Dietary Anthocyanins Improve Lipid Metabolism in a Dose - Dependent Manner
NCT ID: NCT03415503
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
169 participants
INTERVENTIONAL
2018-10-01
2019-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
placebo
The placebo capsules only contained pullulan and maltodextrin.During the trial period, the participants were instructed to consume 2 Medox® placebo capsules twice daily (30 min after breakfast or supper).
Medox® Anthocyanin capsules
Subjects were orally administered Medox® capsules daily for 12 weeks.
40mg/d anthocyanins
Medox® Anthocyanin capsules is consisted of 17 different natural purified anthocyanins.from bilberry (Vaccinium myrtillus) and black currant (Ribesnigrum). To achieve the double-blind,every group are instructed to consume the same amount of capsule. During the trial period, the participants will be instructed to consume one Medox® anthocyanin capsules and one Medox® placebo capsules 30 min after breakfast and consume two Medox® placebo capsules 30 min after supper.The anthocyanin capsules (40 mg anthocyanins per capsule) will provid a total daily intake of 40 mg anthocyanins.
Medox® Anthocyanin capsules
Subjects were orally administered Medox® capsules daily for 12 weeks.
80mg/d anthocyanins
Medox® Anthocyanin capsules is consisted of 17 different natural purified anthocyanins.from bilberry (Vaccinium myrtillus) and black currant (Ribesnigrum).To achieve the double-blind,every group are instructed to consume the same amount of capsule. During the trial period, the participants will be instructed to consume one Medox® anthocyanin capsules and one Medox® placebo capsules 30 min after breakfast and consume two Medox® placebo capsules 30 min after supper.The anthocyanin capsules (80 mg anthocyanins per capsule) will provid a total daily intake of 80 mg anthocyanins.
Medox® Anthocyanin capsules
Subjects were orally administered Medox® capsules daily for 12 weeks.
320mg/d anthocyanins
Medox® Anthocyanin capsules is consisted of 17 different natural purified anthocyanins.from bilberry (Vaccinium myrtillus) and black currant (Ribesnigrum).To achieve the double-blind,every group are instructed to consume the same amount of capsule. During the trial period, the participants will be instructed to consume two Medox® anthocyanin capsules 30 min after breakfast and after supper.The anthocyanin capsules (80 mg anthocyanins per capsule,4 per day) will provid a total daily intake of 320 mg anthocyanins.
Medox® Anthocyanin capsules
Subjects were orally administered Medox® capsules daily for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Medox® Anthocyanin capsules
Subjects were orally administered Medox® capsules daily for 12 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects with dyslipidemia who also have prediabetes
* The age between 35 and 70 years old
Exclusion Criteria
* dietary supplementation with phytochemicals including anthocyanins in the preceding 2 months
* history of acute or chronic infectious disease, autoimmune disease, cancer, traumatic injury, or surgery in the preceding 1 month
* history of severe chronic disease including AS and CVD, liver or renal dysfunction, and lactation or pregnancy
* Pregnant woman and Breast Feeding Women
35 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhanghy
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ling W H, Pro
Role: STUDY_CHAIR
Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zhao Y, Xu H, Tian Z, Wang X, Xu L, Li K, Gao X, Fan D, Ma X, Ling W, Yang Y. Dose-dependent reductions in plasma ceramides after anthocyanin supplementation are associated with improvements in plasma lipids and cholesterol efflux capacity in dyslipidemia: A randomized controlled trial. Clin Nutr. 2021 Apr;40(4):1871-1878. doi: 10.1016/j.clnu.2020.10.014. Epub 2020 Oct 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
lingwh87331597
Identifier Type: -
Identifier Source: org_study_id