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

NCT06622616 | Not Yet Recruiting

• 2 other identifiers: IMDEA FOODHORIZON-EIC-2023-PATHFINDER
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Acheta Domesticus; Insect powder; Insulin resistance; microbiota; Artificial Inteligence

Outcome Measures

Primary Outcomes (1)

• insulin resistance (HOMA)

  The primary endpoint will be changes in insulin resistance values after 3 months of intervention.

  3 months

Study Arms (2)

Study Group

EXPERIMENTAL

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.

Dietary Supplement: EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSIS

Control Group

PLACEBO COMPARATOR

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.

Dietary Supplement: EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSIS

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.

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• María Isabel Espinosa: lead
• Biomedical Research Institute Sols-Morreale (CSIC-UAM): collaborator
• Centro de BiologÃ-a Molecular Severo Ochoa, Spain (CBMSO): collaborator
• Epidisease S.L: collaborator
• NUTRINSECT: collaborator

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Maria I Espinosa, PhD.

CONTACT

+34917278100; mariaisabel.espinosa@imdea.org

Ricardo Ramos, IMDEA FOOD deputy director

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study will be masked by using identical packaging for both the study group and the control group (placebo), which participants will consume at home or at the place where they eat, during the 12 weeks of the intervention. The packaging of the products will be carried out by the company supplying A. domesticus powder, Nutrinsect SRL (Italy), which is authorised to produce A. domesticus powder according to EFSA approval. The researchers will administer the product (with identical external appearance for both groups) individually to each participant. The randomisation will be carried out blindly, so that each of the participants and the researcher will not know which group (study or control) they have received. For this purpose, the product under study will be labeled with the protocol code and the letters A or B (or batch number) that will correspond to the functional and/or control product.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: A pilot nutritional intervention study will be conducted that will be longitudinal, prospective, double-blind, randomized and parallel. 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).

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 2, 2024

Record last verified: 2024-09