NCT05952232

Brief Summary

The present study is a randomized, placebo-controlled, double-blind, parallel group study to assess the gut health effects of IP as compared to a placebo in overweight individuals experiencing gut issues. Approximately 20 participants aged between 18 and 65 years will be screened for each group. All the five arms of the IP and placebo trial arms will each have at least 10 completed participants after accounting for the screening failure and dropout/withdrawal rate of 20% each. The treatment duration for all the study participants will be 29 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

August 17, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2024

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

June 22, 2023

Last Update Submit

June 14, 2024

Conditions

Gut Health

Outcome Measures

Primary Outcomes (8)

  • To assess efficacy of the natural ingredients on gut permeability as assessed by the change in

    Gut permeability as assessed by the urinary lactulose-mannitol ratio from baseline

    Day 29

  • To assess efficacy of the natural ingredients on gut permeability as assessed by the change in

    Gut protection as assessed by the Aspirin challenge test from baseline

    Day 29

  • To assess efficacy of the natural ingredients on gut permeability as assessed by the change in

    Stool consistency as assessed by Bristol Stool Type from baseline

    Day 29

  • To assess efficacy of the natural ingredients on gut permeability as assessed by the change in

    Gut microbiome as assessed by the fecal pH from baseline

    Day 29

  • To assess efficacy of the natural ingredients on gut permeability as assessed by the change in

    Quality of life as assessed by gastrointestinal quality of life index (GIQLI) from baseline

    Day 29

  • To assess efficacy of the natural ingredients on gut permeability as assessed by the change in

    The stress level as assessed by change in the Perceived Stress Scale (PSS) from baseline

    Day 29

  • To assess efficacy of the natural ingredients on gut permeability as assessed by the change in

    Appetite regulation as assessed by a Three-Factor Eating Questionnaire-R18 (TFEQ-R18) from baseline

    Day 29

  • To assess efficacy of the natural ingredients on gut permeability as assessed by the change in

    Motivation to exercise as assessed by VAS score from baseline

    Day 29

Study Arms (4)

PA-GH-01

ACTIVE COMPARATOR

1 capsule after breakfast once a day

Dietary Supplement: PA-GH-01

MK-GH-04

ACTIVE COMPARATOR

1 capsule after breakfast once a day

Dietary Supplement: MK-GH-04

TSH-GH-03

ACTIVE COMPARATOR

1 capsule after breakfast once a day

Dietary Supplement: TSH-GH-03

PA-GH-02

PLACEBO COMPARATOR

1 capsule after breakfast once a day

Dietary Supplement: PA-GH-02

Interventions

PA-GH-01DIETARY_SUPPLEMENT

1 capsule after breakfast once a day

PA-GH-01
MK-GH-04DIETARY_SUPPLEMENT

1 capsule after breakfast once a day

MK-GH-04
TSH-GH-03DIETARY_SUPPLEMENT

1 capsule after breakfast once a day

TSH-GH-03
PA-GH-02DIETARY_SUPPLEMENT

1 capsule after breakfast once a day

PA-GH-02

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female individuals with the age ≥18 and ≤65 years with moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ-SF)
  • Body mass index \> 18 and \< 29.9 kg/m2
  • Individuals with at least once/ week complains of ≥ 3 of following gastrointestinal symptoms since last three months: dyspepsia, diarrhea, constipation, heartburn, nausea, acid reflux, bloating.
  • Individuals agreeing to consume four tablets (325 mg each) of aspirin twice within a 12-hour period
  • Individuals with fasting blood glucose levels ≤ 125 mg/dL
  • Individuals with availability of western toilet at their homes for stool sample collection
  • Individuals who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.
  • Individuals who are able to give written informed consent and are willing to participate in the study.

You may not qualify if:

  • Individuals diagnosed with IBS including IBS-Constipation, IBS-Mixed, IBS-Diarrhea or Unclassified
  • Allergy to aspirin
  • Use of medications in the last 2 weeks prior to the pre-baseline period. This does not include birth control pills or standard multi-vitamin/mineral supplements
  • Performing high intensity exercise regularly using IPAQ- SF
  • Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening
  • Unwillingness to avoid the use of antidiarrheal or laxative medication on a regular or an "as-needed basis" during the full length of the study
  • Abnormal Thyroid Stimulating Hormone (TSH) value which is \< 0.40 or \> 4.50 μIU/mL
  • Individuals with uncontrolled type II DM defined as FBG \> 125 mg/ dL
  • Presence of uncontrolled hypertension defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg with or without anti-hypertensives
  • Individuals on high-fiber/ fodmap diet
  • Individuals with known diagnosis of helicobacter pylori infection
  • Individuals with a history of surgical resection of the stomach, small intestine or large intestine
  • Individuals with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis
  • Current smokers
  • Use of another investigational product within 3 months of the screening visit
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr. Kumta Mali's Clinic

Mumbai, Maharashtra, 400053, India

Location

Dr. Preeti Bawaskar's Clinic

Thane, Maharashtra, 400607, India

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, Placebo-controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 19, 2023

Study Start

August 17, 2023

Primary Completion

May 27, 2024

Study Completion

May 27, 2024

Last Updated

June 17, 2024

Record last verified: 2024-06

Locations

IN(2)