Dietary Anthocyanins Improve Lipid Metabolism in a Dose - Dependent Manner
- Conditions
- Dyslipidemias
- Interventions
- Drug: Medox® Anthocyanin capsules
- Registration Number
- NCT03415503
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 169
- Dyslipidemia
- Subjects with dyslipidemia who also have prediabetes
- The age between 35 and 70 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Medox® Anthocyanin capsules 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). 40mg/d anthocyanins Medox® Anthocyanin capsules 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. 80mg/d anthocyanins Medox® Anthocyanin capsules 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. 320mg/d anthocyanins Medox® Anthocyanin capsules 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.
- Primary Outcome Measures
Name Time Method Anthocyanins dose-dependently improved blood lipids in patients with dyslipidemia. 12 weeks After 12 weeks intervention of anthocyanins, serum lipid profiles were measured at baseline, at 6 weeks, and at the end of 12 weeks.
- Secondary Outcome Measures
Name Time Method Anthocyanin supplementation improves cholesterol efflux capacity in a dose-response manner in subjects with dyslipidemia 12 weeks After 12 weeks intervention of anthocyanins,cholesterol efflux capacity (CEC) were measured at baseline, at 6 weeks, and at the end of 12 weeks.
Anthocyanins supplementation improve anti-oxidative and anti-inflammation capacity in a dose-response manner in subjects with dyslipidemia. 12 weeks After 12 weeks intervention of anthocyanins,Urine 8-iso-prostaglandinF2α (8-iso-PGF2α), 8-hydroxy-2'-deoxyguanosine (8-OHdG) and serum malondialdehyde (MDA), superoxide dismutase (SOD), UA (urine acid), interleukin-6 (IL-6), interleukin-10(IL-10), tumor necrosis factor-α (TNF-α) and C-reactive protein (CRP) were measured at baseline, at 6 weeks and at the end of 12 weeks.
Anthocyanins supplementation attenuate platelet hyperreactivity in a dose-response manner in subjects with dyslipidemia. 12 weeks After 12 weeks intervention of anthocyanins, platelet aggregation, the expression of P-selectin (CD62p) activated GPⅡbⅢa (PAC-1), platelet reactive oxygen species (ROS) and platelet mitochondrial membrane potential (TMRM) were measured at baseline, at 6 weeks and at the end of 12 weeks.
Trial Locations
- Locations (1)
Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China