Dietary Anthocyanins Improve Lipid Metabolism in a Dose - Dependent Manner

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Dyslipidemias

Treatments: Drug: Medox® Anthocyanin capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT03415503

lingwh87331597

Details and patient eligibility

About

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.

Full 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.

Enrollment: 169 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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169 participants in 4 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Medox® Anthocyanin capsules

40mg/d anthocyanins

Experimental group

Description:

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.

Treatment:

Drug: Medox® Anthocyanin capsules

80mg/d anthocyanins

Experimental group

Description:

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.

Treatment:

Drug: Medox® Anthocyanin capsules

320mg/d anthocyanins

Experimental group

Description:

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.

Treatment:

Drug: Medox® Anthocyanin capsules