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

• ClinicalTrials.gov Identifier: NCT03550339
• Recruitment Status: Completed
• First Posted: June 8, 2018
• Last Update Posted: November 5, 2019
• Sponsor: University of Eastern Finland
• Collaborators: VTT Technical Research Centre of Finland; Kuopio University Hospital; Alfido Ltd
• Information provided by (Responsible Party): University of Eastern Finland

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Appetitive Behavior	Procedure: SURG; Behavioral: DIET; Behavioral: HAES	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Regulation of Energy Balance and Metabolism - Mechanisms Behind and Beyond Obesity and Weight Loss
• Actual Study Start Date: November 2016
• Actual Primary Completion Date: April 2019
• Actual Study Completion Date: April 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: SURG; subjects attending bariatric surgery	Procedure: SURG; bariatric surgery according to Finnish Current Care Guidelines for Obesity in adults
Active Comparator: DIET; subjects attending dietary weight loss program	Behavioral: DIET; dietary weight loss program according to Finnish Current Care Guidelines for Obesity in adults
Active Comparator: HAES; subjects attending Health At Every Size weight management program	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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Sponsors and Collaborators

University of Eastern Finland

VTT Technical Research Centre of Finland

Kuopio University Hospital

Alfido Ltd

Investigators

• Principal Investigator: Leila J Karhunen, PhD; University of Eastern Finland

More Information

• Responsible Party: University of Eastern Finland
• ClinicalTrials.gov Identifier: NCT03550339
• Other Study ID Numbers: 327/2016
• First Posted: June 8, 2018
• Last Update Posted: November 5, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of Eastern Finland:

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

Additional relevant MeSH terms:

Obesity; Weight Loss; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes