NCT04787718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

March 3, 2021

Last Update Submit

May 3, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes from baseline in energy (vigor) perception

    Energy (vigor) perception will be assessed using POMS questionnaire

    At baseline , at 8 weeks

  • Changes from baseline in exercise performance

    VO2max will be assessed for measuring exercise performance

    At baseline , at 8 weeks

Secondary Outcomes (2)

  • Changes from baseline in strength and power performance

    At baseline, at 8 weeks

  • Changes from baseline in muscle soreness

    At baseline, at 8 weeks

Study Arms (2)

Almond

EXPERIMENTAL

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

Other: Almond

Control group

ACTIVE COMPARATOR

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

Other: Control group

Interventions

AlmondOTHER

2.0 oz of raw, shelled, unsalted almonds

Almond

an isocaloric amount of unsalted pretzels

Control group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • BMI of 23-30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182-7251, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Myalgia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 9, 2021

Study Start

July 15, 2020

Primary Completion

May 3, 2022

Study Completion

May 3, 2022

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations