Glucose Metabolism DisordersNCT06247020
Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals
A study testing Supplementation with sodium- butyrrate in people with Glucose Metabolism Disorders and Overweight or Obesity, run by Federico II University at 1 site in Italy.
Trial summary
Numerous evidences suggest an important role of short-chain fatty acids, produced by the intestinal fermentation of dietary fibers by the intestinal microbiota, in the modulation of various biological functions relevant to human health. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Glucose Metabolism Disorders, Overweight or Obesity
- What is being tested?
- Supplementation with sodium- butyrrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 24 Feb 2022to 13 Jun 2023
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index: 25-30 kg/m2
Who cannot join
- type 2 diabetes,
- treatment with antibiotics within the past 3 months
- history of gastrointestinal diseases (Inflammatory bowel disease, Crohn's disease, malabsorption etc )
- cardiovascular events (myocardial infarction or stroke) during the 6-12 months prior to the study
- thyroid disorders not controlled by drug therapy,
- kidney (creatinine >1.7 mg/dl or proteinuria) and liver diseases (ALT/AST >twice the upper limits)
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- anaemia (Hb <12 g /dl)
- pregnancy or breastfeeding,
- celiac disease, cancer or any other chronic disease
Trial locations and contacts
1 site in 1 country.
Italy1 site
Federico II University, Department of Clinical Medicine and Surgery
Naples, 80131
About this study
Official title: Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals: a Pilot Study
Numerous evidences suggest an important role of short-chain fatty acids, produced by the intestinal fermentation of dietary fibers by the intestinal microbiota, in the modulation of various biological functions relevant to human health. In particular, butyrate, in addition to its trophic action on enterocytes, could improve insulin sensitivity and increase GLP-1 secretion, suggesting a possible role in the modulation of glucose metabolism. However, to date, very few randomized controlled trials (RCTs) have observed a significant increase in plasma butyrate concentrations in humans after nutritional interventions with high-fiber diets or foods. Butyrate occurs naturally in some foods, such as milk and dairy products, where it is often associated with sodium, becoming sodium butyrate. Therefore, recent studies suggest the use of oral sodium butyrate supplements in order to obtain a significant increase in butyrate plasma concentrations able to exert the potential beneficial effects related to them. To date, few studies have investigated the effect of oral sodium butyrate supplementation on glucose metabolism in healthy or overweight individuals, individuals at high cardiometabolic risk, and individuals with type 2 diabetes. Therefore, the purpose of this pilot study is to evaluate the effects of oral sodium butyrate supplementation, versus placebo, on glucose tolerance and insulin sensitivity in a group of overweight/obese individuals and the mechanisms underlying these effects.
- Being tested
- Supplementation with sodium- butyrrate, Placebo
- Keywords
- butyrate, sodium butyrate, short chain fatty acids, glucose, insulin
- Medical subject headings
- Glucose Metabolism Disorders, Overweight, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation with sodium- butyrrateDietary supplement
Oral supplementation with sodium butyrrate capsules
PlaceboDietary supplement
Oral supplementation with placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Oral sodium-butyrrate supplementation | Experimental | Participants consumed 8 capsules of sodium butyrate per day for a week. The capsules were consumed with main meals (2 for breakfast, 2 for lunch and 2 for dinner). Each capsule contained 200 mg of sodium butyrate, for a total of 1.6 grams of sodium butyrate per day. Receives: Dietary Supplement: Supplementation with sodium- butyrrate |
| Placebo | Placebo comparator | Participants consumed 8 capsules of placebo. The capsules were consumed with main meals (2 for breakfast, 2 for lunch and 2 for dinner). Each capsule contained cornstarch Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
The primary outcome of the study is the improvement of the glucose response during an oral glucose tolerance test (OGTT) after the supplementation with sodium butyrate, without changes in body weight
Measured: one week
Secondary outcomes (1)
Plasma insulin
The secondary outcome of the study is the improvement of the insulin response during an oral glucose tolerance test (OGTT) after the supplementation with sodium butyrate, without changes in body weightglycemic and insulinemic response during an OGTT separately in men and women
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start24 Feb 2022
- Primary completion15 Mar 2023
- Study completion13 Jun 2023
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.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rivellese angela, Federico II University
- Investigators
- Angela Albarosa Rivellese, PO, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247020
- Sponsor's protocol ID
- 368/19
- Status last verified
- Feb 2024
- First submitted
- 15 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals: a Pilot Study
- ClinicalTrials.gov ID
- NCT06247020
- Acronym / sponsor ID
- 368/19
- Keywords
- butyrate, sodium butyrate, short chain fatty acids, glucose, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 7 Feb 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.
