Safety Evaluation of β-arbutin in Healthy Human Subjects

SP Nutraceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Dietary Supplement: Beta-arbutin

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03868748

241603

Details and patient eligibility

About

The purpose of this study is to determine the safety of synthetic beta-arbutin, a dietary supplement that aids in the prevention and treatment of calcium oxalate kidney stones, when administered to healthy human subjects.

Full description

The objective and purpose of this Phase I study is to investigate the safety of synthetic beta-arbutin, administered to healthy human subjects for: i) 12 weeks, at a dose of 150 mg/day, and ii) 4 weeks, at a dose of 400mg/day. Safety will be determined by assessing adverse event rates between treatment groups and mean changes relative to baseline in serum biochemical, hematological and urinary markers.

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults, aged 18-65 years
• includes non-pregnant, non-breastfeeding women on adequate birth control
• acceptable effective contraceptive methods for participants with child-bearing potential include: barrier methods (condoms), total abstinence, hormonal birth control methods (oral, injectable, transdermal, or intra-vaginal), intrauterine devices, and confirmed successful vasectomy of partner;
• Body Mass Index (BMI) of 18.5-35 kg/m2;
• Generally healthy (absence of active clinical disease as determined by serum biochemical, hematological, and urinary parameter tests as well as detailed medical history and blood pressure measurements) as assessed by the PI/QI;
• Males and females of childbearing potential willing to use appropriate effective contraception for the duration of the study;
• Agrees to maintain current diet and exercise routine during the study;
• Ability to provide written informed consent; and
• Willing to comply with all study requirements and provide urine and blood specimens over the 12-week study period..

Exclusion criteria

• Pregnant or breastfeeding women;
• History of renal dysfunction;
• History of macular degeneration as assessed by the PI/QI;
• History of liver disease as assessed by the PI/QI;
• Type I or Type II diabetes;
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the PI/QI History of renal dysfunction, as assessed by the PI/QI;
• Cancer being actively treated with systemic therapy (i.e. chemotherapy, immune therapy);
• Self-reported HIV-, Hepatitis B-, and/or C-positive diagnosis;
• High alcohol intake (average of > 2 standard drinks per day);
• Heavy smokers (average of >10 cigarettes per day);
• Use of cannabinoid products within 30 days of enrollment;
• Any history of major surgery (i.e. inter-abdominal, inter-thoracic, inter-cranial) within the last six months, or surgery planned during the course of the study;
• Known hypersensitivity to arbutin;
• Allergy to all ingredients (including non-medicinal ingredients) in investigational products and placebo product
• Self-reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation; and
• Clinically significant abnormal laboratory results at screening as assessed by the PI/QI

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

39 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The double-blind phase of the study starts with randomized allocation of eligible participants to one of three treatment arms. Participants randomized to the placebo treatment arm will consume one placebo capsule per day for 12 weeks

Treatment:

Other: Placebo

Low Dose, 12 weeks

Experimental group

Description:

The double-blind phase of the study starts with randomized allocation of eligible participants to one of three treatment arms. Participants randomized to the low dose treatment arm will consume one 150 mg beta-arbutin capsule per day for 12 weeks.

Treatment:

Other: Placebo

Dietary Supplement: Beta-arbutin

High Dose, 4 weeks

Experimental group

Description:

The double-blind phase of the study starts with randomized allocation of eligible participants to one of three treatment arms. Participants randomized to the high dose treatment arm will consume one placebo capsule per day for 8 weeks followed by one 400 mg beta-arbutin capsule per day for 4 weeks.

Treatment:

Other: Placebo

Dietary Supplement: Beta-arbutin