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Fighting Fatty Liver in India

NCT03844165 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-02-18

No results posted yet for this study

Summary

This study aims to build capacity in India by:

1. Developing tailored protocol methodologies for research including technical capability in imaging (MRI/S protocols \& customised software), dietary intervention delivery, dietary evaluation, and biochemical analyses, using available local resources in Kerala.
2. Training and enhancing imaging skills of clinical radiographers in Kerala for research studies
3. Training local professionals and researchers in skills necessary to design, deploy and evaluate diet/lifestyle interventions, including patient engagement, in Kerala.

This study will deliver and evaluate a simple dietary intervention pilot study in the Kerala region in conjunction with local nutritionists, healthcare professionals and partner researchers at PHRI (Population Health and Research Institute, Trivandrum, Kerala, India).

Conditions

  • NAFLD

Interventions

BEHAVIORAL

Diet change (red rice)

This interventions specifically aims to reduce liver inflammation, by replacing white rice in the diet with equal amounts of red rice and lentils. This will also enable for the research team to tests specific scientific hypotheses regarding the effects of diet on insulin resistance, liver pathology and the gut microbiome in NAFLD.

BEHAVIORAL

Yoga

All 84 study participants take part in the yoga intervention. This is an intensive programme organized and delivered by experienced practitioners under direction of Dr Leena Mohan at the Holistic Health and Research Institute. This will evaluate whether physical activity alone improves metabolic health of the liver.

Sponsors & Collaborators

  • Population Health and Research Institute, Trivandrum, Kerala, india

    collaborator UNKNOWN

  • Holistic Health and Research Institute, Trivandrum, Kerala, India

    collaborator UNKNOWN

  • University of Nottingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03844165 on ClinicalTrials.gov