Retinoic Acid Supplementation and Subjects With Hypercholesterolemia

NCT02497833 | Completed Early Phase 1 DMC

• 1 other identifier: ZXYZM-2
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the effects of retinoic acid on the HDL-PON1 activity and cholesterol efflux capacity in hypercholesterolemic subjects.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• PON1 activity

  PON1 activity is assayed in HDL isolated from plasma of subjects from the placebo and retinoic acid groups by using UV spectrophotometry in a 96-well plate format using phenyl acetate or paraoxon as substrates.

  changes from baseline in PON1 activity at 12 weeks

Secondary Outcomes (1)

• Lp-PLA2 activity

  changes from baseline in Lp-PLA2 activity at 12 weeks

Other Outcomes (1)

• cholesterol efflux capacity

  changes from baseline in cholesterol efflux capacity at 12 weeks

Study Arms (2)

control

PLACEBO COMPARATOR

the participants in this arm are instruted to consume placebo capsules

Other: placebo

treatment

EXPERIMENTAL

the participants in this arm are instruted to consume retinoic acid capsules

Dietary Supplement: retinoic acid

Interventions

retinoic acid DIETARY_SUPPLEMENT

During the trial period, the participants are instructed to consume retinoic acid capsules twice daily (30 min after breakfast and supper).The retinoic acid capsules provided a total daily intake of 10 mg of retinoic acid.

treatment

placebo OTHER

During the trial period, the participants are instructed to consume placebo capsules twice daily (30 min after breakfast and supper).The placebo capsules are composed of starch and pigment.

control

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subject has a fasting total cholesterol concentration between 200 and 310mg/dl.
• subject is between 25 and 65 years of age, inclusive.
• subjects' BMI is between 18.5 kg/m2 and 35 kg/m2.

You may not qualify if:

• subject that is pregnant.
• subject that has coronafy artery desease, diabetes mellitus, thyroid disorders, mental disorder, cancer, cirrhosis, renal disease and hepatic desease.
• subject that has had operation less than six months prior to screening visit.
• subject that is smoking.
• subject uses any drugs that could influence the measurement of lipid paramerters or inflammatiory makers.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Min Xia, PhD

  Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 15, 2015
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

CN (1)