NCT04958018

Brief Summary

The PURPOSE of this study is to see if eating almonds for four weeks will reduce muscle damage, soreness, and inflammation during several days of recovery from eccentric exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 17, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

June 17, 2021

Last Update Submit

December 15, 2021

Conditions

Muscular Injury

Keywords

almondsexerciseinflammationoxylipinscytokines

Outcome Measures

Primary Outcomes (1)

  • Serum concentration of creatine kinase

    Muscle damage biomarker

    Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

Secondary Outcomes (9)

  • Plasma concentrations of pro-inflammatory oxylipins: 19-hydroxy-eicosatetraenoic acid (HETE), 20-HETE, 20-cooh-AA, 8,9-dihydroxy-eicosatrienoic (all ng/ml) acid; (diHETrE), 14,15-diHETrE

    Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

  • Plasma concentration of IL-6

    Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

  • Urine almond metabolites: epicatechin, catechin, epiafzelechin, gallic acid, ellagic acid (all uM)

    Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

  • 30-second Wingate cycle test watts

    Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

  • Leg-back strength kilograms

    Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

  • +4 more secondary outcomes

Study Arms (2)

Almond

EXPERIMENTAL

57 g almonds each day in split doses (half in the morning, half in the afternoon)

Dietary Supplement: Almonds

Snack Bar

ACTIVE COMPARATOR

snack bar group will ingest a matched calorie, common snack bar in split doses (324 calories/day, Nutri-Grain cereal bars, 120 kcal each)

Dietary Supplement: Snack bars

Interventions

AlmondsDIETARY_SUPPLEMENT

almond (Prunus dulcis) consumption

Almond
Snack barsDIETARY_SUPPLEMENT

324 calories/day, Nutri-Grain cereal bars, 120 kcal each

Snack Bar

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, ages 30-65 years.
  • Non-smoker.
  • Body mass index of 23 to 30 kg/m2.
  • Not engaged in regular weight lifting (less than 3 sessions per week).
  • Agree to train normally, maintain weight, and avoid the regular use of protein supplements, large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation (especially Advil, Motrin, aspirin, and similar drugs) during the study.
  • Categorized as "low risk" using a screening questionnaire.
  • Generally healthy and without disease including heart disease, stroke, cancer, diabetes, arthritis.
  • Willing to collect two 24-hour urine samples.

You may not qualify if:

  • Inability to comply with study requirements.
  • Engaged in regular weight training (3 or more times a week).
  • Pregnant or breastfeeding.
  • Any other condition that would interfere with successful completion of the study.
  • Current diagnosis of heart disease, diabetes, or cancer (except for skin cancer).
  • History of allergic reactions to almonds or cereal bars.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Motor ActivityInflammation

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David C Nieman

    Appalachian State Univ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

July 12, 2021

Study Start

June 16, 2021

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

December 16, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Will provide data upon request.

Locations

US(1)