MicrobiotaSUPERFOOD 19-2NCT05451992
Microbiome-Tailored Food Products Based On Typical Mediterranean Diet Components
A study testing SuperFood in people with Microbiota and Overweight and Obesity, run by University of Bari at 1 site in Italy.
Trial summary
The composition and functions of the microbiome impact human metabolism and health status. Diet plays a fundamental role in shaping the structure of the gut microbiome, modulating the interaction between the gut microbiome and the human host. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Microbiota, Overweight and Obesity, Metabolic Complication
- What is being tested?
- SuperFood
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2021to 15 Dec 2021
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects able to sign the Informed Consent
- Age 30-60 years;
- BMI 25-29.9 kg/m2
- Low adherence to the Mediterranean diet (score between 0-5)
Who cannot join
- Subjects not able to provide informed consent
- obesity (BMI> 30 kg /m2), diabetes, dysthyroidism, food allergies, alterations of the alvo, any intestinal disease, liver, kidney, or other organ/apparatus pathologies, regular use of drugs or food supplements, consumption of antibiotics in the 3 months prior to the experiment or need for a specific diet, pregnancy /lactation.
- SARS-CoV-2 infection
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"
Bari, BA, 70124
About this study
Official title: Beneficial Effect of Mediterranean (MD) Components on the Structure and Functions of Gut Microbiome and Metabolome in Subjects With Low Adherence to MD
The composition and functions of the microbiome impact human metabolism and health status. Diet plays a fundamental role in shaping the structure of the gut microbiome, modulating the interaction between the gut microbiome and the human host. Western dietary patterns including a high consumption of red and processed meat, refined grains and sugars, and dairy products have been associated with a high incidence of chronic diseases. It is widely recognised that there is a higher consumption of plant-based foods in Mediterranean countries than in other Western countries. The Mediterranean diet involves a high intake of fruits, vegetables, legumes, nuts, minimally processed cereals, moderate consumption of fish and a low consumption of saturated fats, meat and dairy products with regular intake of extra virgin olive oil. The Mediterranean diet reduces the incidence of cardiovascular, metabolic and neurodegenerative diseases. Interesting results emerged from the evaluation of the microbiome-metabolome interaction, which shows that individuals with the highest adherence to the Mediterranean diet had much higher levels of short-chain fatty acids (SCFAs) and increased levels of the beneficial fiber-degrading bacteria compared to subjects with low adherence to the Mediterranean diet. The study of the effect on the microbiota of specific foods with anti-inflammatory/antioxidant properties is interesting and of potential clinical impact.
Read the detailed description
The composition and functions of the microbiome impact human metabolism and health status. Dietary habits play a fundamental role in shaping the structure of the gut microbiome, modulating the interactions between the gut microbiome and the human host. Western dietary patterns, including a high consumption of red and processed meat, refined grains and sugars, and dairy products, have been associated with a high incidence of chronic diseases. It is widely recognised that there is a higher consumption of plant-based foods in Mediterranean countries than in other Western countries. The Mediterranean diet involves a high intake of fruits, vegetables, legumes, nuts, minimally processed cereals, moderate consumption of fish and a low consumption of saturated fats, meat and dairy products with regular intake of extra virgin olive oil. The Mediterranean diet (MD) reduces the incidence of cardiovascular, metabolic and neurodegenerative diseases. Interesting results emerged from the evaluation of the microbiome-metabolome interaction, which shows that individuals with the highest adherence to the Mediterranean diet had much higher levels of short-chain fatty acids (SCFAs) and increased levels of the beneficial fiber-degrading bacteria compared to subjects with low adherence to the Mediterranean diet. The study of the effect on the microbiota of specific foods with anti-inflammatory/antioxidant properties is interesting and of potential clinical impact.
Extent and evaluation of current knowledge directly linked to the scientific question(s) to be answered by the clinical study: The Mediterranean diet exerts beneficial effects on health status. Evidence has shown that the two mechanisms by which consuming a Mediterranean diet patterns may contribute to improved metabolic health are modulation of the gastrointestinal microbiota and reduction of metabolic endotoxemia.
Outcomes (efficacy, safety) of completed and number of ongoing clinical studies utilising the same intervention in the same indication: The available evidence focuses on a broader concept of food and nutrient consumption, which do not consider that the beneficial effect of the Mediterranean Diet might due to the synergic and interactive combinations of nutrients, rather than to isolated nutrients.
Level of evidence related to the mechanism of action of the intervention in the planned clinical study population: Although several studies have shown the effects of Mediterranean dietary pattern on health status by modulating intestinal microbiota, a comprehensive evaluation of the synergetic and combined effects of selected dietary pattern on metabolic patterns as well as on the intestinal microbiota and its metabolites is still not totally clarified and recognized.
