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NCT06622616Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 2 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
30 Sept 2024
Start date
Jan 2025
Primary completion date
Dec 2025
Lead sponsor
María Isabel Espinosa
NCT number
NCT06622616

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From Jan 2025 to the primary completion date, Dec 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.).
  • 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).

Other

  • BMI \< 18 or ≥ 35.
  • Pregnant or breastfeeding women.
  • Being a socially vulnerable person.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.