Insulin ResistanceDIBANNCT06622616
NUTRITIONAL INTERVENTION STUDY to EVALUATE the EFFECT of ACHETA DOMESTICUS POWDER CONSUMPTION on GLUCOSE HOMEOSTASIS and INTESTINAL DYSBIOSIS in HEALTHY and PREDIABETIC POPULATION.
A study testing EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSIS in people with Insulin Resistance and Type 2 Diabetes Mellitus with Features of Insulin Resistance, run by María Isabel Espinosa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes Mellitus with Features of Insulin Resistance
- What is being tested?
- EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSIS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ricardo Ramos, IMDEA FOOD deputy director contact
About this study
Official title: 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.
Read the 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.
- Being tested
- EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSIS
- Keywords
- Acheta Domesticus, Insect powder, Insulin resistance, microbiota, Artificial Inteligence
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSISDietary 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance (HOMA)
The primary endpoint will be changes in insulin resistance values after 3 months of intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- María Isabel Espinosa
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research Institute Sols-Morreale (CSIC-UAM), Centro de BiologÃ-a Molecular Severo Ochoa, Spain (CBMSO), Epidisease S.L, NUTRINSECT
- Responsible party
- Sponsor-investigator, María Isabel Espinosa, IMDEA Food
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622616
- Sponsor's protocol ID
- IMDEA FOOD
- Other IDs
- HORIZON-EIC-2023-PATHFINDER
- Acronym
- DIBAN
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTRITIONAL INTERVENTION STUDY to EVALUATE the EFFECT of ACHETA DOMESTICUS POWDER CONSUMPTION on GLUCOSE HOMEOSTASIS and INTESTINAL DYSBIOSIS in HEALTHY and PREDIABETIC POPULATION
- ClinicalTrials.gov ID
- NCT06622616
- Acronym / sponsor ID
- DIBAN / IMDEA FOOD
- Keywords
- Acheta Domesticus, Insect powder, Insulin resistance, microbiota, Artificial Inteligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- María Isabel EspinosaUniversity, hospital or other
- Collaborators
- Biomedical Research Institute Sols-Morreale (CSIC-UAM), Centro de BiologÃ-a Molecular Severo Ochoa, Spain (CBMSO), Epidisease S.L, NUTRINSECT
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Dietary Supplement: EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSISLos 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. |
| Control Group | Placebo comparator | Dietary Supplement: EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSISParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSISThe 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. | Dietary supplement | Control Group, Study Group |
Primary outcome
insulin resistance (HOMA)
Time frame: 3 months
The primary endpoint will be changes in insulin resistance values after 3 months of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ricardo Ramos, IMDEA FOOD deputy director contact
Questions about this trial
What is this clinical trial studying?
A study testing EVALUATE THE EFFECT OF ACHETA DOMESTICUS POWDER CONSUMPTION ON GLUCOSE HOMEOSTASIS AND INTESTINAL DYSBIOSIS in people with Insulin Resistance and Type 2 Diabetes Mellitus with Features of Insulin Resistance, run by María Isabel Espinosa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria I Espinosa, PhD. (+34917278100, mariaisabel.espinosa@imdea.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin resistance (HOMA) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.