Glucose Metabolism DisordersNCT06051318
Relationship Between Individual Effect of Diet on Postprandial Glycemia and Gut Microbiome Profile in Healthy Subjects
A study testing Standardized breakfast A and Standardized breakfast B in people with Glucose Metabolism Disorders and Health Behavior, run by BiomeHub Biotechnology Company at 1 site in Brazil.
Trial summary
When all the food we eat is digested, it will increase blood glucose. Two people can have different glucose blood levels to the same food and one reason can be bacteria live in our gut. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders, Health Behavior, Diabetes
- What is being tested?
- Standardized breakfast A and Standardized breakfast B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jun 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI > 18.5 and < 30
- Willing to use an intradermal continuous glucose monitoring sensor during the 10-day study
- Own a mobile phone with NFC technology
- Willing to provide a fecal swab sample and a stool sample
- Understanding, agreement, and signing of the approved Informed Consent Form (ICF) by the Ethics Committee (CEP)
Who cannot join
- Pregnant or lactating women
- Diagnosis of any gastrointestinal disorder or disease (Irritable Bowel Syndrome, Ulcerative Colitis, Crohn's Disease)
- Intolerance or allergy to any diet ingredient
- Autoimmune disorder (Lupus, Type 1 Diabetes, Celiac Disease) or infectious disease
- Diabetes diagnosis
- Cancer diagnosis, acute myocardial infarction, or stroke in the last 6 months
Show all 13Show fewer
- Use of hypoglycemic medication
- Use of proton pump inhibitors, immunosuppressants, or antimicrobials in the last 3 months
- Use of laxative medications in the last 30 days
- Underwent invasive procedures or surgery in the last 6 months
- Admission to ICU in the last 2 years
- Participation in any experimental study or ingestion of any experimental drug within twelve months prior to the start of this study, in accordance with RDC 251/97
- Inability to read and understand the informed consent form
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
BiomeHub
Florianópolis, Santa Catarina, 88054700
Bianca L Teixeira, PhD, 554899183-3662, pesquisa.clinica@biome-hub.com
About this study
Official title: Individual Effect of Diet on Postprandial Glycemic Response and Its Relationship with Gut Microbiome Profile in Healthy Subjects: Protocol for a Series of Randomized N-of-1 Trials
When all the food we eat is digested, it will increase blood glucose. Two people can have different glucose blood levels to the same food and one reason can be bacteria live in our gut. There are more than a thousand bacteria species in our gastrointestinal tract that have an important role in the proper functioning of our body, so our gut microbiome is a key piece for our nutrition and blood glucose control.
Nowadays, one of the major public health concerns is the rise of people with diabetes (a disease characterized by an increase in blood glucose) and the increase in obesity, in which one of several risks is diabetes. There are multiple reasons for people develop those diseases, however, some care on diet management can prevent, delay, or improve the effects of these illnesses. Therefore, this study proposes studying the blood glucose variation between healthy volunteers and if there is a relationship between that variation and the intestinal bacteria present. These results can help doctors and nutritionists elaborate a personalized diet for people who need blood glucose level control.
The investigators are recruiting volunteers aged 18 to 60, healthy, living at Florianopolis and the surroundings to participate in this crossover randomized N-of-1 study. The participants must collect fecal samples. After collection, the participants will meet the investigators and receive a kit containing ten standardized breakfasts, with two kinds of muffins, and a kit containing a glucose monitor (Abbott Freestyle Libre-CE marked) to monitor their blood sugar levels. The volunteers must have breakfast with the standardized meals and monitor the fasting glucose blood and postprandial glucose blood levels for ten consecutive days. Besides, they must take notes (like a diet diary) about all the food they ingest during the day in ten days of the study.
Read the detailed description
Choice of design: The study is a N-of-1 randomized series trial with multiple crossovers.
Study population: This study will monitor healthy volunteers and they will be recruited via social media like Facebook, Instagram, and LinkedIn platforms.
Screening Assessment: The participants will be selected based on inclusion and exclusion criteria by study management researchers. Recruitment will be done via e-mail the participant will receive all the information about the study including the consent term and the anthropometric questionnaire. If he/she accepts it will be sent a collection kit for the fecal samples to the participant's address.
Study duration: Each participant will take part in the study for ten days. Dietary intervention: The participants will receive 10 standardized meals, divided into two kinds of muffins, which consist of a low-carbohydrate diet and a vegan one. The low-carb muffin will have a glycemic control characteristic, with a low carbohydrate content, below 45% of the carbohydrates recommended by the Acceptable Macronutrient Distribution Ranges (AMDR), while the vegan muffin will consist entirely of plant-based foods in the recommended macronutrient proportions. Both muffins will be similar in calories and standardized at 25% of daily calories, equivalent to the caloric distribution of breakfast.
