Clinical trial NCT06658717: A Study to Assess the Effect of the Natural Orange Extract in Individuals With Gastrointestinal Discomfort
Official title: A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to Assess the Effect of the Natural Orange Extract in Individuals With Gastrointestinal Discomfort
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gut Health
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, two-arm, placebo-controlled clinical study
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

1. Individuals willing to give written informed consent form voluntarily to participate in the study
2. Healthy males and females of age between 18-65 years.
3. Individuals with a Body Mass Index (BMI) between 18.5-29.9 kg/m2 (both values included).
4. 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.
5. Individuals with complaints of loose or watery stools, occurring in more than 25% of stools for the last 3 months.
6. Individuals with consistent and stable body weight in the last 3 months prior to screening (less than 5% self-reported change).
7. 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).
8. Individuals with Fasting Blood Glucose (FBG) less than equal to 125 mg/dl.
9. Individuals with systolic blood pressure (SBP) less than 140 and/or diastolic blood pressure (DBP) less than 90 mm Hg.
10. Individuals willing to avoid consumption of citrus-based products during the entire study duration.
11. Individuals willing to follow all the study procedures and follow-up visits as per protocol.

Exclusion Criteria:

1. Individuals diagnosed with diabetes mellitus and are on active medication.
2. Individuals diagnosed with hypertension and are on active medication.
3. 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.
4. 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).
5. Individuals with a history of autoimmune disorders.
6. 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).
7. Any other relevant serious organ or systemic diseases (e.g., cardiovascular, respiratory, liver, renal, neurological disease, etc).
8. Individuals with a history of malignancy within last five years.
9. Use of immunosuppressive drugs within 3 months prior to the screening.
10. Use of oral corticosteroids within 1 month prior to the screening.
11. 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.
12. Individuals with a history of/known allergies to citrus fruits or citrus-based products.
13. Individuals taking any antibiotics in the past 4 weeks and during the study.
14. Individuals who are on regular intake of laxatives in the past 1 month prior to the screening.
15. Individuals taking any dietary supplements, and medication for any gastrointestinal or metabolic disease (peptic ulcer, IBS, type-II diabetes, atherosclerosis, etc.)
16. Individuals taking any hormones for any gastrointestinal or metabolic disease within 3 months prior to screening.
17. Individuals taking any probiotics, prebiotics, post-biotics or synbiotics within 3 months prior to the screening.
18. History of smoking or currently smoking.
19. Individuals with gluten and/or lactose intolerance.
20. Females who are pregnant/lactating or planning to be pregnant.
21. 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.
22. Any other conditions, which in the opinion of the investigator may jeopardize the study.

Primary outcomes:
measure: 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.
timeFrame: Day 0, Day 45, Day 90.
Secondary outcomes:
measure: To assess the effect of IP on the following compared to baseline and placebo Gastrointestinal quality of Life as assessed by GIQLI
timeFrame: Day 0, Day 45, Day 90
measure: 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)
timeFrame: Day 0, Day 45, Day 90
measure: 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
timeFrame: Day 0, Day 45, Day 90
measure: 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)
timeFrame: Day 0, Day 45, Day 90
measure: 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)
timeFrame: Day 0 & Day 90
measure: To assess the effect of IP on the compared to baseline and placebo on Inflammation as assessed by Interleukin-6 (IL-6), Interleukin-10 (IL-10) and Tumor Necrosis Factor-alpha (TNF-α)
timeFrame: Day 0 & Day 90
measure: To assess the effect of IP on the compared to baseline and placebo on Intestinal inflammation as assessed by fecal calprotectin.
timeFrame: Day 0 & Day 90
measure: To assess the effect of IP on the compared to baseline and placebo on Microbial metabolic activity as assessed by fecal short-chain fatty acids (SCFA) [Acetate, Butyrate and Propionate]
timeFrame: Day 0 & Day 90
measure: To assess the effect of IP on the compared to baseline and placebo on The gut microbiome as assessed by Next Generation Sequencing (NGS)
timeFrame: Day 0 & Day 90
Other outcomes:
Locations:
city: Pune
country: India
facility: Pawna Hospital
state: Maharashtra
city: Pune
country: India
facility: Shree Samarth Hospital
state: Maharashtra
city: Thane
country: India
facility: Shivam Hospital
state: Maharashtra
Study officials:
References: