Clinical Study of De-Stress & Happy Gut Powder for Stress and Indigestion in Adults.

Official title

A Randomized, Double-blind, Placebo-controlled, Parallel Arm Clinical Trial of De-Stress and Happy Gut Powder in Relieving Stress and Functional Dyspepsia Symptoms in Adults.

Overview

The current study focuses on clinical validation of efficacy of nutraceutical product in relieving stress and functional dyspepsia symptoms in adults for gut health. The effect of these nutraceuticals not only targets the physical symptoms but also enhances overall well-being. Improved digestive health leads to better nutrient absorption, which is essential for energy levels and immune function. Reduced stress levels contribute to better sleep quality, cognitive function, and emotional stability.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel-arm, clinical trial of De-Stress \& Happy Gut powder in relieving stress and functional dyspepsia symptoms in adults.

In this study, more than 81 participants will be enrolled in a 1:1:1 ratio into three groups: Group A (De-stress \& Happy Gut Powder-U001), Group B (De-stress \& Happy Gut Powder-I001), and Group C (Placebo Powder 001). Each participant will take one sachet daily, 30 minutes before breakfast, for 60 days. The efficacy of the investigational products will be compared between the groups.

Concomitant diseases/medication assessment will be performed on screening. The efficacy of the intervention will be assessed by evaluating changes in the Perceived Stress Scale (PSS) score, Nepean Dyspepsia Index (NDI), changes in serum cortisol levels, changes in the COPE Questionnaire (a. Positive Subscale, b. Denial Subscale) score, assessing gut health using a Gastrointestinal Symptom Rating Scale (GSRS) score will be assessed at screening, day 30, and day 60.

Changes in the State-Trait Anxiety Inventory (STAI) score, changes in the Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance, b. Depression) will be assessed at screening and day 60.

Changes in symptom score on a 7-point Likert scale to grade overall symptoms of dyspepsia (Upper abdominal fullness, Pain, Belching, Bloating, Early satiety, Nausea, Vomiting, Regurgitation, Heartburn, Loss of appetite, cravings for junk food) will be assessed at screening, day 15, 30, and day 60.

Changes in gut microbiota at screening and day 60; and time in seconds for relief from pain and heartburn in 5-10 subjects recommended to be used on a need basis in case of acid reflux flare/heartburn will be assessed at baseline, day 15, 30, and day 60.

Treatment compliance, tolerability of investigational products will be assessed at day 30 and day 60. Safety of the investigational treatment in terms of adverse events (AEs), and serious adverse events (SAEs), will be assessed at baseline, day 15, day 30, and day 60.

Assessment of changes in vital sign parameters will be done from screening to end of the study (Day 60).

Interventions

• Other De-stress & happy gut powder-U001
  Take one sachet daily, 30 minutes before breakfast, for 60 days
• Other De-Stress & Happy Gut powder-I001
  Take one sachet daily, 30 minutes before breakfast, for 60 days
• Other Placebo Powder 001
  Take one sachet daily, 30 minutes before breakfast, for 60 days

Primary outcome measures

• Perceived Stress Scale [Time frame: Screening, day 30 and day 60]
• Short Form of Nepean Dyspepsia Index (SF-NDI) [Time frame: Screening, day 30 and day 60]
• COPE Questionnaire [Time frame: Screening, day 30 and day 60]
• Gastrointestinal Symptom Rating Scale (GSRS) [Time frame: Screening, day 30 and day 60]
• Time required to relief pain for acid reflux flare/heartburn symptoms [Time frame: Screening, day 30 and day 60]
• STAI (State-Trait Anxiety Inventory) [Time frame: Screening and day 60]
• Profile of Mood State (POMS) questionnaire [Time frame: Screening and day 60]
• Change in serum cortisol levels [Time frame: Screening, day 15 and day 60]
• Changes in 7 point Likert scale scores [Time frame: Screening, day 15, 30 and day 60]

Secondary outcome measures (9)

• Safety of participant Assessed using adverse events [Time frame: Screening, baseline, day 15, day 30, day 60]
• Safety of participant Assessed using treatment compliance and tolerability of investigational product [Time frame: Screening, baseline, day 15, day 30, day 60]
• Systolic blood pressure difference from reference measurement (mmHg) [Time frame: Screening, baseline, day 15, day 30, day 60]
• Diastolic blood pressure difference from reference measurement (mmHg) [Time frame: Screening, baseline, day 15, day 30, day 60]
• Pulse rate difference from reference measurement (beats per minute) [Time frame: Screening, baseline, day 15, day 30, day 60]
• Complete blood count [Time frame: Screening and day 60]
• Serum Glutamic Pyruvic Transaminase (SGPT) [Time frame: Screening and day 60]
• Serum glutamic-oxaloacetic transaminase (SGOT) [Time frame: Screening and day 60]
• Creatinine difference from reference measurement (mg/dl) [Time frame: Screening and day 60]

Eligibility criteria

Inclusion criteria

• Male and female participants aged 21-50 years both inclusive
• Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
• Participants willing to participate in clinical trials and who have read understood and signed the informed consent form
• No severe anxiety and depression i.e. Generalized anxiety disorder GAD score less than or equal to 10 and Patients' health questionnaire-9 PHQ-9 score less than or equal to 14
• Diagnosis of functional dyspepsia/non-ulcer dyspepsia by fulfilling Rome-III criteria
• Participant should be suffering with at least 4 or more symptoms mentioned below and with a total symptom score of 20 or more based on a 7-point Likert scale (a) Upper abdominal fullness (b) Upper abdominal pain (c) Belching (d) Bloating (e) Early satiety (f) Nausea (g) Vomiting (h) Regurgitation (i) Heartburn (j) Loss of appetite

Exclusion criteria

• Inability to perform any of the assessments required for endpoint analysis
• Known hypersensitivity to investigational products
• Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years
• Advanced chronic illness that would impair follow-up or monitoring
• Participants who have used dietary supplements, medications, such as oral/IV antibiotics or probiotics, or supplements known to affect hunger, satiety, appetite, or gut microbiome within three months prior to recruitment. Additionally, individuals currently using nutraceuticals, allopathic, or ayurvedic supplements for stress and or gastrointestinal health management;
• Participants suffering from abdominal obesity that is waist circumference of more than 80 cm in females and of more than 90 cm in male;
• Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
• Participants with current or past diagnoses of peptic ulcer disease, gastroesophageal reflux disorder (GERD), or irritable bowel syndrome (IBS), as well as those who have undergone surgery related to these conditions
• Have any other neurodegenerative diseases, mental illness or dementia
• Any other clinical condition in the judgment of investigator finds the study participation unsuitable for the participant.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06568965 · MHC/CT/24-25/015 · CTRI/2024/07/071248

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