Childhood ObesityPhase 4DAMOCLENCT04151758

Effect of Docosahexaenoic Acid Supplementation on Microbiome in Obese ChiLdrEn.

A Phase 4 study testing Docosahexaenoic Acid Supplementation, Promotion of physical activity and Promotion of healthy food habits in people with Childhood Obesity, run by University of Milan at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Evaluation of the possible effect of DHA supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. Read more about this study

Who is it for?: Ages 6 to 14 years
Conditions the study is for: Childhood Obesity
What is being tested?: Docosahexaenoic Acid Supplementation, Promotion of physical activity and Promotion of healthy food habits
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteItaly
Study dates: 7 Jan 2019to 30 May 2021
Phase: Phase 4
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 6 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

6 <Age <14 years
Severe obesity (>3 DS) according to WHO classification.
Gestational age: 37-42 weeks.
Birth-weight: > 2500 g e < 4000 g
Caucasian

Who cannot join

secondary obesity
supplementation with pre/probiotics (in the previous 3 months);
antibiotic treatment (in the previous 3 months);
chronic or acute intestinal diseases (in the previous 3 months).

Trial locations and contacts

1 site in 1 country.

Elvira Verduci, PhD contact

+39 3934771218

elvira.verduci@unimi.it

Italy1 site, 1 recruiting

Ospedale San Paolo
Milan, 20142
Elvira Verduci, MD PhD Assistant Professor, +39 0281844508, elvira.verduci@unimi.it
Recruiting

Other trials in Italy

About this study

Official title: Effect of Docosahexaenoic Acid Supplementation on Microbiome in Obese ChiLdrEn. The DAMOCLE Study

Evaluation of the possible effect of DHA supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production.

Read the detailed description

Differences in gut microbiota composition and function will be evaluated in obese children before starting the DHA supplementation and dietary-lifestyle intervention, at the end of DHA supplementation (4 months) e after 4 months of dietary dietary-lifestyle intervention without DHA supplementation. The investigators will identify the role of DHA on the intestinal microbiota and indicative species related to insulin resistance (IR). The investigators will determine whether DHA supplementation, combined with interventions to improve diet and lifestyle, reduces adverse metabolic consequences together with their co-morbidities.

The following tasks will be also performed at t0, t1 and t2:

Clinical examination including: physical examination, Tanner score evaluation; Bristol Stool Chart Blood pressure will be checked in all children by using oscillometric devices validated in the pediatric age group.

Anthropometry including body circumferences and skinfolds, calculation of BMI z scores and body composition. Body composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA).

Dietary assessment:

Food intakes will be recorded by prospective 3-d weighed food records obtained with food scales. Parents will be advised on how to record all food and beverages consumed during 2 weekdays and 1 weekend day. Quantification and analysis of the energy intake and nutrient composition will be performed with an ad hoc PC software (MètaDieta®, Me.Te.Da S.r.l., San Benedetto del Tronto, Italy).
Mediterranean Diet Quality Index (KIDMED) questionnaire for Mediterranean Diet assessment. The KIDMED index ranges from 0 to 12, and is based on a 16-question test that can be self-administered. The sums of the values from the administered test will be classified into three levels: 8 or more: optimal Mediterranean diet; 4-7: improvement needed to adjust intake to Mediterranean patterns. 3 or less: very low diet quality.

Hematological and biochemical status including:

Complete cell blood count;

Metabolic and nutritional parameters according to local routines for childhood obesity (fasting glucose, fasting insulin, LDL, HDL, total cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B levels, transaminases and amma-glutamyl transferase). Oral Glucose Tolerance Test (OGTT) will be performed. The insulin sensitivity and insulin resistance was assessed by calculating HOMA index (Homeostasis Model Assessment) and QUICKI (Quantitative Insulin-Sensitivity Check Index), using the following formulas:

HOMA: fasting plasma insulin in mU/l x FPG in mmol/l/22.5 QUICKI: 1/(log10 fasting plasma insulin in mU/l + log10 glucose in mg/dl)

Inflammatory index (VES, high-sensitive CRP, including fecal calprotectin)

Liver ultrasonography for detection of fatty liver disease

Conditions: Childhood Obesity
Being tested: Docosahexaenoic Acid Supplementation, Promotion of physical activity, Promotion of healthy food habits
Keywords: Childhood obesity, Gut microbiota, Nutrition, PUFA supplementation
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Docosahexaenoic Acid SupplementationDrug
Also called Lifestyle intervention, Diet intervention
Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day (2 ml per day DHA RICH OIL 25% aroma mandorla FoodAR Limbiate, Italy;50% DHA oil obtained from Schyzochitrium sp ; Martek Biosciences Corporation, Columbia, Maryland, USA) to all participants of the study. DHA 2 ml will provide about 16 kcal of energy.
Promotion of physical activityOther
All participants will underwent a visit at t0, t1 and t2 in which physical activity will be promoted according to Italian dietary guidelines for childhood obesity.
Promotion of healthy food habitsOther
All participants will underwent a visit at t0, t1 and t2 in which healthy food habits will be promoted according to Italian dietary guidelines for childhood obesity.

