SupplementNCT07777510
Black Elderberry Supplementation and Exercise Responses in Young Men
A study testing Anthocyanin Group in people with Supplement, run by Kocatepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 27 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Supplement
- What is being tested?
- Anthocyanin Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2024to 27 Jul 2024
- 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 18 to 27 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocatepe University
Afyonkarahisar, Afyonkarahisar, 03030
About this study
Official title: Effects of Black Elderberry Supplementation on Blood Lactate Responses and Oxidative Stress Biomarkers in Young Men: A Randomized, Placebo-Controlled Trial
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.
- Conditions
- Supplement
- Being tested
- Anthocyanin Group, Placebo Group
- Keywords
- Black elderberry, Anthocyanin supplementation, Blood lactate, Oxidative stress, Exercise performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthocyanin GroupDietary supplement
Participants received 300 mg black elderberry (Sambucus nigra L.) extract capsules according to the study protocol.
Placebo GroupDietary supplement
Participants received placebo capsules containing maltodextrin according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Anthocyanin Group |
| Placebo Group | Placebo comparator | Participants received placebo capsules identical in appearance and administration schedule to the black elderberry capsules. Receives: Dietary Supplement: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start6 May 2024
- Primary completion27 Jul 2024
- Study completion27 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SupplementStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocatepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Burdur Mehmet Akif Ersoy University
- Responsible party
- Principal investigator, Hilal Ertürk Yaşar, Kocatepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777510
- Sponsor's protocol ID
- 0909-DR-23
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Black Elderberry Supplementation on Blood Lactate Responses and Oxidative Stress Biomarkers in Young Men: A Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07777510
- Acronym / sponsor ID
- 0909-DR-23
- Conditions
- Supplement
- Keywords
- Black elderberry, Anthocyanin supplementation, Blood lactate, Oxidative stress, Exercise performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Kocatepe UniversityUniversity, hospital or other
- Collaborators
- Burdur Mehmet Akif Ersoy University
- Study start
- 6 May 2024 (actual)
- Primary completion
- 27 Jul 2024 (actual)
- Study completion
- 27 Jul 2024 (actual)
- First posted
- 20 Aug 2026 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anthocyanin Group | Experimental | Dietary Supplement: Anthocyanin GroupParticipants received black elderberry (Sambucus nigra L.) supplementation according to the study protocol, including single-dose, alternate-day, and daily supplementation phases. |
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo GroupParticipants received placebo capsules identical in appearance and administration schedule to the black elderberry capsules. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Anthocyanin GroupParticipants received 300 mg black elderberry (Sambucus nigra L.) extract capsules according to the study protocol. | Dietary supplement | Anthocyanin Group |
| Placebo GroupParticipants received placebo capsules containing maltodextrin according to the study protocol. | Dietary supplement | Placebo Group |
Primary outcome
Catalase (CAT) Activity
Time frame: 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).
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.
Glutathione (GSH) Level
Time frame: 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).
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
Malondialdehyde (MDA)
Time frame: 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).
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.
Superoxide Dismutase (SOD) Activity
Time frame: 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).
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.
Nitric Oxide (NO)
Time frame: 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).
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.
Blood Lactate Concentration
Time frame: 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.
Blood lactate concentration measured from capillary blood samples using a portable lactate analyzer (EDGE).
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 20 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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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 Anthocyanin Group in people with Supplement, run by Kocatepe University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 20 Aug 2026. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Catalase (CAT) Activity (time frame: 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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.