Phyllantus amarus for the protection of liver health

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 15

Inclusion Criteria

1. Healthy male or female 21-50 years of age, inclusive
2. Subject consumes at least five servings of alcohol per week on a regular basis. Liquor vs wine or beer
3. Minimum Profile of Mood States (POMS) score of 15
4. Access to a computer and internet
5. 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
6. Body mass index (BMI) between 20 and 30 kg/m2
7. Subject is willing and able to comply with the alcohol consumption requirements
8. Subjects willing to stay in the clinic for two overnight stays
9. Generally healthy
10. Agree to all visits and study procedures

Exclusion Criteria

1. Any liver condition including hepatitis B, hepatitis C, fatty liver and liver disease
2. Liver function greater than three times the upper level limit of normal
3. History or record of aggressive or violent behavior
4. Evidence of liver disease
5. Presence of ascites
6. Family history of alcoholism
7. Any significant gastrointestinal (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, celiac disease, gastroesophageal reflux disease (GERD), 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]
8. Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, or biliary disorder
9. Known allergy or sensitivity to any ingredients in the study products
10. Extreme dietary habits (e.g., vegan, Atkins Diet, etc.)
11. Recent (within two weeks of visit 1, week -1) episode of acute gastrointestinal illness such as nausea, vomiting, or diarrhea
12. Uncontrolled hypertension (systolic blood pressure _160 mm Hg or diastolic blood pressure _100 mm Hg at visit 1, week -1)
13. History or presence of cancer in the prior two years, except for non-melanoma skin cancer
14. Any major trauma or surgical event within three months of visit 1, week -1
15. Recent use of antibiotics (within 6 weeks)
16. Females who are pregnant, lactating, planning to be pregnant during the study period
17. Recent history of (within 12 months) or strong potential for alcohol or substance abuse
18. Alcohol abuse will be defined as >14 drinks per week (1 drink =12 ounces beer, 5 ounces wine, or 1 ½ ounces distilled spirits)
19. Participation in a clinical study with exposure to any non-registered drug product within 30 days prior
20. 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
21. Current active respiratory illness at the time of screening
22. Any immune system disorders
23. Subjects with a history of perforation of the stomach or intestines
24. Subjects who have had gastric bypass surgery
25. Untreated hypothyroidism
26. Subjects with active eating disorder including anorexia nervosa, bulimia, and/or obsessive compulsive eating disorders
27. Spinal cord injuries

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. High Sensitivity C-reactive Protein (HS CRP)<br>2. Inflammatory Cytokine Panel [including TNF alpha, IL-1Beta, IL-2 , IL-4 , IL-5, IL-6 , IL-7, IL-8, IL-10 , IL-12p70, IL-13 , IL-17A, TNF-alpha , G-CSF , Eotaxin, MIP1Beta, IFNgamma, VEGF, MCP- 1, FGF-BASIC, GM-CSF]<br>3. Liver function tests [AST and ALT, total bilirubin, albumin, International Normalized ratio (INR), aspartate amino transferase, alanine amino transferase and alkaline phosphatase]

Secondary Outcome Measures

Name	Time	Method
1. Hangover severity score: 7-point scale from none (0) to six (6). Healthy subjects should have a score of 0<br>2. Profile of Mood States (POMS) <br>3. Cognitive performance tests (CNS Vital Signs System)<br>4. Sleep Quality Scale