A Study to Assess the Effect of the Natural Orange Extract in Individuals With Gastrointestinal Discomfort

A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to assess the Effect of the Natural Orange Extract in Individuals with Gastrointestinal Discomfort

Inclusion criteria

• Individuals willing to give written informed consent form voluntarily to participate in the study
• Healthy males and females of age between 18-65 years.
• Individuals with a Body Mass Index (BMI) between 18.5-29.9 kg/m2 (both values included).
• Individuals with a history of GI discomfort, associated with changes in the frequency and form of stools for the last 3 months, with symptom onset at least 6 months.
• Individuals with complaints of loose or watery stools, occurring in more than 25% of stools for the last 3 months.
• Individuals with consistent and stable body weight in the last 3 months prior to screening (less than 5% self-reported change).
• Individuals with a baseline score of less than or equal to 55 for the digestive domain score of the Gastrointestinal Quality of Life Index (GIQLI).
• Individuals with Fasting Blood Glucose (FBG) less than equal to 125 mg/dl.
• Individuals with systolic blood pressure (SBP) less than 140 and/or diastolic blood pressure (DBP) less than 90 mm Hg.
• Individuals willing to avoid consumption of citrus-based products during the entire study duration.
• Individuals willing to follow all the study procedures and follow-up visits as per protocol.

Exclusion criteria

• Individuals diagnosed with diabetes mellitus and are on active medication.
• Individuals diagnosed with hypertension and are on active medication.
• Individuals with thyroid dysfunction as assessed by Thyroid Stimulating Hormone (TSH) less than or equal to 0.4 or more than or equal to 5.0 mIU/L will be excluded.
• Individuals with a history and/or presence of acute or chronic significant GI disease or digestion/absorption disorders (e.g., Irritable bowel syndrome, inflammatory bowel disease, infectious diarrhea, coeliac disease, Clostridium difficile colitis, malabsorption, pancreatitis, disorders in digestive tract motility, gluten enteropathy, etc).
• Individuals with a history of autoimmune disorders.
• Individuals with major gastric, hepatic, biliary, pancreatic, or intestinal surgery within the last 6 months prior to screening or planned during the study (appendectomy, haemorrhoidectomy, or polypectomy allowed as long as occurred more than 3 months prior to screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred more than 3 months prior to screening).
• Any other relevant serious organ or systemic diseases (e.g., cardiovascular, respiratory, liver, renal, neurological disease, etc).
• Individuals with a history of malignancy within last five years.
• Use of immunosuppressive drugs within 3 months prior to the screening.
• Use of oral corticosteroids within 1 month prior to the screening.
• Excessive alcohol drinking (For men, consuming five or more drinks on any day or 15 or more per week; for women, consuming four or more on any day or 8 or more drinks per week). One unit of alcohol is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer.
• Individuals with a history of/known allergies to citrus fruits or citrus-based products.
• Individuals taking any antibiotics in the past 4 weeks and during the study.
• Individuals who are on regular intake of laxatives in the past 1 month prior to the screening.
• Individuals taking any dietary supplements, and medication for any gastrointestinal or metabolic disease (peptic ulcer, IBS, type-II diabetes, atherosclerosis, etc.)
• Individuals taking any hormones for any gastrointestinal or metabolic disease within 3 months prior to screening.
• Individuals taking any probiotics, prebiotics, post-biotics or synbiotics within 3 months prior to the screening.
• History of smoking or currently smoking.
• Individuals with gluten and/or lactose intolerance.
• Females who are pregnant/lactating or planning to be pregnant.
• Individuals who have participated in another clinical study(ies) with an IP within 90 days before screening, or who plan to participate in another study during the study period.
• Any other conditions, which in the opinion of the investigator may jeopardize the study.