Plain English Summary
Background and study aims
Success in weight management is challenging. Even after successful weight loss, weight regain is very common. Therefore it is important to identify factors that affect self-regulation of food intake and other behaviors related to weight management. The study aims to find out such factors associated with weight management, especially whether the satiety value of food as a part of a weight-maintenance diet would affect self-regulation of food intake and weight management.
Who can participate?
Obese men and women, aged 30-65 years, will be recruited into the study.
What does the study involve?
The study consists of weight-loss and weight-maintenance periods. During the weight-loss period, all participants receive a very low calorie diet for 8 weeks. During the 24-week weight maintenance period, subjects are randomly allocated to two groups to consume as part of their weight-management diet foods with either higher or lower satiety values.
What are the possible benefits and risks of participating?
The possible and expected benefit of participating in the study is weight loss along with its well-known beneficial effects on health and wellbeing. The risk of participating in the study is the possible disappointment to the participant if the weight loss is not as great as they have expected or in the case of possible weight re-gain.
Where is the study run from?
Institute of Public Health and Clinical Nutrition, University of Kuopio (currently University of Eastern Finland), Kuopio, Finland.
When is study starting and how long is it expected to run for?
The study started in May 2008 and ended in February 2010.
Who is funding the study?
Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Finland.
Who is the main contact?
Dr Leila Karhunen
leila.karhunen@uef.fi
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
40100/07 (Tekes)
Study information
Scientific title
Foods for weight management: a randomized controlled trial
Acronym
ELIPA
Study hypothesis
It is hypothesized that foods with higher predetermined satiety values, when ingested as a part of a weight-maintenance diet, contribute to better self-regulation of food intake and reduced body weight.
Ethics approval
The Ethics Committee of the District Hospital Region of Northern Savo and the Kuopio University Hospital; Ref: 46/2008
Study design
Clinical randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obesity
Intervention
Participants are randomized to two groups: high-satiety and low-satiety food groups
All participants will receive a very low calorie diet for 8 weeks. The weight maintenance period is 24 weeks.
Follow-up visit at 8-9 months after the end of the weight maintenance period, about which the participants had not been informed beforehand. This visit was added afterwards into the original study plan.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Body weight measured by a digital scale at baseline, 8, 12, 24 weeks and at follow-up.
Secondary outcome measures
1. Anthropometry and body composition: height measured using a wall-mounted stadiometer at screening; waist circumference using a calibrated tape measured at baseline, 8, 12 and 24 weeks; body composition using fat mass and fat-free mass by bioelectrical impedance measured at baseline, 8, 12 and 24 weeks
2. Eating behaviour by questionnaires at baseline, 12 and 24 weeks
3. Glucose and lipid metabolism and satiety-related hormones measured at baseline, 8, 12 and 24 weeks
3.1. Lipid metabolism: fasting serum HDL-, LDL-, total cholesterol, triglycerides and free fatty acids samples
3.2. Glucose metabolism: fasting and 2-hour oral glucose tolerance test (time points 0 min, 30 min, 60 min and 120 min) plasma/serum glucose and insulin samples
3.3. Satiety-related hormones: fasting plasma ghrelin, leptin, peptide YY samples
4. Inflammatory markers: serum/plasma CRP, IL6, IL1ra, adiponectin samples measured at baseline, 8 and 24 weeks
5. Adipose tissue and peripheral blood mononuclear cell gene expression: optional, performed only for those who were willing to give the samples. Measured by adipose tissue biopsies from subcutaneous abdominal fat and peripheral blood mononuclear cells (PBMCs) isolated from anticoagulated peripheral blood samples measured at baseline, 8 and 24 weeks
6. Gut microbiota composition by taking fecal samples measured at baseline, 8 and 24 weeks
Overall trial start date
01/05/2008
Overall trial end date
28/02/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Body mass index 3040 kg/m2
2. Age 3065 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. BMI >40 or <30 kg/m2
2. Pregnancy
3. Type 1 or 2 diabetes, abnormal liver, thyroid or kidney function or polycystic ovary syndrome
4. Less than 6 months since coronary event or operation
5. Myocardial infarction or susceptibility to arrhythmia
6. Diagnosed eating disorder
7. Neuroleptic or oral cortisone medication
8. Excess alcohol consumption (women > 16, men > 24 portions/week).
9. No other diseases, medications, or life situations that would prevent them from successfully completing the study
Recruitment start date
01/05/2008
Recruitment end date
28/02/2010
Locations
Countries of recruitment
Finland
Trial participating centre
Institute of Public Health and Clinical Nutrition
Kuopio
70211
Finland
Funders
Funder type
Research organisation
Funder name
The Finnish Funding Agency for Technology and Innovation (Tekes) (Finland) (Grant 40100/07)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 protocol and results in http://www.ncbi.nlm.nih.gov/pubmed/22792447
Publication citations
-
Protocol and results
Karhunen L, Lyly M, Lapveteläinen A, Kolehmainen M, Laaksonen DE, Lähteenmäki L, Poutanen K, Psychobehavioural factors are more strongly associated with successful weight management than predetermined satiety effect or other characteristics of diet., J Obes, 2012, 2012, 274068, doi: 10.1155/2012/274068.