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New treatment option for Obesity
Official title Impact of Satiating Compounds and Hypocaloric Diet on Weight, Cardiometabolic and Osteoarticular Health in Obesity
ClinicalTrials.gov ID: NCT07165548
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join 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.
You likely can't join if
- Presence of significant functional or structural abnormalities of the digestive system, including but not limited to congenital malformations...
- 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...
- Diagnosis of arthritis.
- History of any liver disease, with the exception of non-alcoholic fatty liver disease.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Pamplona, Navarre, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pamplona, Navarre, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.