Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06622616

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

In visit 1 (basal visit), the participant will provide a stool sample (for microbiota analysis), a fasting blood sample (for biochemical, genetic, epigenetic and metabolomic analysis) and then go to the nutrition consultation where medical history data and lifestyle habits will be collected, a nutritional assessment will be made and the completed questionnaires will be corrected. In addition, they will be provided with continuous glucose monitoring sensors and an activity wristband to record lifestyle patterns. The glucose sensors will be used for the first 14 and last 14 days of the intervention. In addition, all participants will be provided with the required amount of product until the next visit, as well as how to consume, store, and ideas for consumption. In addition, a balanced (normoprotein) and varied diet and physical activity guidelines will be explained.

In the second visit (final), the participant will again submit a stool sample (for microbiota analysis), a fasting blood sample will be taken (for biochemical, epigenetic and metabolomic analysis) and then they will go to the nutrition clinic where a nutritional assessment will be made and the completed questionnaires will be corrected. In addition, the glucose sensor and the activity bracelet will be removed.

During the intervention phase of the study, participants will be able to come to the center for the collection of more product as well as for the review and troubleshooting of any problems with the sensors that may arise. In turn, halfway through the study (6 weeks), a telephone survey will be conducted to participants to avoid travel, in order to assess the degree of adherence and possible adverse effects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. insulin resistance (HOMA)

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria I Espinosa, PhD.

CONTACT

[email protected]

+34917278100

Ricardo Ramos, IMDEA FOOD deputy director

CONTACT

Sponsors and collaborators

Lead sponsor

María Isabel Espinosa

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DIBAN

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.