Objective(s) of the clinical study:
- Primary objective: to explore the effect of a "SuperFood" based on Mediterranean diet components (e.g. dietary fibre, polyphenols, flavonoids and glucosinolates) on the structure and functions of the gut microbiome (bacteria, fungi and viruses) and on the metabolome in subjects with low adherence to Mediterranean Diet.
- Secondary objectives: to explore the effect of a "SuperFood" based on Mediterranean diet components (e.g. dietary fibre, polyphenols, flavonoids and glucosinolates) on the metabolic, inflammatory, and oxidative status, and to define taxonomic and metabolic differences.
Characteristics of the study population (size, age group, sex distribution, inclusion and exclusion criteria; all items with justification!):
Upon signing of the informed consent, 40 healthy volunteers (20 subjects in placebo group and 20 subjects in SuperFood treatment group, comparable sex ratio) with BMI<30 kg/m2 and with low adherence to Mediterranean diet will be enrolled.
Inclusion Criteria:
- Subjects able to sign the Informed Consent
- Age 30-60 years;
- BMI 25-29.9 kg/m2
- Low adherence to the Mediterranean diet (adherence score between 0-5)
Exclusion Criteria:
- Subjects not able to provide informed consent
- obesity (BMI> 30 kg /m2), diabetes, altered thyroid function, food allergies, intestinal disease, liver, kidney, or other organ/apparatus pathologies, regular use of drugs or food supplements, consumption of antibiotics in the 3 months prior to the experiment or need for a specific diet, pregnancy /lactation.
- SARS-CoV-2 infection
Details on sample size and power calculation:
The investigatres considered that a sample of 120 healthy subjects gives sufficient power to detect significant differences regarding certain bacterial strains and metabolites following the consumption of Mediterranean diet components, considering that during the intervention there could be a drop-out rate of 20%.
Design of the clinical study (controlled / uncontrolled; randomised; open / blinded; parallel group / cross over / other; please justify the appropriateness of the selected design) A blinded- and placebo-controlled randomized clinical study of 8 weeks evaluating the possible beneficial effects of a well-selected Mediterranean diet components. Subjects will be randomly assigned to a SuperFood or placebo (blinded) treatment in a 1:1 ratio.
Type of intervention:
The intervention consists of consumption of SuperFood" based on Mediterranean diet components (e.g., dietary fibre, polyphenols, flavonoids and glucosinolates).
- Conditions
- Microbiota, Overweight and Obesity, Metabolic Complication
- Being tested
- Placebo, SuperFood
- Keywords
- Microbiota, Mediterranean diet, Overweight, Metabolic syndrome
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
The group will have to consume a jar every day (approx. 75 ml) which contain (water, malt-dextrins, 0.1% starch, 0.1% guar gum, flavorings and colorants)
SuperFoodDietary supplement
The group will have to consume a jar of superfood (vegetable smoothie) every day. The jar will be filled with approx. 75 ml which corresponds to about 75 g. The superfood formulated by the University of Bolzano on the basis of the results and evidence acquired in collaboration with the Istituto Superiore di Sanità. Composition: pomegranate, walnuts, moringa, broccoli, according to the proportions indicated in Annex 2. This mixture has been analyzed by an external laboratory and authorized for human use
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Control group that will consume a placebo product Receives: Dietary Supplement: Placebo |
| SuperFood | Experimental | The superfood group will have to consume the superfood product (vegetable smoothie) Receives: Dietary Supplement: SuperFood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of SuperFood on gut Microbiota and metabolome
Analysis of the gut microbiome by DNA extraction from faecal samples and high-throughput rRNA gene-targeted amplicon sequencing Gut metabolome: Faecal samples will be analysed by GC-MS and 1H-NMR. Faecal phenolic compounds and their derivatives as well as endocannabinoids will be also analysed. The amount of faecal SCFA before/after dietary intervention will be used as markers for selecting individuals for further meta-proteomic analysis
Measured: 2 months
Secondary outcomes (3)
Effects of SuperFood on Body Mass Index
height and weight will be combined to calculate Body Mass Index (BMI, expressed as Kg/m^2). measurements will be recorded in all subjects at enrollment and at the end of follow-up
Measured: 2 months
Effects od SuperFood on serum gluco-lipid profile
Serum glucose (mg/dL), total cholesterol (mg/dL), LDL cholesterol (mg/dL), HDL cholesterol (mg/dL), triglycerides (mg/dL) will be measured at enrollment and at the end of the follow-up
Measured: 2 months
Effects of SuperFood on hormones
Serum levels of adiponectin, leptin, insulin, and glucagone will be measured at enrollment and at the end of the follow-up
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start15 Feb 2021
- Primary completion15 Apr 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, piero portincasa, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451992
- Sponsor's protocol ID
- SuperFood 01
- Acronym
- SUPERFOOD 19-2
- Status last verified
- Jul 2022
- First submitted
- 23 Jun 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vacca M, Celano G, Calabrese FM, Portincasa P, Gobbetti M, De Angelis M. The Controversial Role of Human Gut Lachnospiraceae. Microorganisms. 2020 Apr 15;8(4):573. doi: 10.3390/microorganisms8040573.
