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Weight-loss and Gut-brain Interactions

NCT01740050 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-12-04

No results posted yet for this study

Summary

While exposure to an obesogenic environment has increased for almost every individual in western society, not everyone is equally susceptible to overeating and not everyone becomes obese. Teasing apart the physiological underpinnings of those individual seemingly protective- differences may contribute to the development of successful preventive measures and treatment. Neuroimaging studies started to deliver important insights into the neuroanatomical determination of individual eating behavior. However, food intake is not only determined by the brain, but is orchestrated by an interaction of peripheral hormones with neural circuits and decision-making processes. This interactive axis is also referred to as the gut-brain axis. While individual aspects of the axis have been studied extensively, detailed insight in the interaction of gut and brain in the regulation of food intake is lacking.

Objective: The current study aims to investigate the effect of a) caloric restriction (very low calorie diet (VLCD)); b) caloric restriction with mechanical restriction (Laparoscopic adjustable gastric banding (LAGB)); and c) caloric restriction with mechanical restriction and physiological changes through malapsorption (Roux- en- Y bypass (RYGB) surgery) on gut-brain interactions to find an optimal balance for weight loss and long-term sustained weight maintenance.

Conditions

Interventions

DIETARY_SUPPLEMENT

Very Low Calorie Diet (VLCD)

One subject group will lose 10% of initial body weight using a VLCD. There are no risks for the subjects in consuming the VLCD (Modifast, together with the recommended fruit and vegetables) as the macronutrient composition and vitamins/minerals content meet the Dutch recommended daily allowance.

PROCEDURE

RYGB

PROCEDURE

LAGB

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Tanja C Adam, PhD · Maastricht University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-01-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01740050 on ClinicalTrials.gov