Foods for weight management (Elintarvikkeita painonhallintaan)

ISRCTN ISRCTN67529475
DOI https://doi.org/10.1186/ISRCTN67529475
Secondary identifying numbers 40100/07 (Tekes)
Submission date
04/10/2013
Registration date
29/01/2014
Last edited
05/06/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Leila Karhunen
Scientific

Institute of Public Health and Clinical Nutrition
University of Eastern Finland
P.O.Box 1627 (Yliopistonranta 1)
Kuopio
70211
Finland

Study information

Study designClinical randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleFoods for weight management: a randomized controlled trial
Study acronymELIPA
Study objectivesIt 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(s)The Ethics Committee of the District Hospital Region of Northern Savo and the Kuopio University Hospital; Ref: 46/2008
Health condition(s) or problem(s) studiedObesity
InterventionParticipants 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 typeOther
Primary outcome measure1. Body weight measured by a digital scale at baseline, 8, 12, 24 weeks and at follow-up.
Secondary outcome measures1. 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 study start date01/05/2008
Completion date28/02/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Total final enrolment82
Key inclusion criteria1. Body mass index 30–40 kg/m2
2. Age 30–65 years
Key exclusion criteria1. 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
Date of first enrolment01/05/2008
Date of final enrolment28/02/2010

Locations

Countries of recruitment

  • Finland

Study participating centre

Institute of Public Health and Clinical Nutrition
Kuopio
70211
Finland

Sponsor information

University of Eastern Finland (Finland)
University/education

P.O.Box 1627 (Yliopistonranta 1)
Kuopio
70211
Finland

Email hannu.mykkanen@uef.fi
ROR logo "ROR" https://ror.org/00cyydd11

Funders

Funder type

Research organisation

The Finnish Funding Agency for Technology and Innovation (Tekes) (Finland) (Grant 40100/07)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol and results 01/01/2012 Yes No
Results article results 02/12/2020 03/12/2020 Yes No
Results article 17/05/2023 05/06/2023 Yes No

Editorial Notes

05/06/2023: Publication reference added.
03/12/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.