UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of a 12-week non-energy-restricted diet with n-3 fatty acid supplementation and moderate physical activity on biochemical parameters, body composition, and physical fitness in women with pre-obesity. Three-arm randomised trial.
Title of the study (Brief title)	N-3 fatty acid supplementation in combination with life style modification
Region	Europe

Condition
Condition	overweight women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We sought to examine whether eicosapentaenoic and docosahexaenoic acid supplementation at a relatively low dose of ~0.6 g/day, could modulate the effects of life style modification (iso-caloric diet and moderate physical activity) in healthy women with pre-obesity. The major goal of the study was to characterize the effect of the combined intervention on modulation of adipose tissue function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body weight, Body Mass Index, waist circumference, bioelectrical impedance analysis, spiroergometry (VO2 max.), 24-hours dietary recall, adiponectin, leptin, insulin, follistatin, brain-derived neurotrophic factor, leukocyte inhibitory factor, tumor necrosis factor alpha, interleukin 6, interleukin 8, vitamin D.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom Other
Interventions/Control_1	Lifestyle modification (in intervened groups: a) with lifestyle modification and b)group with lifestyle modification and n-3 fatty acids supplementation): Lifestyle modification consisted of a 3-month complex "self-tailored" program of defined and supervised physical activity and diet. Physical activity included 30 minutes of continuous walking from the total minimum amount of 10.000 steps a day (monitored by pedometers) and twice a week 1.5 hour of driven and continuously monitored physical activity, where part of aerobic activity respected the initial physical fitness, measured by spiroergometry, continued to grow and was directed according to Karvonen`s heart rate reserve method and Borg scale of subjective perception of the intensity of the load in the aerobic zone load (50-75 % of their individual VO2R) for 45 minutes on training simulators. Personalized diet recommendations were developed on the basis of energy expenditure assessment in combination with habitual caloric intake assessment. Dietary counselling was individualized for each person and participants were encouraged not to reduce caloric intake under the habitual amount, but rather to increase intake of vegetables, fruits, legumes, seeds, nuts and fiber rich complex carbohydrates, vegetable oils with monounsaturated fatty acids, fish and low fat dairy products; and decrease intake of saturated and trans fat, salt, sugars, and red meat. They were instructed to limit intake of vegetable oils with polyunsaturated n-6 fatty acids, and exclude highly processed food from the diet as much as possible. Based on recommended energy content, the participants obtained framework diet plans and were initially educated and checked every week in required diet by dieticians. Control group: No lifestyle modification.
Interventions/Control_2	Supplementation with n-3 polyunsaturated fatty acids (in intervened group with lifestyle modification and n-3 polyunsaturated fatty acids supplementation): eicosapentaenoic and docosahexaenoic acid supplementation at a dose of ~0.6 g per day for 3 months. Control group and group with lifestyle modification: corn oil supplementation.
Interventions/Control_3	Group with placebo: corn oil supplementation without lifestyle modification.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Female
Key inclusion criteria	20-60 years of age, women, fulfilling two of three criteria for pre-obesity (overweight), that is Body Mass Index (BMI) in the range of 25-29.9 kgm-2, waist circumference equal or higher than 80 cm, body fat measured by bioelectrical impedance analysis (BIA) equal or higher than 25 percent of total body weight. Ability and willingness to adhere to the protocol and signed and dated written informed consent obtained before the study
Key exclusion criteria	pregnancy and lactation, smoking, long-term medication, history of cardiovascular, endocrine, and metabolic diseases, cancer, significant recent weight gain or loss (more than 5 percent of total body weight within the past 3 months)
Target sample size	34

Research contact person
Name of lead principal investigator	Pavel Sedlacek M.D.
Organization	Faculty of Medicine in Pilsen, Charles University, Czech Republic
Division name	Department of Public Health and Preventive Medicine
Address	Lidicka 4, 301 66 Pilsen, Czech Republic
TEL	00420377593195
Email	pavel.sedlacek@lfp.cuni.cz

Public contact
Name of contact person	Associate Professor Dana Mullerova M.D., Ph.D.
Organization	Faculty of Medicine in Pilsen, Charles University, Czech Republic
Division name	Department of Public Health and Preventive Medicine
Address	Lidicka 4, 301 66 Pilsen, Czech Republic
TEL	00420377593191
Homepage URL	http://www.lfp.cuni.cz/oddeleni/29-ustav-hygieny-a-preventivni-mediciny.html
Email	dana.mullerova@lfp.cuni.cz

Sponsor
Institute	Charles University, Czech Republic
Institute
Department

Funding Source
Organization	Charles University, Czech Republic
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 06 Day
Anticipated trial start date	2014 Year 03 Month 10 Day
Last follow-up date	2014 Year 06 Month 08 Day
Date of closure to data entry	2014 Year 06 Month 13 Day
Date trial data considered complete	2014 Year 06 Month 13 Day
Date analysis concluded	2016 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 27 Day
Last modified on	2017 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031131