MedPath

Gut and Healthy Ageing

Not Applicable
Completed
Registration Number
CTRI/2023/07/055467
Lead Sponsor
Iom Bioworks Private Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
44
Inclusion Criteria

Participant age between 40-80years.

Participant BMI is between 18 to 29.9 kg/m2.

Participant is self-reported healthy.

Participant include male and female of equal ratio.

Participant is willing to undergo lab investigations and provide stool sample for analysis at suggested timelines.

Participant is willing to follow the suggestions made by the investigators for a duration of 4 weeks.

Participants willing to come to study site in physical twice during the study.

Participants should inform the investigators about any changes undertaken during the period of the study that deviates from inclusion and exclusion criteria.

Exclusion Criteria

Participant is on any strict diet like keto/fad/ vegan/ intermittent fasting etc.

If the participant has used antibiotics, antifungals, anti-viral medication in the last 6 months.

Participant on Antitubercular medications in the last 2 years.

Participant on chemotherapy or received chemotherapy during the past 3 years.

Participant having history of chronic, clinically significant with ongoing medication for systematic illness pertaining to GIT, liver, cardiovascular, hepatic , Pulmonary, renal ailments, and cancer as determined by medical history or physical examination.

Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection.

If the participant has taken large doses of commercially available probiotics for a long duration in the last 6 months. (in any form like tablet, powders, in which probiotics are primary component). Common dietary supplements like yogurt, buttermilk and other preparations made of them are not considered in this.

Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.

If the participant has undergone treatment like induced vomiting (vamana), Induced emesis (Virechana) Medicated enema, procedures like douti, in the past 2 months.

If the participant is on any long-term medications for chronic gut disease from AYUSH system (herb/ home remedies and herbal formulations for improving digestion and amapachana for short term are not considered in this).

If the participant is on any kind of laxatives regularly in the past 6 months.

Participant had covid -19 in the last 2 months

Participant having uncontrolled diabetes (RBS > 200mg/dl and HbA1c >8%).

Participant is having Hypertension Stage II or higher (Systolic >140mmof Hg and Diastolic >90).

If the participant has undergone major surgery of GI tract with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.

If the participant is hyperlipidaemia high risk group.

Pregnant / lactating women.

If the participant is alcoholic/ heavy drinker.

If the participant is a chronic smoker.

If the participant was diagnosed and treated for major psychiatric disorders in the last one year.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Biomarkers and microbial signatures for health that can be used to assess and guide the health of elderly <br/ ><br>Timepoint: baseline and 4th week
Secondary Outcome Measures
NameTimeMethod
Evaluation of microbiome patterns against the hallmarks of ageingTimepoint: Day 1 & at the end of the study after 4 weeks (day 30) following that.
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