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NCT04383951 · ClinicalTrials.gov registry record · NA

Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis

A NA study of Cirrhosis, Liver and NASH - Nonalcoholic Steatohepatitis, sponsored by Indiana University.

Active
Registry status
NA
Development phase
40
Enrollment target
1
Study location

NCT04383951 is a NA study of Cirrhosis, Liver and NASH - Nonalcoholic Steatohepatitis that is active but no longer recruiting, run by Indiana University. The registered enrollment target is 40 participants, below the 241-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04383951, a NA study of Cirrhosis, Liver and NASH - Nonalcoholic Steatohepatitis, is active but no longer recruiting, sponsored by Indiana University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

This is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks. Subjects enrolled in the standard of care group will receive a voucher to Weight Watchers after study completion.

Interventions

  • OTHER Dietary consult for participants in the ketogenic diet arm
  • OTHER Dietary consult for participants in the standard of care arm

Study Locations (1)

Indiana

  • Indiana University School of Medicine - Indianapolis

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2020-08-15
Est. Completion 2026-12-31
Phase NA

Sponsor

Indiana University

890 total trials

What the Registry Record Tells You About NCT04383951

The ClinicalTrials.gov registry entry for NCT04383951 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 241-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (83% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 2 interventions - of which Dietary consult for participants in the ketogenic diet arm is the first listed.

NCT04383951 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT04383951 about?

NCT04383951 is a clinical study titled "Safety and Efficacy of Ketogenic Diet for Promoting Weight Loss in Obese Individuals With Compensated NASH Cirrhosis". This is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks. Subjects enrolled in the standard of care group will receive a voucher to Weight Watchers after study complet...

What is the current status of trial NCT04383951?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2020-08-15. Estimated completion is 2026-12-31.

What conditions does trial NCT04383951 study?

This clinical trial studies the following conditions: Cirrhosis, Liver, NASH - Nonalcoholic Steatohepatitis.

What interventions are being tested in trial NCT04383951?

The interventions under investigation include: Dietary consult for participants in the ketogenic diet arm (OTHER), Dietary consult for participants in the standard of care arm (OTHER).

Who is sponsoring clinical trial NCT04383951?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04383951 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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