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

NCT06658717 | Not Yet Recruiting

• 1 other identifier: HT/240501/CARD/GID
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Gut Health

Outcome Measures

Primary Outcomes (1)

• To assess the effect of the IP on gastrointestinal digestion symptoms as assessed by the change in digestive domain scores of the Gastrointestinal Quality of Life Index (GIQLI) compared to baseline and placebo.

  GIQLI is a validated tool suitable for assessing health-related quality of life (QOL) in clinical studies of individuals with gastrointestinal conditions and in routine clinical settings. It evaluates both generic and specific upper and lower gastrointestinal symptoms through 36 items. These questions are grouped into five domains: core symptoms (10 items), physical items (6 items), psychological items (6 items), social items (2 items) and disease-specific items (8 items). The GIQLI total cumulative score for the digestive domain ranges from 0 to 72, with higher scores indicating better gastrointestinal function and quality of life in the context of digestive symptoms

  Day 0, Day 45, Day 90.

Secondary Outcomes (9)

• To assess the effect of IP on the following compared to baseline and placebo Gastrointestinal quality of Life as assessed by GIQLI

  Day 0, Day 45, Day 90

• To assess the effect of IP on the following compared to baseline and placebo Stool consistency as assessed by the Bristol Stool Form Scale (BSFS)

  Day 0, Day 45, Day 90

• To assess the effect of IP on the following compared to baseline and placebo on Percentage responders as assessed by the change in the frequency of BSFS stool types 6 & 7

  Day 0, Day 45, Day 90

• To assess the effect of IP on the following compared to baseline and placebo on Gastrointestinal symptoms as assessed by the Gastrointestinal Symptoms Rating scale (GSRS)

  Day 0, Day 45, Day 90

• To assess the effect of IP on the compared to baseline and placebo Intestinal permeability as assessed by serum levels of Lipopolysaccharide binding protein (LBP)

  Day 0 & Day 90

Study Arms (2)

Group I: Investigational product (IP)

EXPERIMENTAL

One capsule to be taken with breakfast orally once a day

Dietary Supplement: Investigational product (IP): Natural orange extract

Placebo: Microcrystalline cellulose (MCC)

PLACEBO COMPARATOR

One capsule to be taken with breakfast orally once a day

Dietary Supplement: Group II: Placebo: Microcrystalline cellulose (MCC)

Interventions

Investigational product (IP): Natural orange extract DIETARY_SUPPLEMENT

Strength: 500 mg Dose regimen: One capsule to be taken with breakfast orally once a day

Group I: Investigational product (IP)

Group II: Placebo: Microcrystalline cellulose (MCC) DIETARY_SUPPLEMENT

Strength: 500 mg Dose regimen: One capsule to be taken with breakfast orally once a day

Placebo: Microcrystalline cellulose (MCC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (3)

Pawna Hospital

Pune, Maharashtra, 410506, India

Location

Shree Samarth Hospital

Pune, Maharashtra, 411028, India

Location

Shivam Hospital

Thane, Maharashtra, 421201, India

Location

Central Study Contacts

Dr. Sanjay Vaze, MBBS

CONTACT

8655670964; sanjay.v@vediclifesciences.com

Dr Shubhangi Mote, BAMS

CONTACT

8655448527; shubhangi.m@vediclifesciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, two-arm, placebo-controlled clinical study

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: October 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 30, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3)