Study groups in NCT04151758
Study group	Role	What they receive
Docosahexaenoic Acid Supplementation, lifestyle intervention	Experimental	Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day. Physical activity and healthy eating habits will be encouraged. Receives: Drug: Docosahexaenoic Acid Supplementation; Other: Promotion of physical activity; Other: Promotion of healthy food habits

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in gut microbiota composition.
Interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. Differences in gut microbiota composition and function will be evaluated in obese children's stools before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). Study of the microbiota biodiversity will be performed by high-throughput sequencing techniques (16S rRNA gene sequencing) in order to establish whether postbiotics could modulate the microbial composition in obese children
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in short-chain fatty acid production by gut microbiota
Interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. Differences in gut microbiota composition and function will be evaluated in obese children's stools before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). Analysis of short chain fatty acids concentration by gas-chromatography (GC-FID) will be performed in order to monitor the effect of postbiotics intake modulating microbial metabolite production
Measured: t0: 0 t1: +4 months t2: +8 months

Secondary outcomes (22)

Changes in total cholesterol levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in LDL cholesterol levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in HDL cholesterol levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in triglycerides levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in fasting glucose levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in fasting insulin levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in HOMA index (Homeostasis Model Assessment)
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in QUICKI (Quantitative Insulin-Sensitivity Check Index)
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in alanine aminotransferase (ALT) levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in aspartate aminotransferase (ALT) levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in gamma glutamyl transferase (GGT) levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in body mass index
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in waist circumference
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in triceps skinfold
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in systemic arterial blood pressure
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Complete cell blood count
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in C-reactive protein (CRP) levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in erythrocyte sedimentation rate (ESR)
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in fecal calprotectin levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Measured: t0: 0 t1: +4 months t2: +8 months
Changes in body mass composition
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). body mass composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA)
Measured: t0: 0 t1: +4 months t2: +8 months
Oral glucose tolerance test (OGTT) result
Fasting glucose and glucose levels after 2 hours from ingestion of a glucose-containing solution.
Measured: t0
Degree of fatty liver disease evaluated by echosonography of the liver
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). body mass composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA)
Measured: t0: 0 t1: +4 months t2: +8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 201930 May 2021

First posted5 Nov 2019
Study start7 Jan 2019
Primary completion30 May 2021 (estimated)
Study completion30 May 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Childhood ObesityStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04151758
Sponsor's protocol ID: 2015/ST/135-1
Acronym: DAMOCLE
Status last verified: Nov 2020
First submitted: 30 Oct 2019
Last updated: 3 Nov 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Elvira Verduci, PhD

+39 3934771218

elvira.verduci@unimi.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Childhood Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Docosahexaenoic Acid Supplementation on Microbiome in Obese ChiLdrEn. The DAMOCLE Study
ClinicalTrials.gov ID: NCT04151758
Acronym / sponsor ID: DAMOCLE / 2015/ST/135-1
Conditions: Childhood Obesity
Keywords: Childhood obesity, Gut microbiota, Nutrition, PUFA supplementation
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: University of MilanUniversity, hospital or other
Study start: 7 Jan 2019 (actual)
Primary completion: 30 May 2021 (estimated)
Study completion: 30 May 2021 (estimated)
First posted: 5 Nov 2019 (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.

Evaluation of the possible effect of DHA supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production.

Detailed description

The following tasks will be also performed at t0, t1 and t2:

Dietary assessment:

Food intakes will be recorded by prospective 3-d weighed food records obtained with food scales. Parents will be advised on how to record all food and beverages consumed during 2 weekdays and 1 weekend day. Quantification and analysis of the energy intake and nutrient composition will be performed with an ad hoc PC software (MètaDieta®, Me.Te.Da S.r.l., San Benedetto del Tronto, Italy).
Mediterranean Diet Quality Index (KIDMED) questionnaire for Mediterranean Diet assessment. The KIDMED index ranges from 0 to 12, and is based on a 16-question test that can be self-administered. The sums of the values from the administered test will be classified into three levels: 8 or more: optimal Mediterranean diet; 4-7: improvement needed to adjust intake to Mediterranean patterns. 3 or less: very low diet quality.

