ObesityTREVNCT06395246
Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs
A study testing Active Comparator: Continuous calorie restriction and eTRE in people with Obesity, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial summary
The main aim of the present study is to evaluate the effectiveness of two dietary protocols: Daily Caloric Restriction (DCR) and Early Time-Restricted Feeding + DCR (eTRE) on metabolic homeostasis and the influence of circulating extracellular vesicles (EVs) as inter-organ communication elements in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Active Comparator: Continuous calorie restriction and eTRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2024to 20 Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 70 years old.
- BMI ranges between 27 and 40 kg/ m2.
- Absence of underlying pathology in medical and physical examination, except for those related to excess weight.
- Signature of the informed consent for participation in the study.
Who cannot join
- Serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease.
- Systemic diseases with intrinsic inflammatory activity (autoimmune diseases such as rheumatoid arthritis and asthma).
- Pregnancy and lactation.
- Vegetarians or subjects subjected to an irregular diet.
- Patients with severe eating disorders.
- Patients with clinical symptoms and signs of infection in the previous month.
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- Patients with chronic anti-inflammatory steroid treatments and/or nonsteroidal anti-inflammatory drugs.
- Recent antibiotic treatment.
- Uncontrolled alcoholism or drug abuse.
- Rotating or nocturnal shift workers.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Tarragona Juan XXIII
Tarragona, Tarragona, 43005
Juan Jose Vendrell Ortega, PhD, MD, Professor, +34 977295800, jvortega2002@gmail.com
About this study
Official title: The Usefulness of Circulating Microvesicles (host and Bacterial) in Regulating Metabolic Homeostasis in Obesity Randomized Study of Parallel Arms in Obese Patients Undergoing Caloric Restriction Diet Vs. Early Time-restricted Eating
The main aim of the present study is to evaluate the effectiveness of two dietary protocols: Daily Caloric Restriction (DCR) and Early Time-Restricted Feeding + DCR (eTRE) on metabolic homeostasis and the influence of circulating extracellular vesicles (EVs) as inter-organ communication elements in obese patients.
Read the detailed description
The specific objectives are:
- To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects.
- Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones.
- Define the "digital footprint" of EVs as inter-organ communication elements influencing metabolic status in obese subjects.
The study design comprises a randomized parallel-arm design (n=40) with consecutive 1:1 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction (DCR) (n=20) or an eTRE protocol (n=20) for 12 weeks. Clinical and analytical variables, adherence, satiety, chronotype, and brown fat content will be determined before and at the end of the follow-up. Derivatives of intestinal microbiota, short-chain fatty acids, bile acids, and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics. Glucagon-like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP) dynamics after a standard meal test. Metagenomics. Bioenergetic analysis of PBMC by SeaHorse. Total EV miRNA profile. Isolation of host and bacterial EVs. Characterization of the protein cargo of host and bacterial EVs.
- Conditions
- Obesity
- Being tested
- Active Comparator: Continuous calorie restriction, eTRE
- Keywords
- obesity, extracellular vesicles, incretins, bile acids, short-chain fatty acids, time-restricted feeding, caloric restriction, brown fat
- Medical subject headings
- Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Continuous calorie restrictionBehavioural
Individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention
eTREBehavioural
early (morning) time-restricted eating pluss individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention
| Study group | Role | What they receive |
|---|---|---|
| Continuous caloric restriction | Active comparator | Continuous calorie restriction diet based on healthy Mediterranean diet recommendations Receives: Behavioral: Active Comparator: Continuous calorie restriction |
| eTRE | Experimental | early (morning) time-restricted eating (eTRE) plus continuous caloric restriction diet based on healthy Mediterranean diet recommendations Receives: Behavioral: eTRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements (I)
Changes in weight (kg)
Measured: Before and after (12 weeks) of the intervention
Anthropometric measurements (II)
Changes in body mass index (kg/m^2);
Measured: Before and after (12 weeks) of the intervention
Anthropometric measurements (III)
Changes waist circumference (cm)
Measured: Before and after (12 weeks) of the intervention
