A clinical study of a functional food product in Regulating Blood Glucose in Pre-diabetic Subjects

Completed

• Conditions: Pre-diabetes

• Registration Number: CTRI/2018/02/012035
• Lead Sponsor: ITC Life Sciences and Technology Center

Brief Summary

This study was a randomized, double blind, parallel group trial for evaluating the safety and efficacy of test/placebo biscuits in pre-diabetic subjects. Total 150 subjects were  enrolled from single center (India) to get at least 129 evaluable subjects.

To access outcome  maintenance and /or mean change in fasting blood glucose from baseline to end of treatment i.e week 12 and  safety of biscuits in pre-diabetic subjects maintenance and /or mean change in parameters like  HbA1c, HDL, VLDL, TG, BP, Fructosamine level.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-09
• Study Completion: 2017-05-09
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Males and females greater than or equal to 18 and less than or equal to 65 years of age 2.
• Body mass index of greater than or equal to 18.5 and less than or equal to 30 kg per m2 3.
• Pre-diabetic subjects with fasting blood glucose between 100 and 125 mg/dL (called impaired fasting glucose or IFG), IGT (greater than or equal to 140 and less than 200), and HbA1c levels greater than or equal to 5.7% and less than or equal to 6.4% 4.
• Subjects willing to comply with diet control 5.
• Subjects with history of stable weight, defined as no significant weight change (less than ±5%) within three months prior to enrollment 6.
• If on anti-hypertensive therapy, the dosage must be constant for at least 2 months prior to the screening visit, based on medical history.
• Females of child-bearing potential and males should be willing to use adequate methods of contraception.
• Must be willing to give written informed consent and comply with the study procedures.

Exclusion Criteria

• Type 1 or type 2 diabetes mellitus 2.
• Subject with lipid abnormalities or thyroid disorders 3.
• Pregnant or lactating women 4.
• Subjects requiring a fibre free diet 5.
• Subject requiring enteral tube feed or parenteral nutrition 6.
• Diagnosed with an eating disorder such as bulimia or binge eating 7.
• Any acute gastrointestinal disease within 2 weeks prior to study entry 8.
• History of Cancer 9.
• Clinically significant cardiac disease or endocrine abnormalities 10.
• Untreated major psychiatric disorder 12.
• History of bariatric surgery 13.
• Known HIV positive 14.
• Serum creatinine of greater than or equal to 1.5 mg per dL 15.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values greater than or equal to 2.5 X Upper Limit of Normal (ULN).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effects assessed in terms of maintenance and/or mean change in blood glucose (FBG, PPBG) from baseline to end of treatment i.e. 12 weeks, between the two test biscuit groups and compare to placebo group	At week 12

Secondary Outcome Measures

Name	Time	Method
Maintenance and /or mean change in	HbA1c, QUICKI, body weight, waist circumference, BMI, lipid parameters (HDL, LDL, VLDL and TG),

Trial Locations

Locations (1)

Karmic Lifesciences LLP; 🇮🇳 Ahmadabad, GUJARAT, India

Karmic Lifesciences LLP

🇮🇳Ahmadabad, GUJARAT, India

Dr Vipul Doshi

Principal investigator

07966219521

vipul.doshi@karmiclifesciences.com