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

Summary

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.

Conditions

• Obesity
• Overweight

Interventions

DIETARY_SUPPLEMENT

Experimental Bar (Formulation 1) + Hypocaloric diet (10% energy restriction)

Participants will consume three satiating compound-enriched bars (formulation 1) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.

DIETARY_SUPPLEMENT

Experimental Bar (Formulation 2) + Hypocaloric diet (10% energy restriction)

Participants will consume three satiating compound-enriched bars (formulation 2) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.

DIETARY_SUPPLEMENT

Experimental Bar (Formulation 3) + Hypocaloric diet (10% energy restriction)

Participants will consume three satiating compound-enriched bars (formulation 3) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.

DIETARY_SUPPLEMENT

Placebo Bar + Hypocaloric diet (10% energy restriction)

Participants will consume three placebo bars daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• María Ángeles Zulet, PhD · Center for Nutrition Research

• Fermín Milagro, PhD · Center for Nutrition Research

• Idoia Ibero · Center for Nutrition Research

• María Hernández · Center for Nutrition Research

• Miguel López, PhD · Center for Nutrition Research

• Verónica Ciaurriz · Center for Nutrition Research

• Carlos J González, PhD · Center for Nutrition Research

• Salomé Pérez · Center for Nutrition Research

• Marián Pueyo · Center for Nutrition Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-08-20

Primary Completion

2026-05-30

Completion

2026-06-30

Countries

• Spain

Study Locations