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

NCT ID: NCT03550339

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-04-30

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.

Conditions

Obesity; Appetitive Behavior

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

SURG

subjects attending bariatric surgery

Group Type: ACTIVE_COMPARATOR

SURG

Intervention Type: PROCEDURE

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

DIET

subjects attending dietary weight loss program

Group Type: ACTIVE_COMPARATOR

DIET

Intervention Type: BEHAVIORAL

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

HAES

subjects attending Health At Every Size weight management program

Group Type: ACTIVE_COMPARATOR

HAES

Intervention Type: 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

Interventions

SURG

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

Intervention Type: PROCEDURE

DIET

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

Intervention Type: BEHAVIORAL

HAES

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

VTT Technical Research Centre of Finland

OTHER

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: collaborator

Alfido Ltd

UNKNOWN

Sponsor Role: collaborator

University of Eastern Finland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leila J Karhunen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Other Identifiers

327/2016

Identifier Type: -

Identifier Source: org_study_id