UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on the visceral fat area in healthy subjects

Acronym

Effects of consumption of the test food on the visceral fat area in healthy subjects

Scientific Title

Effects of consumption of the test food on the visceral fat area in healthy subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on the visceral fat area in healthy subjects

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of continuous consumption of the test food on the visceral fat area in healthy subjects

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The visceral fat area at 12 weeks after the start of the test-food consumption (12w)

Key secondary outcomes

1. The visceral fat area at eight weeks after the start of test-food consumption (8w)

2. The subcutaneous fat area, total fat area, body weight, body mass index (BMI), abdominal circumference, waist circumference, body fat percentage, fat mass, lean body mass, and muscle mass at 8w and 12w

3. The serum levels of total cholesterol (T-Ch), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), and triglyceride (TG)

4. Each item of the questionnaire at 4w, 8w, and 12w

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks

Test food: Capsule containing plant extract

Administration: Take three capsules once per day with water immediately before snack or dinner.

*If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: 12 weeks

Test food: Capsule not containing plant extract

Administration: Take three capsules once per day with water immediately before snack or dinner.

*If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_3

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Japanese healthy subjects aged 20 or over to under 65 years old
2. Subjects who have the habit of snacking (i.e., the habit of consuming fructose-containing foods)
3. Subjects who are judged as eligible to participate in the study by the physician
4. Subjects whose fructose intakes are relatively high in the dietary survey during the last three days before screening (before consumption; Scr)
5. Subjects whose values of BMI are 23 kg/m² or more and less than 30 kg/m² at Scr
6. Subjects who receive a full explanation of the procedures in the study, understand the explanation, and provide informed consent signed by themselves
7. Among the subjects who met the inclusion criteria, select 198 of them as the combination of the subjects with the minimum standard deviation of the visceral fat area at Scr

Key exclusion criteria

Subjects (who)
1.undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2.have a pacemaker or an implantable cardioverter defibrillator
3.undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4.take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
5.take herb or supplements with hypoglycemic effects in daily use
6.planning to undergo a surgical operation during the intervention period or within two weeks from the date of finish of the intervention period
7.taking medicines (include herbal medicines) and supplements
8.allergic to medications and/or the test-food-related products
9.have weak stomach and may feel discomfort such as convergence in the stomach, particularly when taking beverages containing tannin such as strong green tea, black tea, or coffee
10.pregnant, lactation, or planning to become pregnant
11.have unhealthy eating habits or irregular rhythm of life
12.drink an excess of alcohol
*weekly average of alcohol intake is more than 60 g/day [Reference materials for the promotion of Health Japan 21 (the second term)]
13.have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
14.have donated blood component or 200-mL whole blood within the last one month before the agreement to participate in this trial
15.have donated 400-mL whole blood within the last three month before the agreement to participate in this trial
16.are scheduling to have a total of more than 1,200 mL of blood drawn until the end of this study from the 12 months before the date of consent obtained
17.judged as ineligible to participate in the study by the physician

Target sample size

180

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

NAGAOKA CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2020

Year

11

Month

16

Day

URL releasing protocol

Unpublished

Publication of results

Published

URL related to results and publications

https://doi.org/10.31989/ffhd.v12i5.927

Number of participants that the trial has enrolled

198

Results

Overall, this study showed that Eucalyptus leaf extract (ELE) containing oenothein B reduces visceral fat area (VFA) by consecutive ingestion for 12 weeks in healthy Japanese adults with a BMI >= 23 and < 30 kg/m². The effect was determined to be as effective as Food for Specified Health Uses (FOSHU) and was considered a clinically meaningful improvement. More specifically, ELE containing oenothein B is considered to reduce fructose intake-induced visceral fat. ELE was safe for use in this study.

Results date posted

2022

Year

09

Month

26

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Placebo group (n = 95)
Sex (Male) 45 (47.4%)
Sex (Female) 50 (52.6%)
Age (Years) 47.7 (10.4)
Height (cm) 164.6 (8.9)
Nonspecific IgE (IU/mL) 328.3 (1373.0)

Intervention group (n = 94)
Sex (Male) 45 (47.9%)
Sex (Female) 49 (52.1%)
Age (Years) 46.5 (10.7)
Height (cm) 164.4 (8.5)
Nonspecific IgE (IU/mL) 352.2 (1269.4)

Participant flow

Assessed for eligibility (n = 721)
Randomized (n = 198)
Allocated to the placebo group (n = 99)
FAS and SAF
Analyzed (n = 96)
PPS
Analyzed (n = 95)

Allocated to the intervention group (n = 99)
FAS and SAF
Analyzed (n = 98)
PPS
Analyzed (n = 94)

Adverse events

Serious adverse events were not observed. The incidence of adverse events was 8.3% and 8.2% in the placebo (n = 96) and intervention (n = 98) groups, respectively (8 events each; Data not shown). These symptoms were considered by the principal doctor to be mild since they were temporary, and reversible by medication. The doctor confirmed that these phenomena were not causally related to the test foods.

Outcome measures

The intervention group exhibited significantly lower scores at 12 weeks after the start of the intervention for visceral fat area (VFA) than the placebo group (P = 0.012). The difference between the scores of the two groups at 12 weeks after was -5.6 cm² (95% CI, -10.0 to -1.3). Comparing the changes in VFA over time, we found that VFA after 12 weeks decreased significantly by 6.5 cm² in the intervention group compared to baseline (P = 1.5 x 10^-5); there was no significant change in VFA in the placebo group (P = 0.561).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

11

Month

11

Day

Date of IRB

2020

Year

11

Month

11

Day

Anticipated trial start date

2020

Year

11

Month

17

Day

Last follow-up date

2021

Year

06

Month

19

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

16

Day

Last modified on

2022

Year

09

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048478