Gut HealthNCT06658717
A Study to Assess the Effect of the Natural Orange Extract in Individuals With Gastrointestinal Discomfort
A study testing Investigational product (IP): Natural orange extract in people with Gut Health, run by Vedic Lifesciences Pvt. Ltd. at 3 sites in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Health
- What is being tested?
- Investigational product (IP): Natural orange extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 3 sitesIndia
- Study dates
- 15 Oct 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Show all 11Show fewer
- 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.
Who cannot join
- 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).
Show all 22Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Pawna Hospital
Pune, Maharashtra, 410506
Dr Dhamne Akshay Anant, MBBS MD, 9168469303, drakshay.pawana@gmail.com
Shree Samarth Hospital
Pune, Maharashtra, 411028
Dr. Bharatkumar Dholu, MBBS ;MS, 8805387387, drbkddholu@gmail.com
Shivam Hospital
Thane, Maharashtra, 421201
Dr. Kushal Bangar, MBBS, 9545664884, dr.kushal.bangar83@gmail.com
About this study
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
A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to assess the Effect of the Natural Orange Extract in Individuals with Gastrointestinal Discomfort
Read the 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
- Conditions
- Gut Health
- Being tested
- Investigational product (IP): Natural orange extract, Group II: Placebo: Microcrystalline cellulose (MCC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational product (IP): Natural orange extractDietary supplement
Strength: 500 mg Dose regimen: One capsule to be taken with breakfast orally once a day
Group II: Placebo: Microcrystalline cellulose (MCC)Dietary supplement
Strength: 500 mg Dose regimen: One capsule to be taken with breakfast orally once a day
| Study group | Role | What they receive |
|---|---|---|
| Group I: Investigational product (IP) | Experimental | One capsule to be taken with breakfast orally once a day Receives: 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 Receives: Dietary Supplement: Group II: Placebo: Microcrystalline cellulose (MCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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)
The Bristol Stool Form Scale (BSFS) is a 7-point ordinal scale of stool types extensively used in clinical and research settings that classify feces into seven groups
Measured: 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
The Bristol Stool Form Scale (BSFS) is a 7-point ordinal scale of stool types extensively used in clinical and research settings that classify feces into seven groups
Measured: 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)
The GSRS is a self-reported questionnaire for GI discomfort. The questions in this scale ask about the severity of a wide range of gastrointestinal symptoms of an individual during the past week. Questions are to be rated on a Likert scale ranging from no discomfort at all (0) to very severe discomfort (3). A total score is calculated by summing the ratings provided on all questions
Measured: 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)
LPS is detected throughout the body by a specific protein called Lipopolysaccharide binding protein (LBP). LBP then initiates the immune response by presenting LPS to cell surface pattern recognition receptors membrane-bound CD14 (mCDC14) and toll-like receptor-4 (TLR4).
Measured: Day 0 & Day 90
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)
Inflammation serves as a natural defensive reaction of the innate immune system triggered by various harmful agents such as microorganisms, trauma, necrosis, chemicals, immune responses, or metabolic stress.
The acceptable ranges proposed are as follows: IL-6 (Not detectable to 50 pg/ml), IL-10 (Not detectable to 8 pg/ml), and TNF-α (2 to 20 pg/ml)
Measured: Day 0 & Day 90
To assess the effect of IP on the compared to baseline and placebo on Intestinal inflammation as assessed by fecal calprotectin.
The fecal calprotectin a highly sensitive marker for detecting inflammation associated with GI disorders. The concentration of fecal calprotectin correlates well with the severity of intestinal inflammation,The fecal calprotectin range was found to be 18-37 μg /g in IBS individuals
Measured: Day 0 & Day 90
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]
SCFAs exert beneficial effects on gut health through various mechanisms. They help maintain intestinal barrier integrity, promote mucus production, and possess anti-inflammatory properties, thereby contributing to overall GI well-being.
These SCFAs range from 20 to 140 mM in the gut, with higher concentrations found in the proximal colon (70-140 mM) and lower concentrations in the distal colon (20-70 mM) and distal ileum (20-40 mM).
Measured: Day 0 & Day 90
To assess the effect of IP on the compared to baseline and placebo on The gut microbiome as assessed by Next Generation Sequencing (NGS)
NGS allows for a more comprehensive analysis of complex microbial communities compared to traditional culture-based methods. The declining costs associated with NGS have further propelled its widespread adoption in microbiome research. NGS has proven particularly advantageous in elucidating the intricate relationship between the microbiome and various conditions.NGS will be assessed on day 0 and day 90
Measured: Day 0 & Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, two-arm, placebo-controlled clinical study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658717
- Sponsor's protocol ID
- HT/240501/CARD/GID
- Status last verified
- Sep 2024
- First submitted
- 23 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06658717
- Acronym / sponsor ID
- HT/240501/CARD/GID
- Conditions
- Gut Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, two-arm, placebo-controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Group I: Investigational product (IP) | Experimental | Dietary Supplement: Investigational product (IP): Natural orange extractOne capsule to be taken with breakfast orally once a day |
| Placebo: Microcrystalline cellulose (MCC) | Placebo comparator | Dietary Supplement: Group II: Placebo: Microcrystalline cellulose (MCC)One capsule to be taken with breakfast orally once a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational product (IP): Natural orange extractStrength: 500 mg Dose regimen: One capsule to be taken with breakfast orally once a day | Dietary supplement | Group I: Investigational product (IP) |
| Group II: Placebo: Microcrystalline cellulose (MCC)Strength: 500 mg Dose regimen: One capsule to be taken with breakfast orally once a day | Dietary supplement | Placebo: Microcrystalline cellulose (MCC) |
Primary outcome
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.
Time frame: Day 0, Day 45, Day 90.
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
9 secondary outcomes
To assess the effect of IP on the following compared to baseline and placebo Gastrointestinal quality of Life as assessed by GIQLI
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Day 0 & Day 90
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)
Time frame: Day 0 & Day 90
To assess the effect of IP on the compared to baseline and placebo on Intestinal inflammation as assessed by fecal calprotectin.
Time frame: Day 0 & Day 90
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]
Time frame: Day 0 & Day 90
To assess the effect of IP on the compared to baseline and placebo on The gut microbiome as assessed by Next Generation Sequencing (NGS)
Time frame: Day 0 & Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Gut Health
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Recruiting
Tiny Tummies - A Milk Study
Gut Microbiome, Neurocognitive Correlates of Eating Habits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational product (IP): Natural orange extract in people with Gut Health, run by Vedic Lifesciences Pvt. Ltd. at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Sanjay Vaze, MBBS (8655670964, sanjay.v@vediclifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 0, Day 45, Day 90.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.