Not Yet RecruitingNot Applicable

NUTRITIONAL INTERVENTION STUDY to EVALUATE the EFFECT of ACHETA DOMESTICUS POWDER CONSUMPTION on GLUCOSE HOMEOSTASIS and INTESTINAL DYSBIOSIS in HEALTHY and PREDIABETIC POPULATION.

120 participantsStarted 2025-01

Plain-language summary

A nutritional intervention study is proposed to evaluate the association between the consumption of A. domesticus (insect protein) powder and the effect on insulin resistance and the microbiome, in order to generate personalized nutrition strategies through its analysis with artificial intelligence. This study is expected to involve 120 healthy volunteers between 18 and 65 years old, with or without insulin resistance, who will be recruited by IMDEA-Food. This is a 12-week nutritional intervention study, so you must come to Institute IMDEA-Food for a first screening visit (V0) and, if you meet the study inclusion criteria and are still interested in volunteering for the study, you will be informed about the study, sign the informed consent form and be scheduled for 2 more visits (V1 or initial zero-time, and V2 or final) at IMDEA-Food\'s facilities.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion Criteria: * Men and women between 18 and 65 years of age. * Adequate cultural level and understanding of the clinical study. * Agree to participate voluntarily in the study and give their informed consent in writing. Exclusion Criteria: * Subjects with dementia, mental illness or decreased cognitive function that prevents understanding of the study. * Subjects with celiac disease or serious diseases (tumour, immunological, intestinal, metabolic, cardiovascular processes, etc.). * BMI \< 18 or ≥ 35. * Pregnant or breastfeeding women. * Being a socially vulnerable person. * Subjects whit chronic pharmacological treatment for weight loss, insulin or antibiotic treatment in the month prior to the start of the intervention or during it. * Subjects with food allergies, especially to mollusks and their by-products, dust mites, chickpeas or soy (the product may contain traces of soy and gluten). * Subjects who refuse to be monitored by sensors, collect samples, draw blood and nutritional visits. * Subjects who reject the consumption of products made with alternative proteins (insect powder).

What they're measuring

insulin resistance (HOMA)

Timeframe: 3 months

Trial details

NCT IDNCT06622616

SponsorMaría Isabel Espinosa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Maria I Espinosa, PhD.

+34917278100 mariaisabel.espinosa@imdea.org