Skip to main content
OpenTrials
Completed

NCT Number: NCT03550339

Regulation of Energy Balance and Metabolism - Mechanisms Behind and Beyond Obesity and Weight Loss

The study aims to investigate homeostatic and hedonic mechanisms regulating appetite, energy balance and metabolism in obesity and the effects of three distinct obesity treatments on these regulatory mechanisms.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Obesity is widely acknowledged health problem affecting millions of people globally. Enormous efforts have been made to solve the problem, but long-term results of the conventional weight loss and/or weight management strategies have been poor indicating still inadequate understanding of the problem. Surgical, rather than weight-centred lifestyle interventions, have proved to be the most effective tool available to treat obesity within individuals suitable for obesity surgery. Current surgical interventions are, however, suitable only for a small subset of obese individuals. In general, there is a need for development of new approaches and therapies that are safer and more individualized to each patient in the struggle against obesity and related disorders. To achieve these goals, research must focus to investigate and understand the complex homeostatic and hedonic regulation of eating behavior and energy balance in different physiological and pathological conditions.

This study aims to investigate homeostatic and hedonic mechanisms regulating energy balance and metabolism in obesity and the effects of three distinct obesity treatments on these regulatory mechanisms. The regulatory mechanisms are investigated at the level of metabolism, autonomic and central nervous systems as well as subjective, both implicit and explicit, experiences.

A total of 90 obese female volunteers (18-65 years, body mass index > 35 kg/m2), of which 30 females waiting for bariatric surgery (SURG), 30 females attending a dietary treatment program for obesity (DIET) and 30 females attending Health at Every Size (HAES) program, will participate in the study. The obesity treatment for SURG and DIET groups follows the principles of the Current Care Guidelines for Obesity (adults) and the treatment for the HAES group applies the strategies of the non-diet wellness-based HAES program. The treatment programs of the DIET and HAES groups include 8-10 weekly group sessions organized by authorised nutritionist.

The study includes also two four-hour visits at the research laboratory of the Institute of Public Health and Clinical Nutrition, University of Eastern Finland, the first visit organized before the participants attend any of the obesity treatments and the second visit 12 months later. During the laboratory visits psychophysiological signals (EEG, ANS, facial EMG and eye tracking) are monitored and blood samples taken throughout the experimental period. Participants will also perform two computer-based test sessions, the first one at baseline and the second before a snack meal. Two meals (breakfast and snack meal) are offered to the participants during the experiment in order to study the regulatory mechanisms of interest both at the homeostatic and hedonic states.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • body mass index >34 kg/m2
  • native finnish speaker
  • right-handed

Exclusion criteria

  • pregnancy or breast feeding
  • severe visual impairments, severe scalp skin lesions or intracranial bleeding during previous six months
  • severe neurological, psychiatric or cardiovascular disease
  • type 1 or 2 diabetes mellitus
  • use of weight loss medications or other treatments known to affect weight
  • heavy alcohol use
  • any other condition (medical or other) the principal investigator considers as an obstacle to participation

Treatment and study plan

SURG

Procedure

bariatric surgery according to Finnish Current Care Guidelines for Obesity in adults

Diet

Behavioral

dietary weight loss program according to Finnish Current Care Guidelines for Obesity in adults

HAES

Behavioral

treatment is based on the previously published procedure (e.g. Bacon et al. 2002) and Health At Every Size trademark, consisting of body acceptance, eating behaviour, physical activity, nutrition, and social support

Primary outcomes

  1. Implicit associations

    Time frame: Change from baseline D-score at 1 year

    D-score of Implicit Association Test

  2. Explicit ratings

    Time frame: Change from baseline visual analogue scale at 1 year

    Ratings on visual analogue scales for wanting and liking of presented foods

Secondary outcomes

  1. Event-related potentials

    Time frame: Change from baseline event-related potentials at 1 year

    Event-related potentials measured by EEG

  2. Glucose

    Time frame: Change from baseline glucose at 1 year

    Plasma glucose, fasting, postprandial

  3. Insulin

    Time frame: Change from baseline insulin at 1 year

    plasma insulin, fasting, postprandial

  4. Ghrelin

    Time frame: Change from baseline ghrelin at 1 year

    plasma ghrelin, fasting, postprandial

  5. Leptin

    Time frame: Change from baseline leptin at 1 year

    serum leptin, fasting

  6. Peptide YY

    Time frame: Change from baseline PYY at 1 year

    plasma peptide YY, fasting, postprandial

  7. Endocannabinoids

    Time frame: Change from baseline endocannabinoids at 1 year

    plasma endocannabinoids, fasting, postprandial

  8. Weight

    Time frame: Change from baseline weight at 1 year

    body weight, fasting

  9. Eating behaviour

    Time frame: Change from baseline eating behaviour at 1 year

    self-reported questionnaires

  10. Psychosocial characteristics

    Time frame: Change from baseline psychosocial characteristics at 1 year

    self-reported questionnaires

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Collaborators

  • Alfido Ltd
  • Kuopio University Hospital
  • VTT Technical Research Centre of Finland

Registry information

Acronym: BALANCE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2018
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.