NCT07777510

Brief Summary

his randomized, placebo-controlled trial investigated whether black elderberry (Sambucus nigra L.) supplementation affects blood lactate responses, oxidative stress biomarkers, and exercise-related physiological responses in young men who regularly exercise. Participants completed four assessment sessions: a pre-test and three supplementation phases involving a single dose, alternate-day supplementation for 14 days, and daily supplementation for 14 days. The anthocyanin group received black elderberry supplementation, while the control group received an identical placebo. Blood lactate, oxidative stress biomarkers, body composition, and exercise performance were assessed under standardized laboratory conditions across the study phases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

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

May 6, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 13, 2026

Last Update Submit

August 17, 2026

Conditions

Keywords

Black elderberryAnthocyanin supplementationBlood lactateOxidative stressExercise performance

Outcome Measures

Primary Outcomes (6)

  • Catalase (CAT) Activity

    Plasma catalase (CAT) activity was assessed at the pre-test and at the end of each supplementation phase. At the pre-test, venous blood was collected before the exercise protocol. During each supplementation phase, venous blood was collected 15 minutes after completion of the exercise protocol. In each supplementation phase, the final dose was administered approximately 2 hours before the exercise test. CAT activity was measured using a commercial ELISA kit (BT-LAB, Bioassay Technology Laboratory, Zhejiang, China) and reported in nmol/min/mL.

    Pre-test (before the exercise protocol) and 15 minutes after the exercise protocol at the end of each supplementation phase (single-dose, 14-day alternate-day, and 14-day daily supplementation).

  • Glutathione (GSH) Level

    Plasma glutathione (GSH) level was assessed at the pre-test and at the end of each supplementation phase. At the pre-test, venous blood was collected before the exercise protocol. During each supplementation phase, venous blood was collected 15 minutes after completion of the exercise protocol. In each supplementation phase, the final dose was administered approximately 2 hours before the exercise test. GSH level was measured using a commercial ELISA kit (BT-LAB, Bioassay Technology Laboratory, Zhejiang, China) and reported in µmol/g

    Pre-test (before the exercise protocol) and 15 minutes after the exercise protocol at the end of each supplementation phase (single-dose, 14-day alternate-day, and 14-day daily supplementation).

  • Malondialdehyde (MDA)

    Plasma malondialdehyde (MDA) concentration was assessed at the pre-test and at the end of each supplementation phase. At the pre-test, venous blood was collected before the exercise protocol. During each supplementation phase, venous blood was collected 15 minutes after completion of the exercise protocol. In each supplementation phase, the final dose was administered approximately 2 hours before the exercise test. MDA concentration was measured using a commercial ELISA kit (BT-LAB, Bioassay Technology Laboratory, Zhejiang, China) and reported in nmol/mL.

    Pre-test (before the exercise protocol) and 15 minutes after the exercise protocol at the end of each supplementation phase (single-dose, 14-day alternate-day, and 14-day daily supplementation).

  • Superoxide Dismutase (SOD) Activity

    Plasma superoxide dismutase (SOD) activity was assessed at the pre-test and at the end of each supplementation phase. At the pre-test, venous blood was collected before the exercise protocol. During each supplementation phase, venous blood was collected 15 minutes after completion of the exercise protocol. In each supplementation phase, the final dose was administered approximately 2 hours before the exercise test. SOD activity was measured using a commercial ELISA kit (BT-LAB, Bioassay Technology Laboratory, Zhejiang, China) and reported in U/mL.

    Pre-test (before the exercise protocol) and 15 minutes after the exercise protocol at the end of each supplementation phase (single-dose, 14-day alternate-day, and 14-day daily supplementation).

  • Nitric Oxide (NO)

    Plasma nitric oxide (NO) concentration was assessed at the pre-test and at the end of each supplementation phase. At the pre-test, venous blood was collected before the exercise protocol. During each supplementation phase, venous blood was collected 15 minutes after completion of the exercise protocol. In each supplementation phase, the final dose was administered approximately 2 hours before the exercise test. NO concentration was measured using a commercial ELISA kit (BT-LAB, Bioassay Technology Laboratory, Zhejiang, China) and reported in µmol/L.

    Pre-test (before the exercise protocol) and 15 minutes after the exercise protocol at the end of each supplementation phase (single-dose, 14-day alternate-day, and 14-day daily supplementation).

  • Blood Lactate Concentration

    Blood lactate concentration measured from capillary blood samples using a portable lactate analyzer (EDGE).

    Baseline (pre-test), during the 3rd minute of exercise, immediately post-exercise, and 30 minutes post-exercise during recovery; measurements repeated after Baseline (pre-test), single-dose, alternate-day, and daily supplementation phases.

Study Arms (2)

Anthocyanin Group

EXPERIMENTAL

Participants received black elderberry (Sambucus nigra L.) supplementation according to the study protocol, including single-dose, alternate-day, and daily supplementation phases.

Dietary Supplement: Anthocyanin Group

Placebo Group

PLACEBO COMPARATOR

Participants received placebo capsules identical in appearance and administration schedule to the black elderberry capsules.

Dietary Supplement: Placebo Group

Interventions

Anthocyanin GroupDIETARY_SUPPLEMENT

Participants received 300 mg black elderberry (Sambucus nigra L.) extract capsules according to the study protocol.

Anthocyanin Group
Placebo GroupDIETARY_SUPPLEMENT

Participants received placebo capsules containing maltodextrin according to the study protocol.

Placebo Group

Eligibility Criteria

Age18 Years - 27 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male participants aged 18-27 years.
  • Engaged in regular exercise at least three times per week during the previous three months.
  • No history of cardiovascular, metabolic, or endocrine disease.
  • No use of dietary supplements during the preceding month.
  • Provided written informed consent before participation.

You may not qualify if:

  • Known allergy or intolerance to black elderberry or other berry-based supplements.
  • Serious musculoskeletal injury or surgery within the previous six months.
  • Failure to comply with the study protocol.
  • Development of any health problem that prevented continuation of the exercise protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocatepe University

Afyonkarahisar, Afyonkarahisar, 03030, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 13, 2026

First Posted

August 20, 2026

Study Start

May 6, 2024

Primary Completion

July 27, 2024

Study Completion

July 27, 2024

Last Updated

August 20, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers to protect participants' privacy and confidentiality. The findings of the study will be reported only in aggregated and anonymized form.

Locations