Impact of Satiating Compounds and Hypocaloric Diet on Wei... | NCT07165548

NCT07165548

Status Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Height	Height of participants will be measured by stadiometer and reported in cm.	Clinical Investigation Day 1
Body mass index	Body mass index will be calculated as follows: weight (kilograms)/ height (m)2

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Name	Role	Phone	Extension	Email
María Ángeles Zulet, PhD	Contact	+34948425600	806317	mazulet@unav.es
Fermín Milagro, PhD	Contact	+34948425600	806553	fmilagro@unav.es

Name	Affiliation	Role
María Ángeles Zulet, PhD	Center for Nutrition Research	Principal Investigator
Fermín Milagro, PhD	Center for Nutrition Research	Study Chair
Idoia Ibero

ID	Term
D009765	Obesity
D050177	Overweight
D015431	Weight Loss

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001836	Body Weight Changes