NUTRITIONAL INTERVENTION STUDY to EVALUATE the EFFECT of ACHETA DOMESTICUS POWDER CONSUMPTION on GLUCOSE HOMEOSTASIS and INTESTINAL DYSBIOSIS in HEALTHY and PREDIABETIC POPULATION. (DIBAN)
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.
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria I Espinosa, PhD.
- Phone Number: +34917278100
- Email: mariaisabel.espinosa@imdea.org
Study Contact Backup
- Name: Ricardo Ramos, IMDEA FOOD deputy director
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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. |
|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
insulin resistance (HOMA)
Time Frame: 3 months
|
The primary endpoint will be changes in insulin resistance values after 3 months of intervention.
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMDEA FOOD
- HORIZON-EIC-2023-PATHFINDER (Other Grant/Funding Number: EUROPEAN COMISION)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.