseline in strength and power performance
Time frame: At baseline, at 8 weeks
Changes from baseline in muscle soreness
Time frame: At baseline, at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 39257478Rayo VU, Cervantes M, Hong MY, Hooshmand S, Jason N, Liu C, North E, Okamoto L, Storm S, Witard OC, Kern M. Almond Consumption Modestly Improves Pain Ratings, Muscle Force Production, and Biochemical Markers of Muscle Damage Following Downhill Running in Mildly Overweight, Middle-Aged Adults: A Randomized, Crossover Trial. Curr Dev Nutr. 2024 Aug 7;8(9):104432. doi: 10.1016/j.cdnut.2024.104432. eCollection 2024 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond in people with Muscle Soreness and Energy, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in energy (vigor) perception (time frame: At baseline , at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04787718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.