Status:
COMPLETED
Circular Economy and the Design of Healthy and Sustainable Food and Ingredients
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Overweight
Sustainability
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
There is a need to change eating patterns towards healthier diets with new sources of non-animal protein, obtained through more sustainable systems in line with strategies such as the European Green D...
Detailed Description
This study is designed as a 3-week, randomised, parallel study, focused on overweight/obese men and women between 20 and 65 years old. All participants attend the Nutrition Intervention Unit of the C...
Eligibility Criteria
Inclusion
- Age: 20-65 years.
- Body mass index: 25-29.9 kg/m2
- Physical examination and vital signs normal or clinically irrelevant to the experiment.
- Volunteers undergoing pharmacological treatment will be maintained if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function, antidiabetics and stomach protectors.
- Subjects must be able to understand and be willing to sign the informed consent, and must comply with all the procedures and requirements of the study.
- Subjects have to present a stable weight (+/-3kg) in the three months prior to the start of the study.
Exclusion
- Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
- Subjects with frecuent flatulence, diarrhea and intestinal discomfort.
- Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
- Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
- Women who are breastfeeding or pregnant.
- Subjects with liver disease.
- Subjects with some type of cancer or undergoing treatment for it, or who have not had a period of at least 5 years since its eradication.
- Subjects with allergies to any component of the product under study or any other food that interferes and makes it difficult to monitor the study.
- Subjects who present some type of cognitive and/or psychic impairment.
- Subjects in whom poor collaboration is expected or who, in the opinion of the investigator, have difficulties in following the study procedures.
- Subjects who follow some type of supplementation that interferes with the study: probiotics, supplements rich in fiber, laxatives, protein supplements, etc.
- Subjects who are immersed in some treatment for weight loss.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05394948
Start Date
October 1 2022
End Date
November 30 2022
Last Update
May 23 2024
Active Locations (1)
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1
University of Navarra. Center for Nutrition Research.
Pamplona, Navarre, Spain, 31008