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
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
Scientific
Institute of Public Health and Clinical Nutrition
University of Eastern Finland
P.O.Box 1627 (Yliopistonranta 1)
Kuopio
70211
Finland
Study information
| Study design | Clinical randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Foods for weight management: a randomized controlled trial |
| Study acronym | ELIPA |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2008 |
| Completion date | 28/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 82 |
| Key inclusion criteria | 1. Body mass index 3040 kg/m2 2. Age 3065 years |
| Key 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 |
| Date of first enrolment | 01/05/2008 |
| Date of final enrolment | 28/02/2010 |
Locations
Countries of recruitment
- Finland
Study participating centre
70211
Finland
Sponsor information
University/education
P.O.Box 1627 (Yliopistonranta 1)
Kuopio
70211
Finland
| hannu.mykkanen@uef.fi | |
"ROR" |
https://ror.org/00cyydd11 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
