UMIN-CTR Clinical Trial

Public title

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.

Acronym

N-3 fatty acid supplementation in combination with life style modification

Scientific Title

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.

Scientific Title:Acronym

N-3 fatty acid supplementation in combination with life style modification

Region

Europe

Condition

overweight women

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Pavel Sedlacek M.D.

Organization

Faculty of Medicine in Pilsen, Charles University, Czech Republic

Division name

Department of Public Health and Preventive Medicine

Zip code

Address

Lidicka 4, 301 66 Pilsen, Czech Republic

TEL

00420377593195

Email

pavel.sedlacek@lfp.cuni.cz

Name of contact person

1st name
Middle name
Last name	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

Zip code

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

Institute

Charles University, Czech Republic

Institute

Department

Personal name

Organization

Charles University, Czech Republic

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

04

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

03

Month

06

Day

Date of IRB

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

Other related information

Registered date

2017

Year

04

Month

27

Day

Last modified on

2017

Year

04

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031131