Phyllantus Amarus for the Protection of Liver Health

Biotropics Malaysia Berhad

Status and phase

Completed

Phase 2

Conditions

Healthy

Treatments

Other: Placebo

Dietary Supplement: Phyllantus amarus

Study type

Interventional

Funder types

Industry

Identifiers

NCT03349697

BIOT1200

Details and patient eligibility

About

This study is a randomized, double-blind, placebo controlled crossover study. The purpose of this study is to assess the ability of Phyllantus amarus to protect the liver against temporary stress including oxidative stress induced by alcohol consumption.

Enrollment

15 patients

Sex

All

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male or female 21-50 years of age, inclusive.
Subject consumes at least 5 servings of alcohol per week on a regular basis.
Minimum POMS score of 15.
Access to a computer and internet
Subject is willing to maintain his or her habitual food and beverage intake (other than substitution of study food for similar products) and physical activity patterns throughout the study period.
Body mass index (BMI) between 20 and 30 kg/m2.
Subject is willing and able to comply with the alcohol consumption requirements.
Subjects willing to stay in the clinic for two overnight stays
Judged by the Investigator to be in general good health on the basis of medical history.
Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

Exclusion criteria

Any Liver condition including Hepatitis, Fatty Liver, Liver Disease.
Liver Function greater than three times the upper level limit of normal
History or record of aggressive or violent behavior
Any significant GI condition that would potentially interfere with the evaluation of the study product [e.g., Ulcerative Colitis or Crohn's Disease, inflammatory bowel disease, irritable bowel syndrome, Clinically significant Gastritis, history of upper GI bleed (bleeding ulcer), chronic constipation (defined as <3 bowel movements per week), history of frequent diarrhea, history of surgery for weight loss, gastroparesis, clinically important lactose intolerance].
Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, or biliary disorder.
Known allergy or sensitivity to any ingredients in the study products.
Extreme dietary habits (e.g., vegan, Atkins Diet, etc.).
Recent (within two weeks of visit 1, week -1) episode of acute gastrointestinal illness such as nausea, vomiting, or diarrhea.
Uncontrolled hypertension (systolic blood pressure _160 mm Hg or diastolic blood pressure _100 mm Hg at visit 1, week -1).
History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
Any major trauma or surgical event within three months of visit 1, week -1.
Recent use of antibiotics (within 6 weeks).
Females who are pregnant, lactating, planning to be pregnant during the study period.
Recent history of (within 12 months) or strong potential for alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink =12 ounces beer, 5 ounces wine, or 1 ½ ounces distilled spirits).
Participation in a clinical study with exposure to any non-registered drug product within 30 days prior.
Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
Current active respiratory illness at the time of screening
Any immune system disorders
Subjects with a history of perforation of the stomach or intestines
Subjects who have had gastric bypass surgery
Untreated Hypothyroidism
Subjects with active eating disorder including anorexia nervosa, bulimia, and/or obsessive compulsive eating disorders
Spinal cord injuries