An interventional study of Dietary recommendations including experimental nutraceutic. and Dietary recommendations including control nutraceutic. in Overweight, Sustainability and Food, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Completed at 1 site in Spain. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Not applicable, Interventional, and Treatment
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.
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 Center for Nutrition Research in the University of Navarra for 2 times during the intervention (day 1 and day 21).
RECRUITMENT AND SCREENING:
The recruitment and screening of participants will be carried out through a Google Form questionnaire and by a phone call. At the same time, the database of people interested in participating in nutritional studies of the Center for Nutrition Research will be used, who will be contacted by phone or email to offer them the study. In addition, the study information and the recruitment form will also be posted on the Center for Nutrition Research website for anyone who wants to enroll in the study. On the other hand, the study will be disseminated through the channels available in the University of Navarra (Unclic, Alumni, emails, etc.) and through the placement of informative posters in the different buildings of the University of Navarra, as well as in public and private centers in Navarra, with prior authorization. If it is necessary, the study will be disseminated in the media such as in press, radio and TV.
The staff of the Nutritional Intervention Unit will assess the data provided by the potential participants and those who meet the inclusion criteria will be cited for the first visit of the study, which will take place in the Nutritional Intervention Unit of the Center for Nutrition Research in the University of Navarra. The information sheet and the informed consent will be sent to them beforehand so that they can read it for visit 1.
CLINICAL INVESTIGATION DAY 1 (day 1):
It will be carried out in groups of 10 people, who will attend the facilities of the University of Navarra fasting for at least 10 hours. The volunteers will be received by the nutritionist and the study nurse. Once gathered, proceed as follows:
Those volunteers who want to participate will sign the informed consent. Then, the procedures for taking samples and data will begin.
CLINICAL INVESTIGATION DAY 2 (day 21):
It will be carried out in groups of 10 people, who will have to attend the University of Navarra fasting for at least 10 hours. The volunteers will be received by the nutritionist and the study nurse. Once gathered, proceed as follows:
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 40 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 158 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental group will consume experimental nutraceutic instead of the habitual breakfast during 3 weeks and within a dietary recommendations.
Dietary Supplement: Dietary recommendations including experimental nutraceutic.
Experimental group will consume control nutraceutic instead of the habitual breakfast during 3 weeks and within a dietary recommendations.
Dietary Supplement: Dietary recommendations including control nutraceutic.
Volunteers allocated in the control group will receive every day and during 3 consecutive weeks the experimental nutraceutic instead of the breakfast. Nutraceutical intake will be accompanied by nutritional advice to follow for the 3 weeks of intervention.
Volunteers allocated in the control group will receive every day and during 3 consecutive weeks the control nutraceutic instead of the breakfast. Nutraceutical intake will be accompanied by nutritional advice to follow for the 3 weeks of intervention.
Change of fecal microbiota from baseline to week 3.
Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
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.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of body mass index from baseline to week 3.
Body mass index will be calculated as follows: weight (kg)/ height (cm)2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Height at baseline.
Height of participants will be measured by stadiometer and reported in meters.
Time frame: The Time Frame contains one time point: Clinical Investigation Day 1 (at baseline).
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.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
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.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
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.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
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.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of dietary intake from baseline to week 3.
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
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.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
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.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
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.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
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.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
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.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 3.
Gastrointestinal symptoms will be analyzed by a gastrointestinal symptom questionnaire.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Nutraceutical acceptance at week 3.
Nutraceutical acceptance will be analyzed by acceptance questionnaire.
Time frame: The Time Frame contains Clinical Investigation Day 2 (after 3 weeks of intervention).
Plan to share: No
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Clinica Universidad de Navarra, Universidad de Navarra