Hematological and biochemical status including:

Complete cell blood count;

HOMA: fasting plasma insulin in mU/l x FPG in mmol/l/22.5 QUICKI: 1/(log10 fasting plasma insulin in mU/l + log10 glucose in mg/dl)

Inflammatory index (VES, high-sensitive CRP, including fecal calprotectin)

Liver ultrasonography for detection of fatty liver disease

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Docosahexaenoic Acid Supplementation, lifestyle intervention	Experimental	Drug: Docosahexaenoic Acid Supplementation, Other: Promotion of physical activity, Other: Promotion of healthy food habitsDocosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day. Physical activity and healthy eating habits will be encouraged.

Who may qualify

Ages: 6 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

6 <Age <14 years
Severe obesity (>3 DS) according to WHO classification.
Gestational age: 37-42 weeks.
Birth-weight: > 2500 g e < 4000 g
Caucasian

Key exclusion criteria (4 listed)

secondary obesity
supplementation with pre/probiotics (in the previous 3 months);
antibiotic treatment (in the previous 3 months);
chronic or acute intestinal diseases (in the previous 3 months).

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
Docosahexaenoic Acid SupplementationAlso: Lifestyle intervention, Diet interventionDocosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day (2 ml per day DHA RICH OIL 25% aroma mandorla FoodAR Limbiate, Italy;50% DHA oil obtained from Schyzochitrium sp ; Martek Biosciences Corporation, Columbia, Maryland, USA) to all participants of the study. DHA 2 ml will provide about 16 kcal of energy.	Drug	Docosahexaenoic Acid Supplementation, lifestyle intervention
Promotion of physical activityAll participants will underwent a visit at t0, t1 and t2 in which physical activity will be promoted according to Italian dietary guidelines for childhood obesity.	Other	Docosahexaenoic Acid Supplementation, lifestyle intervention
Promotion of healthy food habitsAll participants will underwent a visit at t0, t1 and t2 in which healthy food habits will be promoted according to Italian dietary guidelines for childhood obesity.	Other	Docosahexaenoic Acid Supplementation, lifestyle intervention

Primary outcome

Changes in gut microbiota composition.
Time frame: t0: 0 t1: +4 months t2: +8 months
Interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. Differences in gut microbiota composition and function will be evaluated in obese children's stools before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). Study of the microbiota biodiversity will be performed by high-throughput sequencing techniques (16S rRNA gene sequencing) in order to establish whether postbiotics could modulate the microbial composition in obese children
Changes in short-chain fatty acid production by gut microbiota
Time frame: t0: 0 t1: +4 months t2: +8 months
Interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. Differences in gut microbiota composition and function will be evaluated in obese children's stools before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). Analysis of short chain fatty acids concentration by gas-chromatography (GC-FID) will be performed in order to monitor the effect of postbiotics intake modulating microbial metabolite production

22 secondary outcomes

Changes in total cholesterol levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in LDL cholesterol levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in HDL cholesterol levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in triglycerides levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in fasting glucose levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in fasting insulin levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in HOMA index (Homeostasis Model Assessment)
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in QUICKI (Quantitative Insulin-Sensitivity Check Index)
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in alanine aminotransferase (ALT) levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in aspartate aminotransferase (ALT) levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in gamma glutamyl transferase (GGT) levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in body mass index
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in waist circumference
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in triceps skinfold
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in systemic arterial blood pressure
Time frame: t0: 0 t1: +4 months t2: +8 months
Complete cell blood count
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in C-reactive protein (CRP) levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in erythrocyte sedimentation rate (ESR)
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in fecal calprotectin levels
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in body mass composition
Time frame: t0: 0 t1: +4 months t2: +8 months
Oral glucose tolerance test (OGTT) result
Time frame: t0
Degree of fatty liver disease evaluated by echosonography of the liver
Time frame: t0: 0 t1: +4 months t2: +8 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
Individual participant dataSharing planned: No

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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.

Elvira Verduci, PhD contact

+39 3934771218

elvira.verduci@unimi.it

Elvira Verduci study chair

Hospital San Paolo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 3 Nov 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Elvira Verduci, PhD (+39 3934771218, elvira.verduci@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in gut microbiota composition. (time frame: t0: 0 t1: +4 months t2: +8 months). 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?

On the ClinicalTrials.gov record for NCT04151758.

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 3 Nov 2020.