Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

NCT06395246 | Recruiting

• 1 other identifier: PI23/01133
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

obesity; extracellular vesicles; incretins; bile acids; short-chain fatty acids; time-restricted feeding; caloric restriction; brown fat

Outcome Measures

Primary Outcomes (9)

• Anthropometric measurements (I)

  Changes in weight (kg)

  Before and after (12 weeks) of the intervention

• Anthropometric measurements (II)

  Changes in body mass index (kg/m\^2);

  Before and after (12 weeks) of the intervention

• Anthropometric measurements (III)

  Changes waist circumference (cm)

  Before and after (12 weeks) of the intervention

• Anthropometric measurements (IV)

  Changes hip circumference (cm)

  Before and after (12 weeks) of the intervention

• Anthropometric measurements (V)

  Changes neck circumference (cm)

  Before and after (12 weeks) of the intervention

• Body composition (I)

  Changes in fat body mass (kg); assesed by bioimpedance monitoring device (Seca®)

  Before and after (12 weeks) of the intervention

• Body composition (II)

  Changes in lean body mass (kg); assesed by bioimpedance monitoring device (Seca®)

  Before and after (12 weeks) of the intervention

• Body composition (III)

  Changes visceral adipose tissue (L); assesed by bioimpedance monitoring device (Seca®)

  Before and after (12 weeks) of the intervention

• Brown fat

  Changes in brown fat volume (cm3); assessed by magnetic resonance image (MRI)

  Before and after (12 weeks) of the intervention

Secondary Outcomes (9)

• Gut and host microbiota-derived metabolites (I)

  Before and after (12 weeks) of the intervention

• Gut and host microbiota-derived metabolites (II)

  Before and after (12 weeks) of the intervention

• Gut and host microbiota-derived metabolites (III)

  Before and after (12 weeks) of the intervention

• Entero-endocrine incretin hormones (I)

  Before and after (12 weeks) of the intervention

• Entero-endocrine incretin hormones (II)

  Before and after (12 weeks) of the intervention

Study Arms (2)

Continuous caloric restriction

ACTIVE COMPARATOR

Continuous calorie restriction diet based on healthy Mediterranean diet recommendations

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

Behavioral: eTRE

Interventions

Active Comparator: Continuous calorie restriction BEHAVIORAL

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

Continuous caloric restriction

eTRE BEHAVIORAL

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

eTRE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

Hospital Universitario de Tarragona Juan XXIII

Tarragona, Tarragona, 43005, Spain

RECRUITING

MeSH Terms

Conditions

Obesity; Intermittent Fasting

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Juan José Vendrell Ortega, Professor

  Instituto de Investigación Sanitaria Pere Virgili (IISPV)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan José Vendrell Ortega, Professor

CONTACT

+34 619672912; jvortega2002@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: triple-blind: participants, intervention researchers - except for the nutritionist in charge of diet and lifestyle counseling - and data analysts will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 2, 2024
• Study Start: May 20, 2024
• Primary Completion: May 30, 2025
• Study Completion: December 20, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)