A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to assess the Effect of the Natural Orange Extract in Individuals with Gastrointestinal Discomfort
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 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).
Parallel
Investigational product (IP): Natural orange extract
Dietary supplementStrength: 500 mg Dose regimen: One capsule to be taken with breakfast orally once a day
Group II: Placebo: Microcrystalline cellulose (MCC)
Dietary supplementStrength: 500 mg Dose regimen: One capsule to be taken with breakfast orally once a day
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
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
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
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
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
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