After the fecal collection, the participant must introduce the standardized meals and the glucose monitoring device inserted. The meal order must obey the randomization established. Before breakfast, the participant will have to measure the fasting glucose with the monitoring glucose device and then eat the breakfast. After ingesting the muffin, the participant will measure glucose levels every 30 minutes over a 2-hour period, totaling four postprandial glucose measurements. Participants are free to eat whatever they wish at all other times, but they will report every meal in a diet diary. Together with breakfast, they can drink coffee without milk and sugar or water. The volunteers shouldn't do fasting exercises either for about two hours after breakfast.
Anthropometry dietary and lifestyle questionnaire: Before the participants initiate the intervention they will answer a simple questionnaire about their weight, height, gastrointestinal symptoms, stool shape, drugs in use, antibiotics, proton pump inhibitors use, any diagnosis of chronic disease, kind of diet, and activity information.
Digital devices: Participants will be asked to record daily dietary intake on an online platform, like Google Sheets. The continuous glucose monitor (Freestyle Libre, CGM) will be inserted on the back of the upper arm by themselves, or if they prefer it can be inserted by one of the researchers when they receive all the study kits. Subcutaneous interstitial fluid glucose will be measured before breakfast and two hours later. At the end of the intervention period, the CGM can be removed at home. Researchers' email addresses and cellphone number will be always available to participants to make any question.
Digital app: Participants will need to download the app FreeStyle LibreLink for the subcutaneous interstitial fluid glucose to be measured with their cellphones.
Sample size: The sample size was calculated through simulation, assuming a Gaussian multilevel model, comparing two diets with random intercept and diet effects per participant. The simulation assumptions were validated with a nutritionist to ensure plausible values for the outcome, intra-individual and inter-individual outcome variability, and individual effect variability. A minimum clinically significant effect on postprandial blood glucose of 15 mg/dL was determined. This value was used to define the expected range for 95% of true individual effects. The number of cycles was fixed at five to minimize the study time for each recruited participant. Under these assumptions, the simulation of 10,000 series of N-of-1 clinical trials determined it would be recruiting 80 participants.
- Being tested
- Standardized breakfast A, Standardized breakfast B
- Keywords
- Glycemic response, Precision nutrition, Gut Microbiome, Biomarkers, Sequencing analysis, N-of-1 trials
- Medical subject headings
- Glucose Metabolism Disorders, Health Behavior, Diabetes Mellitus, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized breakfast AOther
Participants will initiate the interventional period by eating the low-carb muffin first following the established muffin order for the next days.
Standardized breakfast BOther
Participants will initiate the interventional period by eating the vegan muffin first following the established muffin order for the next days.
| Study group | Role | What they receive |
|---|---|---|
| Standardized breakfast A | Experimental | Consumption order: Participants will initiate the interventional period by eating the low-carb muffin first following the established muffin order for the next days. Receives: Other: Standardized breakfast A |
| Standardized breakfast B | Experimental | Consumption order: Participants will initiate the interventional period by eating the vegan muffin first following the established muffin order for the next days. Receives: Other: Standardized breakfast B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting subcutaneous interstitial fluid glucose measured by continuous glucose monitor (CGM)
All participants will measure fasting subcutaneous interstitial fluid glucose before breakfast with CGM device during 10 days of intervention. The device measures subcutaneous interstitial glucose in the mg/dL unit and the reading is done through the device's app by cell phone approximation. Data is retained in the app and will be shared with researchers.
Measured: 0 min
Postprandial subcutaneous interstitial fluid glucose measured by continuous glucose monitor (CGM)
All participants will measure postprandial subcutaneous interstitial fluid glucose every 30 minutes over two hours after breakfast with CGM device during 10 days of intervention. The device measures subcutaneous interstitial glucose in the mg/dL unit and the reading is done through the device's app by cell phone approximation. Data is retained in the app and will be shared with researchers.
