NCT07165548: COGLUBOCO

Impact of Satiating Compounds and Hypocaloric Diet on Weight, Cardiometabolic and Osteoarticular Health in Obesity

Recruiting now NA Last updated 10 September 2025

What this trial tests

NA trial testing Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction) in Obesity in 144 participants. Currently enrolling.

Timeline

20 August 2025

Primary endpoint
30 May 2026

30 June 2026

Quick facts

Lead sponsor	Clinica Universidad de Navarra, Universidad de Navarra
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	144
Start date	20 August 2025
Primary completion	30 May 2026
Estimated completion	30 June 2026
Sites	1 location across Spain

Drugs / interventions tested

• Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction)
• Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction)
• Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction)
• Placebo Bar + Hypocaloric diet (10% energy restriction)

Conditions studied

• Obesity — all drugs for Obesity →
• Overweight — all drugs for Overweight →

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Who can join

Adults 18 to 65, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective of this intervention study is to evaluate the effect of satiating protein and/or fiber bar consumption on weight loss and other osteoarticular and cardiometabolic parameters related to excess weight in subjects with overweight or obesity.

To achieve this objective, volunteers will be instructed to consume three bars per day as part of a hypocaloric diet, in accordance with healthy nutritional guidelines, over a 12-week period.

The main questions to answer are:

* Does the regular consumption of these protein and/or fiber bars help to lose weight?
* Does the regular consumption of these protein and/or fiber bars help to improve the osteoarticular health?
* Does the regular consumption of these protein and/or fiber bars help to improve the cardiometabolic health?

The specific objectives are focused on evaluating the effects of the intervention on the following parameters:

* Weight and body composition.
* Knee joint range of motion.
* Blood biomarkers related to collagen degradation and synthesis, associated with osteoarticular health.
* Glycemic and lipid profiles, blood pressure, and biomarkers of kidney, liver, cardiovascular, and inflammatory health.
* Changes in joint discomfort (improvement or worsening).
* Adherence to the assigned intervention, including both dietary compliance and intake of the study-provided supplement.
* Satiety-related variables assessed using a visual analog scale (VAS).
* Urinary hydroxyproline and stool samples for metagenomic analysis.
* Gastrointestinal health, mental health, quality of life, and physical activity level assessed through validated questionnaires.

Target sample size is 144 subjects and participants will be allocated in four different groups:

* Group 1 (n=36): hypocaloric diet + protein and fiber supplement.
* Group 2 (n=36): hypocaloric diet + protein and fiber supplement.
* Group 3 (n=36): hypocaloric diet + fiber supplement.
* Group 4 "Placebo group" (n=36): hypocaloric diet + placebo supplement. Participants will attend the nutritional intervention unit at weeks 1, 8, and 12. A follow-up phone call will be conducted at week 4.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.