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NCT05896358: WRKD

Dietary Treatment for Post Bariatric Weight Regain

Status unknown Last updated 18 June 2023
What this trial tests

trial testing ketogenic diet in Obesity in 30 participants. Status unknown.

Timeline
1 March 2023
Primary endpoint
30 June 2023
30 January 2024

Quick facts

Lead sponsorUniversity of Roma La Sapienza
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment30
Start date1 March 2023
Primary completion30 June 2023
Estimated completion30 January 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Roma La Sapienza

Who can join

18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Metabolic surgery has, among all obesity treatments, the best long term efficacy, but weight regain (weight regain, WR) or insufficient weight loss (IWL) are relatively common. These are hard to treat, with dietary treatment often failing, and redo surgery being commonly proposed.The ketogenic diet is vastly utilised to obtain weight loss in obesity, but little data is available regarding its application on post bariatric patients. Ad hoc designed studies are needed to confirm the efficacy and safety of a VLCKD in the treatment of WR and IWL. The aim of this study is to test whether the ketogenic diet is a safe and effective treatment in post bariatric weight regain, compared to its application before bariatric surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Impact of a very low-calorie ketogenic diet on metabolic and microbiota outcomes in post-bariatric patients and bariatric-Naïve individuals: A comparative pilot study.
    Ernesti I, Massari MC, Cipriani F, Masi D, et al · · 2025 · cited 5× · PMID 39791264 · DOI 10.1111/dom.16187

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Other trials of ketogenic diet

Trials testing the same drug.

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Other University of Roma La Sapienza trials

Trials by the same sponsor.

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