Measured: 0 min
Secondary outcomes (1)
Participant's gut microbiome species richness
Gut microbiome profile will be performed by 16S sequencing from participant's fecal sample.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start6 Jun 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a N-of-1 randomized series trial with multiple crossovers.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BiomeHub Biotechnology Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caetana P. Zamparette, PhD, Study chair, Researcher fellowBianca L. Teixeira, PhD, Study chair, Clinical researchGiuliano Netto, Msc, Study chair, Bioinformatics development and maintenanceAline FR Sereia, PhD, Study chair, Chief Operating OfficerAna P. Christoff, PhD, Study chair, Researcher R&DDaniela C Bastiani, B.Sc, Study chair, Laboratory managerFernanda RG Piazza, Msc, Study chair, NutricionistMichele P Rode, PhD, Study chair, Product Owner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051318
- Sponsor's protocol ID
- 68325123.0.0000.5355
- Status last verified
- Oct 2024
- First submitted
- 12 Sep 2023
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't have a plan yet.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Effect of Diet on Postprandial Glycemic Response and Its Relationship with Gut Microbiome Profile in Healthy Subjects: Protocol for a Series of Randomized N-of-1 Trials
- ClinicalTrials.gov ID
- NCT06051318
- Acronym / sponsor ID
- 68325123.0.0000.5355
- Keywords
- Glycemic response, Precision nutrition, Gut Microbiome, Biomarkers, Sequencing analysis, N-of-1 trials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- BiomeHub Biotechnology CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 Sep 2023 (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.
When all the food we eat is digested, it will increase blood glucose. Two people can have different glucose blood levels to the same food and one reason can be bacteria live in our gut. There are more than a thousand bacteria species in our gastrointestinal tract that have an important role in the proper functioning of our body, so our gut microbiome is a key piece for our nutrition and blood glucose control.
Nowadays, one of the major public health concerns is the rise of people with diabetes (a disease characterized by an increase in blood glucose) and the increase in obesity, in which one of several risks is diabetes. There are multiple reasons for people develop those diseases, however, some care on diet management can prevent, delay, or improve the effects of these illnesses. Therefore, this study proposes studying the blood glucose variation between healthy volunteers and if there is a relationship between that variation and the intestinal bacteria present. These results can help doctors and nutritionists elaborate a personalized diet for people who need blood glucose level control.
The investigators are recruiting volunteers aged 18 to 60, healthy, living at Florianopolis and the surroundings to participate in this crossover randomized N-of-1 study. The participants must collect fecal samples. After collection, the participants will meet the investigators and receive a kit containing ten standardized breakfasts, with two kinds of muffins, and a kit containing a glucose monitor (Abbott Freestyle Libre-CE marked) to monitor their blood sugar levels. The volunteers must have breakfast with the standardized meals and monitor the fasting glucose blood and postprandial glucose blood levels for ten consecutive days. Besides, they must take notes (like a diet diary) about all the food they ingest during the day in ten days of the study.
Detailed description
Choice of design: The study is a N-of-1 randomized series trial with multiple crossovers.
Study population: This study will monitor healthy volunteers and they will be recruited via social media like Facebook, Instagram, and LinkedIn platforms.
Screening Assessment: The participants will be selected based on inclusion and exclusion criteria by study management researchers. Recruitment will be done via e-mail the participant will receive all the information about the study including the consent term and the anthropometric questionnaire. If he/she accepts it will be sent a collection kit for the fecal samples to the participant's address.
Study duration: Each participant will take part in the study for ten days. Dietary intervention: The participants will receive 10 standardized meals, divided into two kinds of muffins, which consist of a low-carbohydrate diet and a vegan one. The low-carb muffin will have a glycemic control characteristic, with a low carbohydrate content, below 45% of the carbohydrates recommended by the Acceptable Macronutrient Distribution Ranges (AMDR), while the vegan muffin will consist entirely of plant-based foods in the recommended macronutrient proportions. Both muffins will be similar in calories and standardized at 25% of daily calories, equivalent to the caloric distribution of breakfast.
After the fecal collection, the participant must introduce the standardized meals and the glucose monitoring device inserted. The meal order must obey the randomization established. Before breakfast, the participant will have to measure the fasting glucose with the monitoring glucose device and then eat the breakfast. After ingesting the muffin, the participant will measure glucose levels every 30 minutes over a 2-hour period, totaling four postprandial glucose measurements. Participants are free to eat whatever they wish at all other times, but they will report every meal in a diet diary. Together with breakfast, they can drink coffee without milk and sugar or water. The volunteers shouldn't do fasting exercises either for about two hours after breakfast.
Anthropometry dietary and lifestyle questionnaire: Before the participants initiate the intervention they will answer a simple questionnaire about their weight, height, gastrointestinal symptoms, stool shape, drugs in use, antibiotics, proton pump inhibitors use, any diagnosis of chronic disease, kind of diet, and activity information.
