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

NCT07165548 | Recruiting

• 1 other identifier: COGLUBOCO (2025.116)
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nutritional intervention; Dietary supplement; Protein bar; Fiber bar; Hypocaloric Diet; Obesity; Weight loss; Satiety; Cardiometabolic health; Osteoarticular health; Quality of life

Outcome Measures

Primary Outcomes (1)

• Body weight

  Weight of participants will be measured by bioimpedance an densitometry and reported in kg

  Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3

Secondary Outcomes (66)

• Height

  Clinical Investigation Day 1

• Body mass index

  Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3

• Waist circumference

  Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3

• Hip circumference

  Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3

• Neck circumference

  Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3

Study Arms (4)

Experimental group 1

EXPERIMENTAL

Bars containing satiating compounds: formulation 1

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

Experimental group 2

EXPERIMENTAL

Bars containing satiating compounds: formulation 2

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

Experimental group 3

EXPERIMENTAL

Bars containing satiating compounds: formulation 3

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

Placebo group

PLACEBO COMPARATOR

Placebo bars

Dietary Supplement: Placebo Bar + Hypocaloric diet (10% energy restriction)

Interventions

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

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.

Experimental group 1

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

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.

Experimental group 2

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

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.

Experimental group 3

Placebo Bar + Hypocaloric diet (10% energy restriction) DIETARY_SUPPLEMENT

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers of both sexes between the ages of 18 and 65 years old.
• Volunteers with grade II overweight or obesity (BMI: 27.0-39.9 kg/m2).
• Physical examination and vital signs are normal or clinically irrelevant to the study.
• Volunteers receiving pharmacological treatment may be included if the dosage has remained stable for at least three months prior to study initiation.
• Individuals undergoing treatment for diabetes will be excluded.
• Participants must be capable of understanding the study requirements, willing to provide written informed consent, and able to comply with all study procedures and timelines.
• Body weight must have remained stable (±5%) during the three months preceding study initiation.

You may not qualify if:

• Presence of significant functional or structural abnormalities of the digestive system, including but not limited to congenital malformations, angiodysplasia, active peptic ulcer disease, chronic inflammatory or malabsorption disorders, hiatal hernia, or chronic gastroesophageal reflux.
• High alcohol consumption, defined as \>14 units per week for women and \>20 units per week for men.
• Pregnancy or lactation at the time of screening.
• History of surgical procedures resulting in permanent alterations of the digestive system (e.g., gastroduodenostomy) or joint replacement surgery (hip or knee).
• Diagnosis of arthritis.
• History of any liver disease, with the exception of non-alcoholic fatty liver disease.
• Diagnosis of any type of cancer, current cancer treatment, or history of cancer treatment within the past five years.
• Known allergy or hypersensitivity to any component of the investigational product or to any food that could interfere with study participation and follow-up.
• Presence of cognitive and/or psychological impairment that could affect study compliance.
• Anticipated poor adherence or, in the opinion of the investigator, inability to comply with study procedures.
• Engagement in night-shift work.
• Current use of dietary supplements that may interfere with study outcomes (e.g., nutraceuticals containing compounds with potential weight loss effects).
• Ongoing treatment for weight loss or diabetes.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Center for Nutrition Research

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• María Ángeles Zulet, PhD

  Center for Nutrition Research

  PRINCIPAL INVESTIGATOR

• Fermín Milagro, PhD

  Center for Nutrition Research

  STUDY CHAIR

• Idoia Ibero

  Center for Nutrition Research

  STUDY CHAIR

• María Hernández

  Center for Nutrition Research

  STUDY CHAIR

• Miguel López, PhD

  Center for Nutrition Research

  STUDY CHAIR

• Verónica Ciaurriz

  Center for Nutrition Research

  STUDY CHAIR

• Carlos J González, PhD

  Center for Nutrition Research

  STUDY CHAIR

• Salomé Pérez

  Center for Nutrition Research

  STUDY CHAIR

• Marián Pueyo

  Center for Nutrition Research

  STUDY CHAIR

Central Study Contacts

María Ángeles Zulet, PhD

CONTACT

+34948425600; mazulet@unav.es

Fermín Milagro, PhD

CONTACT

+34948425600; fmilagro@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 parallel groups, 12-week, randomized nutritional intervention

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 10, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)