Personalized or Precision Medicine in the Dietary Approach to Obesity

NCT05420311 | Unknown

• 1 other identifier: PI21/01677
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this project is to apply a precision medicine approach to try to explain the intra-individual variability of the response to different weight loss approaches: a balanced hypocaloric diet in macronutrients (MedDiet), a very low carbohydrate diet (KetoDiet) and an intermittent fasting (IF) approach, and try to establish in a personalized manner with the individual variability in genetics, metabolites, intestinal microbiome, and environmental factors the best dietary strategy for weight loss. As secondary objectives the investigators pretend to O1: To analyze whether individual variability in genetics, epigenetics, intestinal microbiome, and environmental factors determine the changes in insulin resistance, blood pressure, lipid levels and NASH markers after three different dietary interventions. O2: To analyze whether individual variability in genetics, epigenetics, intestinal microbiome, and environmental factors determine the changes in the body composition and the different ratio of free-fat/ fat mass loss after three different dietary interventions. O3: To determine the most effective intervention to increase the loss of fat mass, preserve the free-fat mass and trigger a better metabolic profile. O4: To follow-up changes in gut microbiota and DNA methylation after each of the cross-over dietary interventions. O5: To evaluate the transcriptional response of adipose tissue and elucidate its predictive value for the body-composition changes in patients subjected to the different dietary interventions. O6: To evaluate the influence of D-ß-hydroxybutyrate as well as other short-chain acyl-CoA precursor metabolites in human adipocytes lipolysis by in vitro experimentation and elucidate the influence of metabolite-sensitive histone modifications in the shaping of adipose transcriptional program and lipolysis sensitivity. O7: To develop a machine learning algorithm based on genetics, epigenetics, intestinal microbiome, and environmental factors for the prediction of the best dietary approach for weight loss in a personalized manner. To try to respond to these objectives, the investigators will apply two models: a randomized cross-over study testing three different dietary weight-loss interventions: MedDiet, KetoDiet, and IF with wash-out periods before each intervention.

Conditions

Obesity

Keywords

Precision medicine, nutrigenomics, microbiome, obesity, diet

Outcome Measures

Primary Outcomes (1)

• Changes in body weight after each intervention

  Weight in kg

  From baseline to 1 month

Secondary Outcomes (13)

• Changes in body composition and in the ratio of free-fat / fat mass loss after the three different dietary interventions.

  From baseline to 1 month

• Changes in the degree of insulin resistance.

  From baseline to 1 month

• Changes in the systolic blood pressure

  From baseline to 1 month

• Changes in the diastolic blood pressure

  From baseline to 1 month

• Changes in lipid profile (triglycerides)

  From baseline to 1 month

Study Arms (3)

A balanced hypocaloric diet in macronutrients (MedDiet).

EXPERIMENTAL

Mediterranean diet based on olive oil as main fat and regular consumption of vegetables (2 daily rations), fruits (3 daily rations), legumes (3 weekly rations), fish (3 weekly rations), with low consumption of red meat and meat products (less than twice a week), dairy foods (less than once a week) and no sweets, pastries or sugary drinks. Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein distributed in at least 4 meals (breakfast, lunch, afternoon snack and dinner).

Other: MedDiet Arm

A very low carbohydrate diet (KetoDiet).

EXPERIMENTAL

Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein

Other: KetoDiet Arm

An intermittent fasting (IF) approach.

EXPERIMENTAL

In this diet subjects alternate norm caloric diet during 24 h (according to Harris-Benedict equation) and a diet including only 25% of caloric requirements the following 24 h (this day diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein).

Other: IF Arm

Interventions

MedDiet Arm OTHER

A balanced hypocaloric diet in macronutrients (MedDiet)

A balanced hypocaloric diet in macronutrients (MedDiet).

KetoDiet Arm OTHER

A very low carbohydrate diet (KetoDiet).

A very low carbohydrate diet (KetoDiet).

IF Arm OTHER

An intermittent fasting (IF) approach

An intermittent fasting (IF) approach.

Eligibility Criteria

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

You may qualify if:

• Participants aged ≥ 18 and \<70 years old who were derived to the obesity-management unit of the Endocrinology and Nutrition Unit of the Virgen de la Victoria Hospital (Málaga).
• BMI between 35 and 45 kg/m2.

You may not qualify if:

• Pregnant or lactating
• Following a prescribed diet for any reason in the past 3 months
• Celiac disease, Crohn's disease or any condition altering nutritional requirements.
• Allergies or food intolerances, as well as antibiotics treatment or usual probiotics intake.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Franscisco J. Tinahones, MD, PhD.

  Instituto de Investigacion Biomedica de Malaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Moreno Indias, PhD.

CONTACT

951032647; Isabel.moreno@ibima.eu

Franscisco J. Tinahones, MD, PhD.

CONTACT

951032647; fjtinahones@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized cross-over study testing three different dietary weight-loss interventions

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 15, 2022
• Study Start: October 31, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 26, 2022

Record last verified: 2022-04

Locations

ES (1)