NCT06279780

Gut Microbiota, Mitochondrial Function and Metabolic Health in Obesity

Completed NA Last updated 27 February 2025

What this trial tests

NA trial testing very low-calorie diet in Obesity Adult Onset in 109 participants. Completed in 31 August 2024.

Timeline

1 January 2019

Primary endpoint
31 December 2023

31 August 2024

Quick facts

Lead sponsor	Celia Bañuls
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	109
Start date	1 January 2019
Primary completion	31 December 2023
Estimated completion	31 August 2024
Sites	1 location across Spain

Drugs / interventions tested

• very low-calorie diet

Conditions studied

• Obesity Adult Onset — all drugs for Obesity Adult Onset →

Sponsor

Celia Bañuls — full company profile →

Who can join

Adults 18 to 60, any sex, with Obesity Adult Onset. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It has been suggested that individuals with the condition known as metabolically healthy obesity (MHO) may not have the same increased risk of developing metabolic abnormalities as their non-metabolically healthy counterparts. In addition, to date, the identification of metabolic biomarkers and microbiota underlying the MHO state is limited. In this study, our goal is to provide insight into the underlying metabolic pathways affected by obesity. To achieve this, we will compare the metabolic profile, inflammatory parameters and mitochondrial function, as well as metabolomic analysis and differential expression of microbiota in obese patients categorized as metabolically healthy vs. non healthy. In parallel, the effect of a hypocaloric diet on obese subjects' metabolism and microbiota will be assessed to approve their use in the treatment of said disorder. Specifically, we propose an observational, clinical-basic, comparative and interventional study in a population of 80 obese (BMI\>35 kg/m2) patients clustered in two groups according to the presence or absence of altered metabolism (altered fasting glycemia, hypertension, atherogenic dyslipidemia). Anthropometric and clinical variables and biological samples (serum, plasma, peripheral blood cells and feces) will be collected for the determination of biochemical parameters (glucose, lipid and hormonal profile by enzymatic techniques) and protein-based peripheral biomarkers of mitochondrial function \[total and mitochondrial reactive oxygen species (ROS) production, mitochondrial membrane potential, glutathione levels by static cytometry\], markers of mitochondrial dynamics \[Mitofusin 1 (MFN1), Mitofusin 2 (MFN2), Mitochondrial fision protein 1 (FIS1) and Dynamin-related protein 1 (DRP1) by RT-PCR and Western Blot\], markers of inflammation \[Interleukin 6 (IL6), Tumoral necrosis factor alpha (TNFα), IL1b, adiponectin, resistin, plasminogen activator inhibitor 1 (PAI-1), Monocyte chemoattractant protein-1 (MCP-1), caspase 1 and NLRP3 by Western Blot and technology XMAP), metabolomic assay (NMR spectroscopy and PLS-DA), as well as gut microbiota content and diversity (16S rRNA, MiSeq sequencing). Finally, we will evaluate the effect of a dietary weight loss intervention on these biomarkers.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of a Very Low-Calorie Diet on Oxidative Stress, Inflammatory and Metabolomic Profile in Metabolically Healthy and Unhealthy Obese Subjects.
   Bosch-Sierra N, Grau-Del Valle C, Salom C, Zaragoza-Villena B, et al · · 2024 · cited 15× · PMID 38539836 · DOI 10.3390/antiox13030302
2. The Impact of Weight Loss on Inflammation, Oxidative Stress, and Mitochondrial Function in Subjects with Obesity.
   Bosch-Sierra N, Grau-Del Valle C, Hermenejildo J, Hermo-Argibay A, et al · · 2024 · cited 10× · PMID 39061938 · DOI 10.3390/antiox13070870
3. Potential and Mechanism of Nobiletin in Diabetes Mellitus and Associated Complications.
   Zhao C, Lai W, Li Y, Hong K, et al · · 2025 · cited 2× · PMID 41155643 · DOI 10.3390/ph18101528
4. Weight loss increases circadian gene expression and emotional well-being in individuals with obesity.
   Grau-Del Valle C, Bosch-Sierra N, Hermo-Argibay A, López-Domenech S, et al · · 2025 · PMID 41383341 · DOI 10.3389/fnut.2025.1722428