A clinical saftey and efficacy trial of Sugarlite a marketeted product on Healthy lifestyle modification

â??An Open label , two arms active controlled and randomized , Clinical Study to Evaluate the Efficacy and Safety of Sugarlite, A Unique Sugar Blended Formulation in Normal to Mild overweight subjects.â??

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/02/030921

Enrollment

Registered

2021-02-02

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: Sugar substitute: this is a study where an sugar substitute is compared with normal sugar in a comaprative study on body weight , waist and hip circumference and metabolic parameters li

Eligibility

Inclusion criteria

Inclusion criteria: •Subjects of both sexes in the age group of 18 - 45 years •Normal to Pre obese subjects (BMI â?? 23.00kg/M2 to 26 kg/M2) •Subjects willing to give written informed consent. •Those who agree to follow the general guidelines on diet, sugar intake and exercise. •Subjects who have not participated in similar kind of study in last 4 weeks.

Exclusion criteria

Exclusion criteria: • Subjects with established hypertension, renal, hepatic or cardiac failure • Endocrine disorders like Hypothyroid ( if already on treatment) • Subjects with Dyslipidemia or Inborn errors of Fat metabolism. • Subjects with Postprandial sugars above 150 mg /dl in two tests so can be labelled Early Diabetic • History of drug hyper sensitivity or allergic condition that might interfere with the study • Use of drugs or dietary supplements that might influence body weight, body fat, or serum lipid levels like Anti diabetic drugs like Metformin and Statins. • Pregnant & lactating women. • Not willing to sign informed consent form.

Design outcomes

Primary

Measure	Time frame
Weight , BMI , Blood glucose and Lipid ParametersTimepoint: Baseline , 30 days , 60 days and 90 days	—

Secondary

Measure	Time frame
Blood cholesterol , Trigycerides, random bllod sugar and Hba1 C valuesTimepoint: Once every month for 3 months after baseline values	—

Countries

India

Contacts

Public ContactDr Sunil Kumar Prabhu

Sarani Biointgra private limited

sunilpr13@gmail.com9945825226

Outcome results