Anthropometric measurements (IV)
Changes hip circumference (cm)
Measured: Before and after (12 weeks) of the intervention
Anthropometric measurements (V)
Changes neck circumference (cm)
Measured: Before and after (12 weeks) of the intervention
Body composition (I)
Changes in fat body mass (kg); assesed by bioimpedance monitoring device (Seca®)
Measured: Before and after (12 weeks) of the intervention
Body composition (II)
Changes in lean body mass (kg); assesed by bioimpedance monitoring device (Seca®)
Measured: Before and after (12 weeks) of the intervention
Body composition (III)
Changes visceral adipose tissue (L); assesed by bioimpedance monitoring device (Seca®)
Measured: Before and after (12 weeks) of the intervention
Brown fat
Changes in brown fat volume (cm3); assessed by magnetic resonance image (MRI)
Measured: Before and after (12 weeks) of the intervention
Secondary outcomes (9)
Gut and host microbiota-derived metabolites (I)
Changes in circulating short-chain fatty acids levels [µM]; assesed by Gas Chromatography-Tandem Mass Spectrometry (GC-MS/MS)
Measured: Before and after (12 weeks) of the intervention
Gut and host microbiota-derived metabolites (II)
Changes in circulating bile acids levels [nM]; Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Measured: Before and after (12 weeks) of the intervention
Gut and host microbiota-derived metabolites (III)
Changes in circulating succinate levels [µM]; assesed by EnzyChrom™ Succinate Assay Kit
Measured: Before and after (12 weeks) of the intervention
Entero-endocrine incretin hormones (I)
Changes in post-prandial response to a meal-tolerance test in serum levels of glucose [mg/dL]; assesed by ELISA kit
Measured: Before and after (12 weeks) of the intervention
Entero-endocrine incretin hormones (II)
Changes in post-prandial response to a meal-tolerance test in serum levels of insulin levels [pmol/L] ]assesed by ELISA kit
Measured: Before and after (12 weeks) of the intervention
Entero-endocrine incretin hormones (III)
Changes in post-prandial response to a meal-tolerance test in plasma levels of glucagon-like peptite 1 [GLP-1 ] (pmol/L); assesed by ELISA kit
Measured: Before and after (12 weeks) of the intervention
Entero-endocrine incretin hormones (IV)
Changes in post-prandial response to a meal-tolerance test in plasma levels of gastric inhibitory polypeptide (GIP) [pg/mL]; assesed by ELISA kit
Measured: Before and after (12 weeks) of the intervention
Microbial composition/metagenomic
Changes in alpha and beta diversity, relative abundance and functional metagenomics; assesed by Ilumina metagenomics
Measured: Before and after (12 weeks) of the intervention
Cellular energy metabolism
Changes in Cluster of Differentiation 14 positive (CD14+) monocytes isolated from peripheral blood mononuclear cells (PBMCs) will be used for bioenergetics analysis via an extracellular flux analyzer
Measured: Before and after (12 weeks) of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start20 May 2024
- Primary completion30 May 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel-arm design (n=40) with consecutive 1:1 allocation to either a continuous calorie restriction diet (n=20) for a healthy Mediterranean diet or an early time-restricted eating protocol + continuous caloric restriction (n=20) over 12 weeks.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan José Vendrell Ortega, Professor, Principal investigator, Instituto de Investigación Sanitaria Pere Virgili (IISPV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395246
- Sponsor's protocol ID
- PI23/01133
- Acronym
- TREV
- Status last verified
- Oct 2024
- First submitted
- 24 Apr 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Circulating Microvesicles (host and Bacterial) in Regulating Metabolic Homeostasis in Obesity Randomized Study of Parallel Arms in Obese Patients Undergoing Caloric Restriction Diet Vs. Early Time-restricted Eating
- ClinicalTrials.gov ID
- NCT06395246
- Acronym / sponsor ID
- TREV / PI23/01133
- Conditions
- Obesity
- Keywords
- obesity, extracellular vesicles, incretins, bile acids, short-chain fatty acids, time-restricted feeding, caloric restriction, brown fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 2 May 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.
The main aim of the present study is to evaluate the effectiveness of two dietary protocols: Daily Caloric Restriction (DCR) and Early Time-Restricted Feeding + DCR (eTRE) on metabolic homeostasis and the influence of circulating extracellular vesicles (EVs) as inter-organ communication elements in obese patients.
Detailed description
The specific objectives are:
- To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects.
- Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones.
- Define the "digital footprint" of EVs as inter-organ communication elements influencing metabolic status in obese subjects.
