NCT05346211

Brief Summary

Recent evidence suggests that curcumin supplementation may reduce muscle inflammation, oxidative markers, and muscle damage. The most favourable dosage to elicit these ergogenic effects are yet to be established; both 750mg \& 1500mg has been shown to be effective. Curcumin supplementation has been ingested in numerous different ways however, no previous research to date has used curcumin in a hydrolysed (drinkable) format. The aim of this study is to investigate whether hydrolysed curcumin can reduce indices of muscle damage and improve recovery, whilst also examining a potential dose-response effect.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Status
unknown

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

First Submitted

Initial submission to the registry

April 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

April 12, 2022

Last Update Submit

April 19, 2022

Conditions

Exercise Induced Muscle Damage

Outcome Measures

Primary Outcomes (40)

  • Blood markers

    Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken

    Baseline

  • Blood markers

    Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken

    immediately post muscle damage intervention

  • Blood markers

    Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken

    24 hours post

  • Blood markers

    Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken

    48 hours post

  • Blood markers

    Blood samples will be taken for analysis of markers of IL-6, IL-1β, TNF-α, IL-1, IL-4, IL-10 and CK will be taken

    72 hours post

  • Ford and Fort

    Capillary sample Ford and Fort tests

    Baseline

  • Ford and Fort

    Capillary sample Ford and Fort tests

    Immediately post muscle damage intervention

  • Ford and Fort

    Capillary sample Ford and Fort tests

    24 hours post

  • Ford and Fort

    Capillary sample Ford and Fort tests

    48 hours post

  • Ford and Fort

    Capillary sample Ford and Fort tests

    72 hours post

  • Soreness

    Perceived muscle soreness scale - Visual analouge scale

    Baseline

  • Soreness

    Perceived muscle soreness scale - Visual analouge scale

    Immediately post muscle damage intervention

  • Soreness

    Perceived muscle soreness scale - Visual analouge scale

    24 hours post

  • Soreness

    Perceived muscle soreness scale - Visual analouge scale

    48 hours post

  • Soreness

    Perceived muscle soreness scale - Visual analouge scale

    72 hours post

  • Soreness

    BORG CR-10 scale

    Baseline

  • Soreness

    BORG CR-10 scale

    Immediately post muscle damage intervention

  • Soreness

    BORG CR-10 scale

    24 hours post

  • Soreness

    BORG CR-10 scale

    48 hours post

  • Soreness

    BORG CR-10 scale

    72 hours post

  • Soreness

    Pressure pain threshold

    Baseline

  • Soreness

    Pressure pain threshold

    Immediately post muscle damage intervention

  • Soreness

    Pressure pain threshold

    24 hours post

  • Soreness

    Pressure pain threshold

    48 hours post

  • Soreness

    Pressure pain threshold

    72 hours post

  • Muscle Structure

    Muscle swelling - thigh girth + Ultrasound measurement

    Baseline

  • Muscle Structure

    Muscle swelling - thigh girth + Ultrasound measurement

    Immediately post muscle damage intervention

  • Muscle Structure

    Muscle swelling - thigh girth + Ultrasound measurement

    24 hours post

  • Muscle Structure

    Muscle swelling - thigh girth + Ultrasound measurement

    48 hours post

  • Muscle Structure

    Muscle swelling - thigh girth + Ultrasound measurement

    72 hours post

  • Muscle Function

    maximal strength

    Baseline

  • Muscle Function

    maximal strength

    Immediately post muscle damage intervention

  • Muscle Function

    maximal strength

    24 hours post

  • Muscle Function

    maximal strength

    48 hours post

  • Muscle Function

    maximal strength

    72 hours post

  • Muscle Function

    Muscular endurance

    Baseline

  • Muscle Function

    Muscular endurance

    Immediately post muscle damage intervention

  • Muscle Function

    Muscular endurance

    24 hours post

  • Muscle Function

    Muscular endurance

    48 hours post

  • Muscle Function

    Muscular endurance

    72 hours post

Study Arms (3)

Curcumin Single

EXPERIMENTAL

The Single dose group will consume 1 placebo sachet and one curcumin sachet per day. Curcumin supplementation will be from YourZooki, the supplement in question is commercially offered to the public in a tangerine flavour. The sachets will be in 750mg hydrolysed format. The placebo is a sachet containing the same ingredients mentioned above minus the curcumin. The sachets will be in 750mg hydrolysed format. Supplementation will be administered and commence 48-hours prior to the first testing day and will be consumed twice a day (8am \& 8pm).

Dietary Supplement: Curcumin

Curcumin Double

EXPERIMENTAL

The double dose group will consume two sachets per day of curcumin. Curcumin supplementation will be from YourZooki, the supplement in question is commercially offered to the public in a tangerine flavour. The sachets will be in 750mg hydrolysed format. Supplementation will be administered and commence 48-hours prior to the first testing day and will be consumed twice a day (8am \& 8pm).

Dietary Supplement: Curcumin

Placebo

NO INTERVENTION

Placebo sachets containing the same ingredients mentioned above minus the curcumin. The sachets will be in 750mg hydrolysed format. Participants will consume two sachets per day. Supplementation will be administered and commence 48-hours prior to the first testing day and will be consumed twice a day (8am \& 8pm).

Interventions

CurcuminDIETARY_SUPPLEMENT

Curcumin Supplementation

Curcumin DoubleCurcumin Single

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between the age of 18-35
  • non-smoker
  • no previous history of cardiovascular, respiratory, or neurological problems
  • not taking anticoagulant medication
  • injury-free in the 3 months prior to scheduled participation in the study

You may not qualify if:

  • hypertension (\<140/80)
  • any blood diseases or clotting issues,
  • injury, or previous injury in \<3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Luke Hughes, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

  • Jess Hill, PhD

    St. Mary's University, Twickenham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luke Hughes, PhD

CONTACT

+447920004214luke4.hughes@northumbria.ac.uk

Ian Grant, MSc

CONTACT

020 8240 4000ian.grant@stmarys.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 26, 2022

Study Start

May 1, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2023

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share