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

Sponsor
María Isabel Espinosa
Study ID
NCT06622616
Status
Not Yet Recruiting

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Conditions

  • Insulin Resistance
  • Type 2 Diabetes Mellitus with Features of Insulin Resistance

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSIS — DIETARY_SUPPLEMENT
    The study will have two arms, the functional group with A. domesticus powder (n=60) and a placebo group that will take a vegetable protein powder with a similar macronutrient composition (n=60). This population will be classified according to sex and BMI, and their nutritional-metabolic status (insulin resistance or not). The study will include analysis of phenotypic data collection (medical history, lifestyle, diet, etc.); biochemical data: glucose, lipid, iron profile, blood count, and analysis of inflammation markers; genotyping, epigenetic analysis (methylation and mi-RNAs), targeted metabolomics (glycome and tryptophan) and metagenomic analysis of stool (16s rRNA sequencing for taxonomic identification study). Using continuous monitoring devices (glucose monitoring using a sensor and physical activity using an activity bracelet), lifestyle parameters (physical activity, circadian rhythms, sleep, stress, etc.) and blood glucose will be evaluated.

Study Details

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.

Key Dates

First listed
Oct 2, 2024
Start date
Jan 31, 2025
Status verified
Sep 2024
Primary completion
Dec 31, 2025
Completion
Nov 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study Group
    Los participantes consumirán 2 porciones de producto con polvo de A. domesticus (15 g. cada una) que podrán consumir al gusto en diferentes recetas. El producto estará incluido dentro de un plan de alimentación saludable normoproteico. Se les recomendará continuar con su actividad física habitual durante las 12 semanas de duración del estudio.
  • Placebo Comparator: Control Group
    Participants will consume 2 portions of a product with a nutritional value similar to the study product, one at breakfast and one at dinner. The product will be included in a healthy, normoprotein diet plan. They will be advised to continue their usual physical activity during the 12 weeks of the study.

Primary Outcome Measure

insulin resistance (HOMA) [ Time Frame: 3 months ]

Central Contacts

  • Maria I Espinosa, PhD.
    +34917278100
    [email protected]
  • Ricardo Ramos, IMDEA FOOD deputy director

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