PubMed 32326636De Angelis M, Garruti G, Minervini F, Bonfrate L, Portincasa P, Gobbetti M. The Food-gut Human Axis: The Effects of Diet on Gut Microbiota and Metabolome. Curr Med Chem. 2019;26(19):3567-3583. doi: 10.2174/0929867324666170428103848.
PubMed 28462705Vitellio P, Celano G, Bonfrate L, Gobbetti M, Portincasa P, De Angelis M. Effects of Bifidobacterium longum and Lactobacillus rhamnosus on Gut Microbiota in Patients with Lactose Intolerance and Persisting Functional Gastrointestinal Symptoms: A Randomised, Double-Blind, Cross-Over Study. Nutrients. 2019 Apr 19;11(4):886. doi: 10.3390/nu11040886.
PubMed 31010241Bonfrate L, Di Palo DM, Celano G, Albert A, Vitellio P, De Angelis M, Gobbetti M, Portincasa P. Effects of Bifidobacterium longum BB536 and Lactobacillus rhamnosus HN001 in IBS patients. Eur J Clin Invest. 2020 Mar;50(3):e13201. doi: 10.1111/eci.13201. Epub 2020 Feb 12.
PubMed 31960952Portincasa P, De Angelis M, Lammert F, Stokes CS. Medicinal Diets: From Molecules to Nutrients to Foods: Basic and Clinical Implications. Curr Med Chem. 2019;26(19):3372-3375. doi: 10.2174/092986732619190821150547.
PubMed 31564245Portincasa P, Bonfrate L, Vacca M, De Angelis M, Farella I, Lanza E, Khalil M, Wang DQ, Sperandio M, Di Ciaula A. Gut Microbiota and Short Chain Fatty Acids: Implications in Glucose Homeostasis. Int J Mol Sci. 2022 Jan 20;23(3):1105. doi: 10.3390/ijms23031105.
PubMed 35163038
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effect of Mediterranean (MD) Components on the Structure and Functions of Gut Microbiome and Metabolome in Subjects With Low Adherence to MD
- ClinicalTrials.gov ID
- NCT05451992
- Acronym / sponsor ID
- SUPERFOOD 19-2 / SuperFood 01
- Conditions
- Microbiota, Overweight and Obesity, Metabolic Complication
- Keywords
- Microbiota, Mediterranean diet, Overweight, Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 11 Jul 2022 (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.
The composition and functions of the microbiome impact human metabolism and health status. Diet plays a fundamental role in shaping the structure of the gut microbiome, modulating the interaction between the gut microbiome and the human host. Western dietary patterns including a high consumption of red and processed meat, refined grains and sugars, and dairy products have been associated with a high incidence of chronic diseases. It is widely recognised that there is a higher consumption of plant-based foods in Mediterranean countries than in other Western countries. The Mediterranean diet involves a high intake of fruits, vegetables, legumes, nuts, minimally processed cereals, moderate consumption of fish and a low consumption of saturated fats, meat and dairy products with regular intake of extra virgin olive oil. The Mediterranean diet reduces the incidence of cardiovascular, metabolic and neurodegenerative diseases. Interesting results emerged from the evaluation of the microbiome-metabolome interaction, which shows that individuals with the highest adherence to the Mediterranean diet had much higher levels of short-chain fatty acids (SCFAs) and increased levels of the beneficial fiber-degrading bacteria compared to subjects with low adherence to the Mediterranean diet. The study of the effect on the microbiota of specific foods with anti-inflammatory/antioxidant properties is interesting and of potential clinical impact.
