MedPath

Role of Oral Activated Charcoal in reducing Blood cholesterol levels

Phase 2
Not yet recruiting
Conditions
Patients whose Total cholesterol level is 200-300mg/dl.
Registration Number
CTRI/2018/08/015298
Lead Sponsor
Gauri Shivaji Bhoite
Brief Summary

Hyperlipidemia can be caused by life style changes and dietary habits. According to NIN and ICMR INDIA B data, the prevalence of Hyperlipidemia is high in India. . So, the burden of hyperlipidemia related diseases in India is alarmingly high and is a serious concern. Indians are not only at high risk of developing cardiovascular diseases, they usually get the disease at an early age, have a more severe form of the disease and have poorer outcome as compared to the western populations. The treatment of diseases secondary to dyslipidemia remains costly. For all these reasons, prevention should take priority.

As the previous researches were done only on Direct Oral Activated charcoal consumption, so now in this research study a Food product is made which is incorporated with Oral Activated Charcoal with the proportions of 5 grams and 10 grams. According to the Asia Pacific Journal of Multidisciplinary Research it was said that Activated charcoal can be incorporated in the food product as an additive for beneficiary effects .To lower the blood lipids,triglycerides and cholesterol Oral activated charcoal has found to be effective.

1.Preparation and formulating the product with oral activated charcoal.

2 .Standardization and sensory evaluation of Incorporated product with oral activated charcoal .The product that has higher acceptability based on sensory evaluation would be supplemented for experimental group.

3.Participants would be divided into two groups - Experimental Group - which would be supplemented with oral activated charcoal incorporated product and Control Group - which would be prescribed Diet and Lifestyle modification for the period of two and a half months.

4.Data collection would be done using direct personal interview method from a structured questionaire containing socio demographic details.

5.Anthropometric measurements used to evaluate the participants present nutritional status are - Weight ,Height ,MUAC,Body fat composition.

6.The biochemical parameters that would be assessed alipid profile.

7.For Experimental Group - Supplementation of Oral activated charcoal incorporated product from 0-4 weeks , 4-8 weeks and 8-10 weeks withdrawal period.

8.For Control Group - They would be prescribed Diet and Lifestyle modification from 0-8 weeks and 8-10 weeks withdrawal period.

9.In both the groups we would be provided with a questionaire containing various symptoms and they have to score each symptom on the basis of its presence.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

INCLUSION: Patients whose Total cholesterol level is 200-300mg/dl would be recruited between the age group of 35 to 65 years including both males and females who are willing to participate.

Exclusion Criteria
  • EXCLUSION: Age group below 35 years.
  • 65 years above,Pregnant and lactating women and with any other comorbid conditions.Patients that are immuno compromised suffering from terminal illness like HIV, Cancer or those who are under medical treatment.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate the effectiveness of accepted activated charcoal product on lipid profile.3 times (Pre intervention,end of 4 weeks and 8 weeks)
Secondary Outcome Measures
NameTimeMethod
• To evaluate the effectiveness of accepted Activated Charcoal product on lipid profile and anthropometric measurements - Height, weight, Hip Circumference, Waist circumference, waist to hip ratio, MUAC, Skin fold thickness (3 sights - chest, abdomen, thigh for men and triceps, suprailliac, thigh for women) of Hyperlipidemic individuals.
To study the variation in the lipid profile and anthropometric measurements during the 2 weeks wash out period.Only once and at end of 10 weeks of study period.

Trial Locations

Locations (1)

Welcomgroup Graduate School of Hotel Administration

🇮🇳

Udupi, KARNATAKA, India

Welcomgroup Graduate School of Hotel Administration
🇮🇳Udupi, KARNATAKA, India
Gauri Shivaji Bhoite
Principal investigator
9108446949
nutritionistgauri@gmail.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.