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

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
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
NCT ID
NCT03550339
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
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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