HealthyNCT02760511
Anthocyanin Dose-escalation Study in Healthy Young Adults
A study testing Anthocyanin in people with Healthy, run by Shaoguan University at 1 site in China.
Trial summary
Anthocyanins are naturally existing, polyphenolic compounds found in the vacuolar sap of the epidermal tissues of flowers and fruits, with a pink, red, blue, or purple color. Recently, study of anthocyanin pigments has drawn more and more interest since several epidemiological studies have demonstrated their… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Anthocyanin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2016to 1 May 2017
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Blood test, liver function test, renal function test are normal;
- Blood lipids, cardiac function are normal;
- 18.5<BMI<23.9;
- Regular dietary, seldomly eating outside;
- Stable condition of body weight in recent 3 months
Who cannot join
- > 140 grams of alcohol/week for male and >70 grams of alcohol/week for female, smoking regularly;
- Known diagnosis of acute diseases or chronic diseases in recent 1 month;
- Be planning to be pregnant in a year, or being pregnant and lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anthocyanin Dose-escalation Study in Healthy Young Adults: A CONSORT-compliant, Randomized, Controlled Trial
Anthocyanins are naturally existing, polyphenolic compounds found in the vacuolar sap of the epidermal tissues of flowers and fruits, with a pink, red, blue, or purple color. Recently, study of anthocyanin pigments has drawn more and more interest since several epidemiological studies have demonstrated their health-promoting properties, such as reducing lipid accumulation and decreasing oxidative stress and inflammation. Nevertheless, there is a clear need for advancing understanding with regard to effective amounts of intake for these phytochemicals. The aim of this study was to investigate the efficacy and pharmacokinetics of anthocyanin in healthy volunteers.
- Conditions
- Healthy
- Being tested
- Anthocyanin, Placebo
- Keywords
- Randomized Controlled Trial, Anthocyanin, Antioxidants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthocyaninDietary supplement
Capsules with different anthocyanin content
PlaceboDietary supplement
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Intake of placebo capsules Receives: Dietary Supplement: Placebo |
| 20 mg | Active comparator | Daily intake of 20 mg anthocyanin Receives: Dietary Supplement: Anthocyanin |
| 40 mg | Active comparator | Daily intake of 40 mg anthocyanin Receives: Dietary Supplement: Anthocyanin |
| 80 mg | Active comparator | Daily intake of 80 mg anthocyanin Receives: Dietary Supplement: Anthocyanin |
| 160 mg | Active comparator | Daily intake of 160 mg anthocyanin Receives: Dietary Supplement: Anthocyanin |
| 320 mg | Active comparator | Daily intake of 320 mg anthocyanin Receives: Dietary Supplement: Anthocyanin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma total antioxidant capacity
Oxidative stress
Measured: 2 weeks
Plasma malondialdehyde concentrations
Oxidative stress
Measured: 2 weeks
Plasma 8-iso-prostaglandin concentrations
Oxidative stress
Measured: 2 weeks
Secondary outcomes (2)
Plasma tumor necrosis factor alpha concentrations
Inflammatory response
Measured: 2 weeks
Plasma interleukin-6 concentrations
Inflammatory response
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start1 Feb 2016
- Primary completion1 Sep 2016
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaoguan University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760511
- Sponsor's protocol ID
- SGU-04
- Status last verified
- Apr 2016
- First submitted
- 13 Apr 2016
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthocyanin Dose-escalation Study in Healthy Young Adults: A CONSORT-compliant, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02760511
- Acronym / sponsor ID
- SGU-04
- Conditions
- Healthy
- Keywords
- Randomized Controlled Trial, Anthocyanin, Antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Shaoguan UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 3 May 2016 (estimated)
- 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.
Anthocyanins are naturally existing, polyphenolic compounds found in the vacuolar sap of the epidermal tissues of flowers and fruits, with a pink, red, blue, or purple color. Recently, study of anthocyanin pigments has drawn more and more interest since several epidemiological studies have demonstrated their health-promoting properties, such as reducing lipid accumulation and decreasing oxidative stress and inflammation. Nevertheless, there is a clear need for advancing understanding with regard to effective amounts of intake for these phytochemicals. The aim of this study was to investigate the efficacy and pharmacokinetics of anthocyanin in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: PlaceboIntake of placebo capsules |
| 20 mg | Active comparator | Dietary Supplement: AnthocyaninDaily intake of 20 mg anthocyanin |
| 40 mg | Active comparator | Dietary Supplement: AnthocyaninDaily intake of 40 mg anthocyanin |
| 80 mg | Active comparator | Dietary Supplement: AnthocyaninDaily intake of 80 mg anthocyanin |
| 160 mg | Active comparator | Dietary Supplement: AnthocyaninDaily intake of 160 mg anthocyanin |
| 320 mg | Active comparator | Dietary Supplement: AnthocyaninDaily intake of 320 mg anthocyanin |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Blood test, liver function test, renal function test are normal;
- Blood lipids, cardiac function are normal;
- 18.5<BMI<23.9;
- Regular dietary, seldomly eating outside;
- Stable condition of body weight in recent 3 months
Key exclusion criteria (3 listed)
- > 140 grams of alcohol/week for male and >70 grams of alcohol/week for female, smoking regularly;
- Known diagnosis of acute diseases or chronic diseases in recent 1 month;
- Be planning to be pregnant in a year, or being pregnant and lactation.
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 |
|---|---|---|
| AnthocyaninCapsules with different anthocyanin content | Dietary supplement | 160 mg, 20 mg, 320 mg, 40 mg, 80 mg |
| PlaceboPlacebo capsules | Dietary supplement | Control |
Primary outcome
Plasma total antioxidant capacity
Time frame: 2 weeks
Oxidative stress
Plasma malondialdehyde concentrations
Time frame: 2 weeks
Oxidative stress
Plasma 8-iso-prostaglandin concentrations
Time frame: 2 weeks
Oxidative stress
2 secondary outcomes
Plasma tumor necrosis factor alpha concentrations
Time frame: 2 weeks
Plasma interleukin-6 concentrations
Time frame: 2 weeks
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 25 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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 in people with Healthy, run by Shaoguan University at 1 site in China.
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 3 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 25 Mar 2019. 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 China. 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?
Plasma total antioxidant capacity (time frame: 2 weeks). The study lists 3 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 25 Mar 2019.