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Study Arms (2)

Diet change (red rice) with yoga

EXPERIMENTAL

Following randomisation, participants are given a schedule of group and personal meetings and details of each session. Food for the diet (red rice and lentils) will be provided for those randomised to the diet arm. The study will last 16 weeks following start of the diet/yoga programme. There will be further visits to measure outcomes at week 8 and week 16. All participants in both arms will complete the same programme of Yoga sessions, organized and delivered by experienced practitioners under direction of Dr Leena Mohan at the Holistic Health and Research Institute.

Behavioral: Diet change (red rice)Behavioral: Yoga

Yoga

ACTIVE COMPARATOR

Following randomisation, participants are given a schedule of group and personal meetings and details of each session. The study will last 16 weeks following start of the diet/yoga programme. There will be further visits to measure outcomes at week 8 and week 16. All participants in both arms will complete the same programme of Yoga sessions, organized and delivered by experienced practitioners under direction of Dr Leena Mohan at the Holistic Health and Research Institute.

Interventions

Diet change (red rice)Behavioral

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.

Diet change (red rice) with yoga

YogaBehavioral

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.

Eligibility Criteria

Age18 Years+

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsA number of gender specific confounders (menstrual cycle, age etc) mean that mechanistic studies in small sample sizes are limited to men. The local cohort being used comprises males only.

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

aged 18 years or over

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Yoga

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

INVESTIGATOR

Masking Details

The participant and study team will not be blinded to this allocation, although the scientist and radiology team will be blinded when analysing samples/scans.

Purpose

OTHER

Intervention Model

PARALLEL

Model Details: This is two-arm dietary interventional study that will be conducted through the Population Health and Research Institute, Trivandrum, India. Participants will be randomised to one of two study arms: diet change with yoga or yoga. We will aim to recruit 42 participants to each arm.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Fighting Fatty Liver in India

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Diet change (red rice) with yoga

Yoga

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Diet change (red rice) with yoga

Yoga

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations