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July. 06, 2021

Jan. 01, 2025

jRCTs021210018

Evaluation of the effect of broccoli-supplement intake on blood antioxidant levels and search for new NRF2 markers

Evaluation of the effect of broccoli-supplements intake on blood antioxidant levels and search for new biomarkers

July. 07, 2022

30

Age and SFN absorption are shown as median values. Active; N=15 (Men;6, Female;9), 24 years-old, SFN absorption 3.97 (0.87-11.48) Placebo; N=15 (Men;7, Female;8), 22 years-old, SFN absorption 3.97 (0.73-13.15)

Thirty (15 in the active group and 15 in the placebo group) started the study. 1 (1 in placebo group) discontinued the test due to own reason. 29 (14 in placebo group and 15 in active group) completed the study.

The following symptoms were observed in active group but these symptoms were not observed in placebo group. (Heartburn; 2, physical discomfort; 1, stomach pain; 1, stomach discomfort;1, a feeling of esophageal discomfort:1) Since all of these were observed in the active group, the principal investigator determined that there was a causal relationship with the test food. Pain and swelling of the arm and blue bruises on the arm occurred in one subject. The principal investigator determined that there was a causal relationship with the blood draw. These adverse events were confirmed to have resolved. No serious adverse events were observed.

The amount of change before and after the intervention was compared. Bis-S-HPE-AM was significantly higher in active group than in placebo group (Active; 25.97+-31.00 nM, Placebo; 8.29+-36.63 nM). Other measurement items analyzed by LC-MS/MS including glutathione showed no significant differences.BAP was not significantly different between placebo and active groups (Active; 5.60+-256.82 micromolar, Placebo;-79.50+-232.68 micromolar, Mean+-SD).Metabolome analysis detected 261 items. None of which showed significant differences between the two groups. Liver function test values (AST etc.) also showed no difference between the two groups. In active group, no correlation was found between SFN absorption and blood antioxidant capacity, metabolome.

It was found that healthy adults increased Bis-S-HPE-AM in plasma by ingesting broccoli-supplements for 14 days. However BAP, blood antioxidant capacity and metabolomes were not changed. Future studies will continue statistical analysis, including multivariate analysis, as a retrospective study.

Jan. 01, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs021210018

Itoh Ken

Hirosaki University Graduate School of Medicine

5 Zaifu-cho Hirosaki city, Aomori

+81-172-39-5158

itohk@hirosaki-u.ac.jp

Itoh Ken

Hirosaki University Graduate School of Medicine

5 Zaifu-cho Hirosaki city, Aomori

+81-172-39-5158

itohk@hirosaki-u.ac.jp

Complete

July. 06, 2021

30

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

basic science

Subjects who satisfies all follwing criteria.
1.Healthy adults aged >= 20 years to =< 35 years at the start of the trial.
2.Who can make self-judgment, voluntarily agree to participate to this trial, and provide written informed consent.
3.Those who are judged to have high SFN absorption efficiency in a preliminary study of 20-40 people.

1. Subjects who have food allergy to the test supplements
2. Subjects who are pregnant, will hope pregnancy, or breast-feed during the study period
3. Subjects who suffer from psychiatric disease or express psychiatric symptoms
4. Subjects who join other clinical trials
5. Subjects who are judged unsuitable for this trial by the principal investigator

20age old over
35age old under

Both

Healthy adults

Six broccoli-based supplements or placebo capsules per days will be taken for 14 days.

1. Antioxidant capacity of plasma (GSH, GSSH, GSH polysulfides, GSSG, Oxidized GSH polysulfides, GSH/GSSG, Cysteine (Cys), CysSSH, Cys polysulfides, Cystine, Oxidized Cys polysulfides, Cys/Cystine, Homocysteine, Homocysteine persulfide, Bis-S-HPE-AM, Bis-SS-HPE-AM, BAP)
2. Blood metabolites

1.SFN absorption efficiency
2.Biochemical test (AST, ALT, T-Bil, gamma-GTP)
3.Relationship between SFN absorption efficiency and antioxidative level in plasma
4.Relationship between SFN absorption efficiency and metabolites in plasma

Natural Wellness Research Department, Innovation Division, KAGOME, CO., LTD.
Applicable
Hirosaki University General Certified Review Board
1 Bunkyocho, Hirosaki, Aomori

+81-172-39-5362

crb-hirosaki@hirosaki-u.ac.jp
Approval

June. 30, 2021

none

History of Changes

No Publication date
5 Jan. 01, 2025 (this page) Changes
4 Mar. 07, 2022 Detail Changes
3 Sept. 08, 2021 Detail Changes
2 Aug. 04, 2021 Detail Changes
1 July. 06, 2021 Detail