Digital devices: Participants will be asked to record daily dietary intake on an online platform, like Google Sheets. The continuous glucose monitor (Freestyle Libre, CGM) will be inserted on the back of the upper arm by themselves, or if they prefer it can be inserted by one of the researchers when they receive all the study kits. Subcutaneous interstitial fluid glucose will be measured before breakfast and two hours later. At the end of the intervention period, the CGM can be removed at home. Researchers' email addresses and cellphone number will be always available to participants to make any question.
Digital app: Participants will need to download the app FreeStyle LibreLink for the subcutaneous interstitial fluid glucose to be measured with their cellphones.
Sample size: The sample size was calculated through simulation, assuming a Gaussian multilevel model, comparing two diets with random intercept and diet effects per participant. The simulation assumptions were validated with a nutritionist to ensure plausible values for the outcome, intra-individual and inter-individual outcome variability, and individual effect variability. A minimum clinically significant effect on postprandial blood glucose of 15 mg/dL was determined. This value was used to define the expected range for 95% of true individual effects. The number of cycles was fixed at five to minimize the study time for each recruited participant. Under these assumptions, the simulation of 10,000 series of N-of-1 clinical trials determined it would be recruiting 80 participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a N-of-1 randomized series trial with multiple crossovers.
| Arm | Type | Receives |
|---|---|---|
| Standardized breakfast A | Experimental | Other: Standardized breakfast AConsumption order: Participants will initiate the interventional period by eating the low-carb muffin first following the established muffin order for the next days. |
| Standardized breakfast B | Experimental | Other: Standardized breakfast BConsumption order: Participants will initiate the interventional period by eating the vegan muffin first following the established muffin order for the next days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI > 18.5 and < 30
- Willing to use an intradermal continuous glucose monitoring sensor during the 10-day study
- Own a mobile phone with NFC technology
- Willing to provide a fecal swab sample and a stool sample
- Understanding, agreement, and signing of the approved Informed Consent Form (ICF) by the Ethics Committee (CEP)
Key exclusion criteria (13 listed)
- Pregnant or lactating women
- Diagnosis of any gastrointestinal disorder or disease (Irritable Bowel Syndrome, Ulcerative Colitis, Crohn's Disease)
- Intolerance or allergy to any diet ingredient
- Autoimmune disorder (Lupus, Type 1 Diabetes, Celiac Disease) or infectious disease
- Diabetes diagnosis
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 |
|---|---|---|
| Standardized breakfast AParticipants will initiate the interventional period by eating the low-carb muffin first following the established muffin order for the next days. | Other | Standardized breakfast A |
| Standardized breakfast BParticipants will initiate the interventional period by eating the vegan muffin first following the established muffin order for the next days. | Other | Standardized breakfast B |
Primary outcome
Fasting subcutaneous interstitial fluid glucose measured by continuous glucose monitor (CGM)
Time frame: 0 min
All participants will measure fasting subcutaneous interstitial fluid glucose before breakfast with CGM device during 10 days of intervention. The device measures subcutaneous interstitial glucose in the mg/dL unit and the reading is done through the device's app by cell phone approximation. Data is retained in the app and will be shared with researchers.
Postprandial subcutaneous interstitial fluid glucose measured by continuous glucose monitor (CGM)
Time frame: 0 min
All participants will measure postprandial subcutaneous interstitial fluid glucose every 30 minutes over two hours after breakfast with CGM device during 10 days of intervention. The device measures subcutaneous interstitial glucose in the mg/dL unit and the reading is done through the device's app by cell phone approximation. Data is retained in the app and will be shared with researchers.
1 secondary outcome
Participant's gut microbiome species richness
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No. We don't have a plan yet.
Related trials for Glucose Metabolism Disorders
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
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. This study is not recruiting at the moment.
Caetana P. Zamparette, PhD study chair
Researcher fellow
Bianca L. Teixeira, PhD study chair
Clinical research
Giuliano Netto, Msc study chair
Bioinformatics development and maintenance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized breakfast A and Standardized breakfast B in people with Glucose Metabolism Disorders and Health Behavior, run by BiomeHub Biotechnology Company at 1 site in Brazil.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luiz Felipe V. de Oliveira, PhD (+554830121322, felipe@biome-hub.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting subcutaneous interstitial fluid glucose measured by continuous glucose monitor (CGM) (time frame: 0 min). The study lists 2 primary outcomes in all. 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 24 Oct 2024.