Numerous evidences suggest an important role of short-chain fatty acids, produced by the intestinal fermentation of dietary fibers by the intestinal microbiota, in the modulation of various biological functions relevant to human health. In particular, butyrate, in addition to its trophic action on enterocytes, could improve insulin sensitivity and increase GLP-1 secretion, suggesting a possible role in the modulation of glucose metabolism. However, to date, very few randomized controlled trials (RCTs) have observed a significant increase in plasma butyrate concentrations in humans after nutritional interventions with high-fiber diets or foods. Butyrate occurs naturally in some foods, such as milk and dairy products, where it is often associated with sodium, becoming sodium butyrate. Therefore, recent studies suggest the use of oral sodium butyrate supplements in order to obtain a significant increase in butyrate plasma concentrations able to exert the potential beneficial effects related to them. To date, few studies have investigated the effect of oral sodium butyrate supplementation on glucose metabolism in healthy or overweight individuals, individuals at high cardiometabolic risk, and individuals with type 2 diabetes. Therefore, the purpose of this pilot study is to evaluate the effects of oral sodium butyrate supplementation, versus placebo, on glucose tolerance and insulin sensitivity in a group of overweight/obese individuals and the mechanisms underlying these effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral sodium-butyrrate supplementation | Experimental | Dietary Supplement: Supplementation with sodium- butyrrateParticipants consumed 8 capsules of sodium butyrate per day for a week. The capsules were consumed with main meals (2 for breakfast, 2 for lunch and 2 for dinner). Each capsule contained 200 mg of sodium butyrate, for a total of 1.6 grams of sodium butyrate per day. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants consumed 8 capsules of placebo. The capsules were consumed with main meals (2 for breakfast, 2 for lunch and 2 for dinner). Each capsule contained cornstarch |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body Mass Index: 25-30 kg/m2
Key exclusion criteria (9 listed)
- type 2 diabetes,
- treatment with antibiotics within the past 3 months
- history of gastrointestinal diseases (Inflammatory bowel disease, Crohn's disease, malabsorption etc )
- cardiovascular events (myocardial infarction or stroke) during the 6-12 months prior to the study
- thyroid disorders not controlled by drug therapy,
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 |
|---|---|---|
| Supplementation with sodium- butyrrateOral supplementation with sodium butyrrate capsules | Dietary supplement | Oral sodium-butyrrate supplementation |
| PlaceboOral supplementation with placebo capsules | Dietary supplement | Placebo |
Primary outcome
Plasma glucose
Time frame: one week
The primary outcome of the study is the improvement of the glucose response during an oral glucose tolerance test (OGTT) after the supplementation with sodium butyrate, without changes in body weight
1 secondary outcome
Plasma insulin
Time frame: one week
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 7 Feb 2024.
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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. This study is not recruiting at the moment.
Angela Albarosa Rivellese, PO principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementation with sodium- butyrrate in people with Glucose Metabolism Disorders and Overweight or Obesity, run by Federico II University 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 1 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: finished, as of the sponsor's last update on 7 Feb 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 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?
Plasma glucose (time frame: one week). 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 7 Feb 2024.