Very Low Calorie Diet Weight Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Understanding how foods and nutrients are digested, absorbed and metabolized when weight is stable and during weight loss induced by very low calorie diet procedure using the technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics ("omics") will enable generation of new hypotheses that could explain the inter-individual differences in weight loss and could lead to optimization and individualization of therapies designed to lose weight.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Plasma, Urine and Tear Omics Changes in Different Diets

NCT04984642

Diet, Healthy

COMPLETED NA

Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids

NCT02081898

Overweight Obese

COMPLETED PHASE3

Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults

NCT01497106

Insulin Resistance

COMPLETED NA

The Effect of Very Low Calorie Diet With and Without Exercise on Muscle Synthesis in Middle-aged Overweight Male.

NCT03116256

Overweight and Obesity

UNKNOWN NA

Caloric Restriction and Body Weight in Adults

NCT00808275

Overweight

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The overarching hypothesis is that there are baseline, pre- and post-diet combinations of 'omics' signatures in response to food and nutrients that explain the weight loss response of obese subjects to the very low calorie (VLC) diet.

In order to address the general hypothesis the following specific aims will be addressed:

Specific Aim 1: To test the hypothesis that there is a combination of 'omics' parameters in response to a defined meal that discriminate between morbidly obese subjects.

Specific Aim 2: To test the hypothesis that variation in % weight loss to the 2-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.

Specific Aim 3: To test the hypothesis that variation in % weight loss to the 4-weeks of VLC diet is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Very Low Calorie Diet

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

obese

screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical and psychological information about them that will help determine study eligibility or can be used for later coding.

3 study days (one baseline, one approx 2 weeks of diet, one post-diet): muscle mass and function tests, resting energy expenditure, stable isotope infusions with blood draws, and questionnaires regarding quality of life, mood and depression, diet.

Group Type EXPERIMENTAL

Stable isotope amino acid infusion

Intervention Type OTHER

such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stable isotope amino acid infusion

such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

· (Possible) pregnancy Any other condition according to the PI or nurse that would interfere with the study or safety of the patient Failure to give informed consent Use of protein or amino acid containing nutritional supplements within 3 days of first test day

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No