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

Primary Purpose

Obesity, Appetitive Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SURG
DIET
HAES
Sponsored by
University of Eastern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring obesity, appetite, food reward, hormonal responses, psychophysiological responses, implicit measures, explicit measures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    SURG

    DIET

    HAES

    Arm Description

    subjects attending bariatric surgery

    subjects attending dietary weight loss program

    subjects attending Health At Every Size weight management program

    Outcomes

    Primary Outcome Measures

    Implicit associations
    D-score of Implicit Association Test
    Explicit ratings
    Ratings on visual analogue scales for wanting and liking of presented foods

    Secondary Outcome Measures

    Event-related potentials
    Event-related potentials measured by EEG
    Glucose
    Plasma glucose, fasting, postprandial
    Insulin
    plasma insulin, fasting, postprandial
    Ghrelin
    plasma ghrelin, fasting, postprandial
    Leptin
    serum leptin, fasting
    Peptide YY
    plasma peptide YY, fasting, postprandial
    Endocannabinoids
    plasma endocannabinoids, fasting, postprandial
    Weight
    body weight, fasting
    Eating behaviour
    self-reported questionnaires
    Psychosocial characteristics
    self-reported questionnaires

    Full Information

    First Posted
    December 19, 2016
    Last Updated
    November 1, 2019
    Sponsor
    University of Eastern Finland
    Collaborators
    VTT Technical Research Centre of Finland, Kuopio University Hospital, Alfido Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03550339
    Brief Title
    Regulation of Energy Balance and Metabolism - Mechanisms Behind and Beyond Obesity and Weight Loss
    Acronym
    BALANCE
    Official Title
    Regulation of Energy Balance and Metabolism - Mechanisms Behind and Beyond Obesity and Weight Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    April 2019 (Actual)
    Study Completion Date
    April 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Eastern Finland
    Collaborators
    VTT Technical Research Centre of Finland, Kuopio University Hospital, Alfido Ltd

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Appetitive Behavior
    Keywords
    obesity, appetite, food reward, hormonal responses, psychophysiological responses, implicit measures, explicit measures

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SURG
    Arm Type
    Active Comparator
    Arm Description
    subjects attending bariatric surgery
    Arm Title
    DIET
    Arm Type
    Active Comparator
    Arm Description
    subjects attending dietary weight loss program
    Arm Title
    HAES
    Arm Type
    Active Comparator
    Arm Description
    subjects attending Health At Every Size weight management program
    Intervention Type
    Procedure
    Intervention Name(s)
    SURG
    Intervention Description
    bariatric surgery according to Finnish Current Care Guidelines for Obesity in adults
    Intervention Type
    Behavioral
    Intervention Name(s)
    DIET
    Intervention Description
    dietary weight loss program according to Finnish Current Care Guidelines for Obesity in adults
    Intervention Type
    Behavioral
    Intervention Name(s)
    HAES
    Intervention Description
    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 Outcome Measure Information:
    Title
    Implicit associations
    Description
    D-score of Implicit Association Test
    Time Frame
    Change from baseline D-score at 1 year
    Title
    Explicit ratings
    Description
    Ratings on visual analogue scales for wanting and liking of presented foods
    Time Frame
    Change from baseline visual analogue scale at 1 year
    Secondary Outcome Measure Information:
    Title
    Event-related potentials
    Description
    Event-related potentials measured by EEG
    Time Frame
    Change from baseline event-related potentials at 1 year
    Title
    Glucose
    Description
    Plasma glucose, fasting, postprandial
    Time Frame
    Change from baseline glucose at 1 year
    Title
    Insulin
    Description
    plasma insulin, fasting, postprandial
    Time Frame
    Change from baseline insulin at 1 year
    Title
    Ghrelin
    Description
    plasma ghrelin, fasting, postprandial
    Time Frame
    Change from baseline ghrelin at 1 year
    Title
    Leptin
    Description
    serum leptin, fasting
    Time Frame
    Change from baseline leptin at 1 year
    Title
    Peptide YY
    Description
    plasma peptide YY, fasting, postprandial
    Time Frame
    Change from baseline PYY at 1 year
    Title
    Endocannabinoids
    Description
    plasma endocannabinoids, fasting, postprandial
    Time Frame
    Change from baseline endocannabinoids at 1 year
    Title
    Weight
    Description
    body weight, fasting
    Time Frame
    Change from baseline weight at 1 year
    Title
    Eating behaviour
    Description
    self-reported questionnaires
    Time Frame
    Change from baseline eating behaviour at 1 year
    Title
    Psychosocial characteristics
    Description
    self-reported questionnaires
    Time Frame
    Change from baseline psychosocial characteristics at 1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leila J Karhunen, PhD
    Organizational Affiliation
    University of Eastern Finland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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