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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03550339
Acronym
BALANCE
Enrollment
50
Registered
2018-06-08
Start date
2016-11-30
Completion date
2019-04-30
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appetitive Behavior, Obesity

Keywords

obesity, appetite, food reward, hormonal responses, psychophysiological responses, implicit measures, explicit measures

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURESURG

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

BEHAVIORALDIET

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

BEHAVIORALHAES

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

Sponsors

VTT Technical Research Centre of Finland
CollaboratorOTHER
Kuopio University Hospital
CollaboratorOTHER
Alfido Ltd
CollaboratorUNKNOWN
University of Eastern Finland
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Implicit associationsChange from baseline D-score at 1 yearD-score of Implicit Association Test
Explicit ratingsChange from baseline visual analogue scale at 1 yearRatings on visual analogue scales for wanting and liking of presented foods

Secondary

MeasureTime frameDescription
InsulinChange from baseline insulin at 1 yearplasma insulin, fasting, postprandial
GhrelinChange from baseline ghrelin at 1 yearplasma ghrelin, fasting, postprandial
LeptinChange from baseline leptin at 1 yearserum leptin, fasting
Peptide YYChange from baseline PYY at 1 yearplasma peptide YY, fasting, postprandial
Event-related potentialsChange from baseline event-related potentials at 1 yearEvent-related potentials measured by EEG
WeightChange from baseline weight at 1 yearbody weight, fasting
Eating behaviourChange from baseline eating behaviour at 1 yearself-reported questionnaires
Psychosocial characteristicsChange from baseline psychosocial characteristics at 1 yearself-reported questionnaires
EndocannabinoidsChange from baseline endocannabinoids at 1 yearplasma endocannabinoids, fasting, postprandial
GlucoseChange from baseline glucose at 1 yearPlasma glucose, fasting, postprandial

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026