Detailed description
The composition and functions of the microbiome impact human metabolism and health status. Dietary habits play a fundamental role in shaping the structure of the gut microbiome, modulating the interactions between the gut microbiome and the human host. Western dietary patterns, including a high consumption of red and processed meat, refined grains and sugars, and dairy products, have been associated with a high incidence of chronic diseases. It is widely recognised that there is a higher consumption of plant-based foods in Mediterranean countries than in other Western countries. The Mediterranean diet involves a high intake of fruits, vegetables, legumes, nuts, minimally processed cereals, moderate consumption of fish and a low consumption of saturated fats, meat and dairy products with regular intake of extra virgin olive oil. The Mediterranean diet (MD) reduces the incidence of cardiovascular, metabolic and neurodegenerative diseases. Interesting results emerged from the evaluation of the microbiome-metabolome interaction, which shows that individuals with the highest adherence to the Mediterranean diet had much higher levels of short-chain fatty acids (SCFAs) and increased levels of the beneficial fiber-degrading bacteria compared to subjects with low adherence to the Mediterranean diet. The study of the effect on the microbiota of specific foods with anti-inflammatory/antioxidant properties is interesting and of potential clinical impact.
Extent and evaluation of current knowledge directly linked to the scientific question(s) to be answered by the clinical study: The Mediterranean diet exerts beneficial effects on health status. Evidence has shown that the two mechanisms by which consuming a Mediterranean diet patterns may contribute to improved metabolic health are modulation of the gastrointestinal microbiota and reduction of metabolic endotoxemia.
Outcomes (efficacy, safety) of completed and number of ongoing clinical studies utilising the same intervention in the same indication: The available evidence focuses on a broader concept of food and nutrient consumption, which do not consider that the beneficial effect of the Mediterranean Diet might due to the synergic and interactive combinations of nutrients, rather than to isolated nutrients.
Level of evidence related to the mechanism of action of the intervention in the planned clinical study population: Although several studies have shown the effects of Mediterranean dietary pattern on health status by modulating intestinal microbiota, a comprehensive evaluation of the synergetic and combined effects of selected dietary pattern on metabolic patterns as well as on the intestinal microbiota and its metabolites is still not totally clarified and recognized.
Objective(s) of the clinical study:
- Primary objective: to explore the effect of a "SuperFood" based on Mediterranean diet components (e.g. dietary fibre, polyphenols, flavonoids and glucosinolates) on the structure and functions of the gut microbiome (bacteria, fungi and viruses) and on the metabolome in subjects with low adherence to Mediterranean Diet.
- Secondary objectives: to explore the effect of a "SuperFood" based on Mediterranean diet components (e.g. dietary fibre, polyphenols, flavonoids and glucosinolates) on the metabolic, inflammatory, and oxidative status, and to define taxonomic and metabolic differences.
Characteristics of the study population (size, age group, sex distribution, inclusion and exclusion criteria; all items with justification!):
Upon signing of the informed consent, 40 healthy volunteers (20 subjects in placebo group and 20 subjects in SuperFood treatment group, comparable sex ratio) with BMI<30 kg/m2 and with low adherence to Mediterranean diet will be enrolled.
Inclusion Criteria:
- Subjects able to sign the Informed Consent
- Age 30-60 years;
- BMI 25-29.9 kg/m2
- Low adherence to the Mediterranean diet (adherence score between 0-5)
Exclusion Criteria:
- Subjects not able to provide informed consent
- obesity (BMI> 30 kg /m2), diabetes, altered thyroid function, food allergies, intestinal disease, liver, kidney, or other organ/apparatus pathologies, regular use of drugs or food supplements, consumption of antibiotics in the 3 months prior to the experiment or need for a specific diet, pregnancy /lactation.
- SARS-CoV-2 infection
Details on sample size and power calculation:
The investigatres considered that a sample of 120 healthy subjects gives sufficient power to detect significant differences regarding certain bacterial strains and metabolites following the consumption of Mediterranean diet components, considering that during the intervention there could be a drop-out rate of 20%.
Design of the clinical study (controlled / uncontrolled; randomised; open / blinded; parallel group / cross over / other; please justify the appropriateness of the selected design) A blinded- and placebo-controlled randomized clinical study of 8 weeks evaluating the possible beneficial effects of a well-selected Mediterranean diet components. Subjects will be randomly assigned to a SuperFood or placebo (blinded) treatment in a 1:1 ratio.
Type of intervention:
The intervention consists of consumption of SuperFood" based on Mediterranean diet components (e.g., dietary fibre, polyphenols, flavonoids and glucosinolates).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboControl group that will consume a placebo product |
| SuperFood | Experimental | Dietary Supplement: SuperFoodThe superfood group will have to consume the superfood product (vegetable smoothie) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects able to sign the Informed Consent
- Age 30-60 years;
- BMI 25-29.9 kg/m2
- Low adherence to the Mediterranean diet (score between 0-5)
Key exclusion criteria (3 listed)
- Subjects not able to provide informed consent
- obesity (BMI> 30 kg /m2), diabetes, dysthyroidism, food allergies, alterations of the alvo, any intestinal disease, liver, kidney, or other organ/apparatus pathologies, regular use of drugs or food supplements, consumption of antibiotics in the 3 months prior to the experiment or need for a specific diet, pregnancy /lactation.
