Clinical trial on overweight adult healthy volunteers

A randomized, double blind, parallel assignment, placebo-controlled, two arm study to evaluate the safety and efficacy of iPulse (multi fruit blend juice) in overweight adult healthy volunteers

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031066

Enrollment

Registered

2021-02-08

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: E663- Overweight

Interventions

Intervention1: i-Pulse (rich multi fruit blend juice): Day 0 to Day 60 Route of administration: orally Dosage form: liquid Duration : 90 days Dose:30 ml Frequency: twice daily Before break fast and

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age/sex: men and women (1:1, equal distribution) aged 18-55 years (Preferably subgroup of age 18-35 and age 36-55, if feasible) 2) Subject with BMI 25-30 kg/m2 3) Subjects who perceive themselves to be under stress and having a score of 14-24 on the Perceived Stress Scale (PSS). 4) Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the investigator 5) Subject willing to provide written informed consent and comes for regular follow up. 6) Subjects who agree to stop from using supplements during the study 7) Subjects willing to follow the suggested diet plan

Exclusion criteria

Exclusion criteria: 1) Female subjects who are pregnant, lactating or planning to become pregnant during the study period. 2) Known history of any chronic illness taking regular pharmacological agents. 3) Significant Gastrointestinal (i.e. inflammatory bowel disease, celiac), liver or kidney disease 4) Cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure) 5) History of major cardiovascular events in the last 1 year (stroke or myocardial infraction) 6) History of drug dependence or any severe co-morbid medical conditions. 7) High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc., Nicotine/Caffeine dependence. 8) Administration of any other multivitamins/herbal product/wellness products 9) Subject has participated in a clinical study within the last 30 days prior to entering this study.

Design outcomes

Primary

Measure	Time frame
1. Primary Measurement will be the safety and tolerability of iPulse through Laboratory ParametersTimepoint: Baseline, 4 weeks and 8 weeks	—

Secondary

Measure	Time frame
2. Secondary Measurement will be to assess the efficacy of I-Pulse through Demographics (Body weight, BMI, Waist circumference)Timepoint: Day 0,Day 45 and Day 90	—

Countries

India

Contacts

Public ContactDr Balu kolar

Radiant Research services pvt. Ltd.

ashok@radiantresearch.in9880999297

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026