UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026524
Receipt number R000030418
Scientific Title Effect of Daily Ingestion of High-Lycopene Tomato "PR-7" on Lipid Metabolism for 8 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group
Date of disclosure of the study information 2017/03/13
Last modified on 2018/03/19 09:58:04

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Basic information

Public title

Effect of Daily Ingestion of High-Lycopene Tomato "PR-7" on Lipid Metabolism for 8 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group

Acronym

Beneficial Effects of High-Lycopene Tomato "PR-7" on Lipid Metabolism

Scientific Title

Effect of Daily Ingestion of High-Lycopene Tomato "PR-7" on Lipid Metabolism for 8 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group

Scientific Title:Acronym

Beneficial Effects of High-Lycopene Tomato "PR-7" on Lipid Metabolism

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prove clinical benefits associated with 8 week daily ingestion of high-lycopene tomato "PR-7" on lipid metabolism. Additionally to examine anti-oxidant effects, reduction of VFA, improvement of glucose metabolism, and anti-fatigue effects in order to evaluate the comprehensive effects of high-lycopene tomato "PR-7" for health promotion and health maintenance.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

TC, LDL-C, HDL-C, TG, LDL-C/HDL-C, and non-HDL at 4 and 8 weeks after beginning the ingestion of test food.

Key secondary outcomes

serum lycopene, serum alpha-carotene, serum beta-carotene, serum vitamin A, MDA-LDL, serum-LPO, urinary isoprostane, urinary HEL, LOX-index, sLOX-1, LAB, visceral fat area (using impedance methods), abdominal subcutaneous fat area (using impedance methods), abdominal fat area (using impedance methods), body weight, body fat percentage, BMI, waist, FPG, HbA1c, blood pressure, POMS 2 full-length versions for adults, VAS questionnaire assessed fatigue, stress etc.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Daily ingestion of 50 g semi-dried tomato of high-lycopene tomato "PR-7" for 8 weeks.

Interventions/Control_2

Daily ingestion of 50 g semi-dried tomato of placebo tomato (lycopene-free tomato) for 8 weeks.

Interventions/Control_3


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

35 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Subjects whose LDL-C is >=120 mg/dl and <160 mg/dl.
2. Subjects who agree to participate in this study with a written informed consent.

Key exclusion criteria

1. Subjects who are under physician's advice, treatment, and/or medication for dyslipidemia, diabetes, and/or obesity.
2. Subjects whose BMI is >=30 kg/m2.
3. Subjects with familial hypercholesterolemia.
4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
5. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
7. Subjects with severe anemia.
8. Pre- or post-menopausal women complaining of obvious physical changes.
9. Subjects who are at risk of having allergic reactions to drugs or foods especially based on tomato, Japanese cedar, Japanese cypress, or grass.
10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels.
11. Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism.
12. Subjects who regularly take drugs, functional foods, and/or supplements which would affect BW and BFP.
13. Smokers.
14. Alcohol addicts or subjects with eating disordered lifestyle.
15. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
16. Pregnant or lactating women or women who expect to be pregnant during this study.
17. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
18. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Department of Medical Management and Informatics

Zip code


Address

59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan

TEL

011-385-4411

Email

nishihira@do-johodai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Health Information Science Center

Zip code


Address

59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan

TEL

011-385-4430

Homepage URL


Email

nishihira@do-johodai.ac.jp


Sponsor or person

Institute

Hokkaido Information University

Institute

Department

Personal name



Funding Source

Organization

NARO Bio-oriented Technology Research Advancement Institution

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

TAKII & COMPANY, LIMITED

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

北海道情報大学 保健センター(北海道)


Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 02 Month 13 Day

Date of IRB


Anticipated trial start date

2017 Year 05 Month 27 Day

Last follow-up date

2017 Year 07 Month 31 Day

Date of closure to data entry

2017 Year 09 Month 18 Day

Date trial data considered complete

2017 Year 09 Month 25 Day

Date analysis concluded

2018 Year 02 Month 22 Day


Other

Other related information



Management information

Registered date

2017 Year 03 Month 13 Day

Last modified on

2018 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030418


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name