Effect of supplementing prebiotic Fructooligosaccharide on appetite hormones and obesity outcomes

Acceptability of Fructooligosaccharide (FOS) incorporated Food Items, Effect of Supplementing FOS on Gut Microflora and on Direct/Indirect Determinants of Obese Adults of Urban Vadodara

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012514

Enrollment

300

Registered

2018-03-12

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 (FOS): Oral administration of FOS 20g per day for 90 days (3 months) in two diveded dose of 10g twice a day half hour before Lunch and Dinner meal times. [FOS-P po

provided by Meiji Co., Ltd, Tokyo, Japan] Control Intervention1: Maltrodextrin: Oral administration of Equicaloric Maltodextrin 10g per day for 90 days (3 months) in two diveded dose of 5g twice a day

Eligibility

Inclusion criteria

Inclusion criteria: Non â?? Obese : BMI between 18.5 â?? 22.9 kg/m2 Obese : BMI between 25-30kg/m2 with moderate risk of co-morbidities Middle income group Private bank employees

Exclusion criteria

Exclusion criteria: Subjects diagnosed with following disorders: Hypertension, Diabetes mellitus, Cardiovascular Disorder, Thyroid Hormone Disorder, Valve Replacement Surgery, Gastric surgery or Perforation, Renal Disorder, Locomotor Disorder, Cancer / AIDS, Psychological disorder, Heavy Physical Activity

Design outcomes

Primary

Measure	Time frame
Weight Reduction in kg.Timepoint: Zero day - Pre, 1st month, 2nd month and 3rd month - Post	—

Secondary

Measure	Time frame
24 hour Dietary Recall for 3 consecutive days for Macro-nutrient and Fiber IntakeTimepoint: Zero day and 3rd month [Pre and Post];Becks Depression Inventory Scores greater than 10Timepoint: Zero day and 3rd month [Pre and Post];Defecation ProfileTimepoint: Zero day[Pre], 1st month, 2nd month and 3rd month [Post];Gut Hormones : GLP-1, GIP, PYY, Ghrelin, Leptin and InsulinTimepoint: Zero day and 3rd Month [Pre and Post];Gut Microflora: Bifidobacteria,Lactobacillus,Clostridium and BacteroidesTimepoint: Zero day and 3rd Month [Pre and Post];Hunger scores between 1 - 5Timepoint: Zero day [Pre], 1st month, 2nd month and 3rd month [Post];Satiety scores between 6 - 10Timepoint: Zero day [Pre], 1st month, 2nd month and 3rd month [Post]	—

Measure

Time frame

24 hour Dietary Recall for 3 consecutive days for Macro-nutrient and Fiber IntakeTimepoint: Zero day and 3rd month [Pre and Post];Becks Depression Inventory Scores greater than 10Timepoint: Zero day and 3rd month [Pre and Post];Defecation ProfileTimepoint: Zero day[Pre], 1st month, 2nd month and 3rd month [Post];Gut Hormones : GLP-1, GIP, PYY, Ghrelin, Leptin and InsulinTimepoint: Zero day and 3rd Month [Pre and Post];Gut Microflora: Bifidobacteria,Lactobacillus,Clostridium and BacteroidesTimepoint: Zero day and 3rd Month [Pre and Post];Hunger scores between 1 - 5Timepoint: Zero day [Pre], 1st month, 2nd month and 3rd month [Post];Satiety scores between 6 - 10Timepoint: Zero day [Pre], 1st month, 2nd month and 3rd month [Post]

—

Countries

India

Contacts

Public ContactAparna Assudani

The Maharaja Sayajirao University of Baroda

shethmini@gmail.com8780680784

Outcome results