The study design comprises a randomized parallel-arm design (n=40) with consecutive 1:1 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction (DCR) (n=20) or an eTRE protocol (n=20) for 12 weeks. Clinical and analytical variables, adherence, satiety, chronotype, and brown fat content will be determined before and at the end of the follow-up. Derivatives of intestinal microbiota, short-chain fatty acids, bile acids, and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics. Glucagon-like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP) dynamics after a standard meal test. Metagenomics. Bioenergetic analysis of PBMC by SeaHorse. Total EV miRNA profile. Isolation of host and bacterial EVs. Characterization of the protein cargo of host and bacterial EVs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel-arm design (n=40) with consecutive 1:1 allocation to either a continuous calorie restriction diet (n=20) for a healthy Mediterranean diet or an early time-restricted eating protocol + continuous caloric restriction (n=20) over 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Continuous caloric restriction | Active comparator | Behavioral: Active Comparator: Continuous calorie restrictionContinuous calorie restriction diet based on healthy Mediterranean diet recommendations |
| eTRE | Experimental | Behavioral: eTREearly (morning) time-restricted eating (eTRE) plus continuous caloric restriction diet based on healthy Mediterranean diet recommendations |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 70 years old.
- BMI ranges between 27 and 40 kg/ m2.
- Absence of underlying pathology in medical and physical examination, except for those related to excess weight.
- Signature of the informed consent for participation in the study.
Key exclusion criteria (10 listed)
- Serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease.
- Systemic diseases with intrinsic inflammatory activity (autoimmune diseases such as rheumatoid arthritis and asthma).
- Pregnancy and lactation.
- Vegetarians or subjects subjected to an irregular diet.
- Patients with severe eating disorders.
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 |
|---|---|---|
| Active Comparator: Continuous calorie restrictionIndividualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention | Behavioural | Continuous caloric restriction |
| eTREearly (morning) time-restricted eating pluss individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention | Behavioural | eTRE |
Primary outcome
Anthropometric measurements (I)
Time frame: Before and after (12 weeks) of the intervention
Changes in weight (kg)
Anthropometric measurements (II)
Time frame: Before and after (12 weeks) of the intervention
Changes in body mass index (kg/m^2);
Anthropometric measurements (III)
Time frame: Before and after (12 weeks) of the intervention
Changes waist circumference (cm)
Anthropometric measurements (IV)
Time frame: Before and after (12 weeks) of the intervention
Changes hip circumference (cm)
Anthropometric measurements (V)
Time frame: Before and after (12 weeks) of the intervention
Changes neck circumference (cm)
Body composition (I)
Time frame: Before and after (12 weeks) of the intervention
Changes in fat body mass (kg); assesed by bioimpedance monitoring device (Seca®)
Body composition (II)
Time frame: Before and after (12 weeks) of the intervention
Changes in lean body mass (kg); assesed by bioimpedance monitoring device (Seca®)
Body composition (III)
Time frame: Before and after (12 weeks) of the intervention
Changes visceral adipose tissue (L); assesed by bioimpedance monitoring device (Seca®)
Brown fat
Time frame: Before and after (12 weeks) of the intervention
Changes in brown fat volume (cm3); assessed by magnetic resonance image (MRI)
9 secondary outcomes
Gut and host microbiota-derived metabolites (I)
Time frame: Before and after (12 weeks) of the intervention
Gut and host microbiota-derived metabolites (II)
Time frame: Before and after (12 weeks) of the intervention
Gut and host microbiota-derived metabolites (III)
Time frame: Before and after (12 weeks) of the intervention
Entero-endocrine incretin hormones (I)
Time frame: Before and after (12 weeks) of the intervention
Entero-endocrine incretin hormones (II)
Time frame: Before and after (12 weeks) of the intervention
Entero-endocrine incretin hormones (III)
Time frame: Before and after (12 weeks) of the intervention
Entero-endocrine incretin hormones (IV)
Time frame: Before and after (12 weeks) of the intervention
Microbial composition/metagenomic
Time frame: Before and after (12 weeks) of the intervention
Cellular energy metabolism
Time frame: Before and after (12 weeks) of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- 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.
Juan José Vendrell Ortega, Professor principal investigator
Instituto de Investigación Sanitaria Pere Virgili (IISPV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Continuous calorie restriction and eTRE in people with Obesity, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
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 10 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 4 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 Spain. 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 Juan José Vendrell Ortega, Professor (+34 619672912, jvortega2002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurements (I) (time frame: Before and after (12 weeks) of the intervention). The study lists 9 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 4 Oct 2024.