Health Condition 1: E889- Metabolic disorder, unspecified
Conditions
Interventions
Intervention1: Potion1st Fibre Rich Smoothies: Fibre rich freeze dried formulations, prepared by mixing 3-4 freeze dried, everyday, fibre rich fruits and vegetables to ensure diverse fibre subtype in
Sponsors
Proxi Farma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participant Inclusion Criteria (Healthy Volunteers) a. Between 25 to 60 years of age b. Healthy volunteers with no diagnosed chronic disorder. c. Those willing to abide by the requirements and conditions of the study and agreeing to provide written informed consent Participant Inclusion Criteria (Metabolic Syndrome) a. Patients of either sex diagnosed with metabolic syndrome with three or more of the following criteria as per NCEP/ ATP III, and not currently on any medications, as the trial aims to assess the efficacy of dietary intervention alone. i. Abdominal obesity: Having a waist circumference greater than 40 inches for men and 35 inches for women when measured at the umbilical region. ii. Elevated Blood Pressure: Having systolic blood pressure of 130 mm Hg or higher, or diastolic blood pressure of 85 mm Hg or higher. iii. High Blood Glucose Levels: Having fasting plasma glucose levels above 110 mg/dL iv. Triglyceride Levels: Having elevated triglyceride levels of 150 mg/dL or higher. v. Low HDL Cholesterol Levels: Having low HDL cholesterol levels below 40 mg/dL for men and below 50 mg/dL for women. b. Between 25 and 60 years of age c. Those willing to abide by the requirements and conditions of the study and agreeing to provide written informed consent
Exclusion criteria
Exclusion criteria: Participant Exclusion Criteria (for both Healthy and Metabolic Syndrome) Exclusion criteria for participants of either group are the same as follows: 1. Currently on any medication. 2. Known allergies to any food product. 3. Pregnant or lactating women. 4. Individuals with any malignant disorder currently or in the past. 5. Individuals with psychiatric disorders or those with substance abuse. 6. Individuals who have been on antibiotics in the last 3 months. 7. Participants who have been involved in any other clinical trial within the last 6 months. 8. Participants who have undergone major surgery within the last 6 months. 9. Participants who have experienced significant weight changes (more than 5% of body weight) in the past 3 months. 10. Individuals consuming more than 14 units of alcohol per week for women and more than 21 units per week for men.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Part A: Compare the effect of freeze dried fibre rich fibre food on propensity to generate microbiome derived metabolites specifically short chain fatty acids. For Part B: To evaluate the effectiveness of the dietary intervention on gut health by quantifying changes in the Gut Microbiome Health Index (GMHI).Timepoint: 21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemistry to assess metabolic health, estimation of microbiome metabolitesTimepoint: Day 21;To study the correlation between the changes in gut microbiome induced by high fibre foods by ex vivo incubation and following in vivo administration.Timepoint: Day 21 | — |
Countries
India
Contacts
Public ContactDr Madhur Motwani
Proxi Farma Pvt Ltd
Outcome results
None listed