A clinical trial to study the effect of supplementing prebiotic Fructooligosaccharide on the direct and indirect determinants of the obesity outcomes in young adults (25 â?? 35 years age).

Sensory evaluation of fructooligosaccharide (FOS) added popular recipes of India and its role in modulating anthropometric indices, atherogenic profile, gut flora and lipopolysaccharide (LPS) in obese young adults of urban Vadodara.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/02/006611

Enrollment

200

Registered

2016-02-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Fructooligosaccharide: 20g/day for 90 days. Mode of Administration-Oral Control Intervention1: Maltodextrin: Maltodextrin, a placebo, Dose 20 gms BD for 3 months Control Intervention2:

Eligibility

Inclusion criteria

Inclusion criteria: Target Population: Obese (Grade-I) young Adults with Moderate risk of Co-morbidities Obesity defined as: >25 â?? 29.9 BMI Age: 25 â?? 35 yrs Gender: Both (Male and Female)

Exclusion criteria

Exclusion criteria: Subjects having confirmed following disorders: Diabetes Mellitus Hypertension Cardio Vascular Disorder Thyroid Hormone Disorder Valve Replacement Surgery Gastric Surgery or perforation Taking Steroid based Medication Immunocompromised Subjects Heavy Physical Activity Undergoing any treatment for Obesity

Design outcomes

Primary

Measure	Time frame
Weight loss Timepoint: Time-points: 0 day, 1months, 2 month and 3 months	—

Secondary

Measure	Time frame
Atherogenic Profile (TC, TG, HDL, LDL and VLDL)Timepoint: 0 day and 3 month;Change in the levels of Plasma Lipopolysaccharide (Endotoxin)Timepoint: 0 day and 3 months;Defecation ProfileTimepoint: Zero day, 1months, 2 month and 3 months;Gut Microflora (Bifidobacteria, Lactobacillus, Clostridium, Bacteroides) Timepoint: 0 day and 3 months;Hunger â?? Satiety ScaleTimepoint: Zero day, 1months, 2 month and 3 months;Reduced Calorie consumption (24 hr Dietary Recall for 3 consecutive days)Timepoint: Zero day, 1months, 2 month and 3 months	—

Measure

Time frame

Atherogenic Profile (TC, TG, HDL, LDL and VLDL)Timepoint: 0 day and 3 month;Change in the levels of Plasma Lipopolysaccharide (Endotoxin)Timepoint: 0 day and 3 months;Defecation ProfileTimepoint: Zero day, 1months, 2 month and 3 months;Gut Microflora (Bifidobacteria, Lactobacillus, Clostridium, Bacteroides) Timepoint: 0 day and 3 months;Hunger â?? Satiety ScaleTimepoint: Zero day, 1months, 2 month and 3 months;Reduced Calorie consumption (24 hr Dietary Recall for 3 consecutive days)Timepoint: Zero day, 1months, 2 month and 3 months

—

Countries

India

Contacts

Public ContactNidhi Jain

The Maharaja Sayajirao University of Baroda

shethmini@gmail.com09879359229

Outcome results