Actively Recruiting
Impact of Satiating Compounds and Hypocaloric Diet on Weight, Cardiometabolic and Osteoarticular Health in Obesity
Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2025-09-10
144
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of Satiating Compounds and Hypocaloric Diet on Weight, Cardiometabolic and Osteoarticular Health in Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years.
- Overweight or obese with BMI between 27.0 and 39.9 kg/m2.
- Normal or clinically irrelevant physical examination and vital signs.
- Stable dose of any pharmacological treatment for at least three months before the study.
- Able to understand study requirements and willing to provide written consent.
- Body weight stable within ±15% in the three months before the study.
- No treatment for diabetes.
You will not qualify if you...
- Significant functional or structural digestive system abnormalities.
- High alcohol consumption (more than 14 units/week for women, more than 20 units/week for men).
- Pregnant or breastfeeding at screening.
- History of digestive system surgery or joint replacement surgery.
- Diagnosis of arthritis.
- History of liver disease except non-alcoholic fatty liver disease.
- Diagnosis or treatment of any cancer within past five years.
- Known allergy or hypersensitivity to study product or interfering foods.
- Cognitive or psychological impairments affecting compliance.
- Anticipated poor adherence or inability to comply.
- Night-shift work.
- Current use of dietary supplements affecting weight loss.
- Ongoing treatment for weight loss or diabetes.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Center for Nutrition Research
Pamplona, Navarre, Spain, 31008
Actively Recruiting
Research Team
M
María Ángeles Zulet, PhD
CONTACT
F
Fermín Milagro, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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