Overweight Clinical Trial
Official title:
Design of Healthy and Sustainable Food and Ingredients Based on the Application of the Circular Economy
Verified date | January 2023 |
Source | Clinica Universidad de Navarra, Universidad de Navarra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 Deal, the "Farm to Fork" strategy, or the Common Agricultural Policy, among others. The objective of this study, is to evaluate the nutritional effect of the developed products and their impact on the improvement and/or prevention of health problems (diabetes, intestinal dysbiosis), as well as to design and evaluation of the effect on health of a vegetable protein-based nutraceutical that also includes fiber and resistant starch.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | University of Navarra. Center for Nutrition Research. | Pamplona | Navarra |
Lead Sponsor | Collaborator |
---|---|
Clinica Universidad de Navarra, Universidad de Navarra |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of fecal microbiota from baseline to week 3. | Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology. | The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of weight from baseline to week 3 (weighing machine) | Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg. | The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of body mass index from baseline to week 3. | Body mass index will be calculated as follows: weight (kg)/ height (cm)2. | The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Height at baseline. | Height of participants will be measured by stadiometer and reported in meters. | The Time Frame contains one time point: Clinical Investigation Day 1 (at baseline). | |
Secondary | Change of waist circumference from baseline to week 3. | Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters. | The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of glucose concentration from baseline to week 3. | Change of glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL. | The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of insulin concentration from baseline to week 3. | Change of insulin levels of participants in fasting condition will be analyzed by ELISA kit and reported in mU/L. | The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of HOMA index from baseline to week 3. | Change of HOMA index of participants in fasting condition will be calculated by the following formula: insulin (µU/ml) x glucose (mmol/l)/22,5. | The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of dietary intake from baseline to week 3. | Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire. | The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of hunger from baseline to week 3. | The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome. | The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of fullness from baseline to week 3. | The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome. | The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of satisfaction from baseline to week 3. | The change in satisfaction of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome. | The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of want to eat something else sensation from baseline to week 3. | The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome. | The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of thirst from baseline to week 3. | The change in thirst of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome. | The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Change of gastrointestinal symptoms from baseline to week 3. | Gastrointestinal symptoms will be analyzed by a gastrointestinal symptom questionnaire. | The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention). | |
Secondary | Nutraceutical acceptance at week 3. | Nutraceutical acceptance will be analyzed by acceptance questionnaire. | The Time Frame contains Clinical Investigation Day 2 (after 3 weeks of intervention). |
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