Clinical trial NCT03415503: Dietary Anthocyanins Improve Lipid Metabolism in a Dose - Dependent Manner
Official title: Anthocyanin Supplementation Improves Blood Lipids in a Dose-response Manner in Subjects With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemias
Keywords: anthocyanins
dyslipidemias
dose response
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 169
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In order to study the effect of anthocyanins on the improvement of glucose and lipid metabolism, randomized intervention trials were conducted to compare the effects of anthocyanins on the improvement of glucose and lipid metabolism in different dose groups.To explore the best dose of anthocyanins for the prevention and treatment of anthocyanin metabolic diseases provide an important scientific basis.

Detailed description: In order to study the effect of anthocyanins on the improvement of glucose and lipid metabolism, randomized controlled trials were conducted to enrolled 300 patients with dyslipidemia. The subjects were divided into 0 mg / d, 40 mg / d, 80 mg / d, 320 mg/ d five dose groups, intervention for 12 weeks, comparing different doses of anthocyanins on glucose and lipid metabolism.To explore the best dose of anthocyanins for the prevention and treatment of anthocyanin metabolic diseases provide an important scientific basis.

Eligibility criteria: Inclusion Criteria:

* Dyslipidemia
* Subjects with dyslipidemia who also have prediabetes
* The age between 35 and 70 years old

Exclusion Criteria:

* intake of any medicine that affect lipid and glucose metabolism currently or in the preceding 6 months
* 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

Primary outcomes:
measure: Anthocyanins dose-dependently improved blood lipids in patients with dyslipidemia.
timeFrame: 12 weeks
Secondary outcomes:
measure: Anthocyanin supplementation improves cholesterol efflux capacity in a dose-response manner in subjects with dyslipidemia
timeFrame: 12 weeks
measure: Anthocyanins supplementation improve anti-oxidative and anti-inflammation capacity in a dose-response manner in subjects with dyslipidemia.
timeFrame: 12 weeks
measure: Anthocyanins supplementation attenuate platelet hyperreactivity in a dose-response manner in subjects with dyslipidemia.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
name: Ling W H, Pro
role: STUDY_CHAIR
References:
citation: 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.