- SARS-CoV-2 infection
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 |
|---|---|---|
| PlaceboThe group will have to consume a jar every day (approx. 75 ml) which contain (water, malt-dextrins, 0.1% starch, 0.1% guar gum, flavorings and colorants) | Dietary supplement | Placebo |
| SuperFoodThe group will have to consume a jar of superfood (vegetable smoothie) every day. The jar will be filled with approx. 75 ml which corresponds to about 75 g. The superfood formulated by the University of Bolzano on the basis of the results and evidence acquired in collaboration with the Istituto Superiore di Sanità. Composition: pomegranate, walnuts, moringa, broccoli, according to the proportions indicated in Annex 2. This mixture has been analyzed by an external laboratory and authorized for human use | Dietary supplement | SuperFood |
Primary outcome
Effects of SuperFood on gut Microbiota and metabolome
Time frame: 2 months
Analysis of the gut microbiome by DNA extraction from faecal samples and high-throughput rRNA gene-targeted amplicon sequencing Gut metabolome: Faecal samples will be analysed by GC-MS and 1H-NMR. Faecal phenolic compounds and their derivatives as well as endocannabinoids will be also analysed. The amount of faecal SCFA before/after dietary intervention will be used as markers for selecting individuals for further meta-proteomic analysis
3 secondary outcomes
Effects of SuperFood on Body Mass Index
Time frame: 2 months
Effects od SuperFood on serum gluco-lipid profile
Time frame: 2 months
Effects of SuperFood on hormones
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Background: PubMed 32326636Vacca M, Celano G, Calabrese FM, Portincasa P, Gobbetti M, De Angelis M. The Controversial Role of Human Gut Lachnospiraceae. Microorganisms. 2020 Apr 15;8(4):573. doi: 10.3390/microorganisms8040573.
- Background: PubMed 28462705De Angelis M, Garruti G, Minervini F, Bonfrate L, Portincasa P, Gobbetti M. The Food-gut Human Axis: The Effects of Diet on Gut Microbiota and Metabolome. Curr Med Chem. 2019;26(19):3567-3583. doi: 10.2174/0929867324666170428103848.
- Background: PubMed 31010241Vitellio P, Celano G, Bonfrate L, Gobbetti M, Portincasa P, De Angelis M. Effects of Bifidobacterium longum and Lactobacillus rhamnosus on Gut Microbiota in Patients with Lactose Intolerance and Persisting Functional Gastrointestinal Symptoms: A Randomised, Double-Blind, Cross-Over Study. Nutrients. 2019 Apr 19;11(4):886. doi: 10.3390/nu11040886.
- Background: PubMed 31960952Bonfrate L, Di Palo DM, Celano G, Albert A, Vitellio P, De Angelis M, Gobbetti M, Portincasa P. Effects of Bifidobacterium longum BB536 and Lactobacillus rhamnosus HN001 in IBS patients. Eur J Clin Invest. 2020 Mar;50(3):e13201. doi: 10.1111/eci.13201. Epub 2020 Feb 12.
- Background: PubMed 31564245Portincasa P, De Angelis M, Lammert F, Stokes CS. Medicinal Diets: From Molecules to Nutrients to Foods: Basic and Clinical Implications. Curr Med Chem. 2019;26(19):3372-3375. doi: 10.2174/092986732619190821150547.
- Background: PubMed 35163038Portincasa P, Bonfrate L, Vacca M, De Angelis M, Farella I, Lanza E, Khalil M, Wang DQ, Sperandio M, Di Ciaula A. Gut Microbiota and Short Chain Fatty Acids: Implications in Glucose Homeostasis. Int J Mol Sci. 2022 Jan 20;23(3):1105. doi: 10.3390/ijms23031105.
- Individual participant dataSharing planned: No
Related trials for Microbiota
Active, not recruitingObservational study
Antibiotic Resistance Genes in Periodontitis
Periodontal Disease, Periodontitis
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Not yet recruitingObservational study
Non-Invasive Biomarker Monitoring in UC on Biologics
Ulcerative Colitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuperFood in people with Microbiota and Overweight and Obesity, run by University of Bari at 1 site in Italy.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jul 2022. 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 Italy. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of SuperFood on gut Microbiota and metabolome (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05451992, which also lists 6 linked publications.
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 11 Jul 2022.