NCT06680635

Effect of Citrus Flavonoids on Obesity.

Completed NA Last updated 27 February 2025

What this trial tests

NA trial testing Flavonoid-enriched juice and a low-calorie diet in Obesity Adult Onset in 80 participants. Completed in 31 January 2025.

Timeline

1 January 2022

Primary endpoint
31 December 2024

31 January 2025

Quick facts

Lead sponsor	Celia Bañuls
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	1 January 2022
Primary completion	31 December 2024
Estimated completion	31 January 2025
Sites	1 location across Spain

Drugs / interventions tested

• Flavonoid-enriched juice and a low-calorie diet
• Food supplement: placebo juice and a low calorie diet

Conditions studied

• Obesity Adult Onset — all drugs for Obesity Adult Onset →
• Diabetes Mellitus Type 2 — all drugs for Diabetes Mellitus Type 2 →

Sponsor

Celia Bañuls — full company profile →

Who can join

Adults 18 to 65, any sex, with Obesity Adult Onset or Diabetes Mellitus Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to evaluate whether the intake of a functional juice enriched in citrus polymethoxylated flavonoids is able to improve the glycaemic profile and insulin resistance of obese patients by reversing the associated oxidative and inflammatory stress, as well as the differential alteration of the intestinal microbiota. To achieve this, a prospective, randomised, double-blind, placebo- controlled, clinical-baseline intervention study will be conducted in obese patients (BMI=30-40 kg/m2) with type 2 diabetes (DM2) (n=40) and obese patients without alterations in carbohydrate metabolism (n=40). Each of these groups will be randomly divided into 2 subgroups (n=20), one of which will receive polymethoxyflavonoid-enriched orange juice (14%: nobiletin, sinensetin, tangeretin) (200 ml/ day) and the other group will receive the corresponding placebo juice for 8 weeks. In addition, all of them will receive a hypocaloric diet. Anthropometric parameters, body composition and nutritional status will be assessed, cardiovascular risk factors and comorbidities will be studied (HT, SAHS, dyslipidaemia, insulin resistance), oxidative stress parameters will be compared (total and mitochondrial ROS production, mitochondrial membrane potential, glutathione levels by static cytometry and mitochondrial respiration rate by Seahorse flow analyser), antioxidant enzymes (SOD, GPx) and molecular oxidation products (Carbonyl proteins and 8-oxo-dG, LDLox) and LPS by ELISA techniques, inflammatory parameters (IL6, TNFa, IL1b, adiponectin, PAI-1, IL10) by Luminex XMAP technology in serum. Metabolomic analysis will also be performed in plasma (NMR spectroscopy and PLS-DA), and the content and diversity of the gut microbiota (16S rRNA amplicons, and direct metagenomic sequencing, with Illumina MiSeq technology) will be assessed in faeces, before and after the dietary intervention. Individualised dietary follow-up and assessment of subjects' quality of life will be carried out.

Publications & conference data

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

1. 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