Dried Purple Laver (Nori) as a Food Source of Vitamin B12 in Vegetarians

NCT ID: NCT05614960

Last Updated: 2023-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2023-03-31

Brief Summary

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This is an intervention study aiming to understand the bioavailability of vitamin B12 from nori for vegetarians.

Detailed Description

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Thirty vegetarian participants will be randomly assigned to one of three intervention arms: (1) 5g of nori (4 sheets, containing 2.4μg vitamin B12), (2) 8g nori (7 sheets, containing 4μg vitamin B12), (3) control group (no nori). At baseline and end of 4 weeks, participants will be measured on serum vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine and folate.

Conditions

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Vitamin B 12 Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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2.4μg vitamin B12

Participants need to consume 4 sheets (5g) of dried purple laver (Nori) daily for 4 weeks.

Group Type EXPERIMENTAL

Dried purple laver (Nori)

Intervention Type OTHER

Dried purple laver (Nori) that has been test to have bioactivity vitamin B12 will be given for intervention groups.

4μg vitamin B12

Participants need to consume 7 sheets (8g) of dried purple laver (Nori) daily for 4 weeks.

Group Type EXPERIMENTAL

Dried purple laver (Nori)

Intervention Type OTHER

Dried purple laver (Nori) that has been test to have bioactivity vitamin B12 will be given for intervention groups.

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dried purple laver (Nori)

Dried purple laver (Nori) that has been test to have bioactivity vitamin B12 will be given for intervention groups.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Vegetarians (including vegan, ovo-vegetarian, lacto-vegetarian, lacto-ovo vegetarian)
* Duration of the vegetarian diet: at least 1 year
* Aged 20-60 years old
* Have not taken vitamin B12 or folate supplement within 1 year
* Willing to adhere to study intervention and be tested for vitamin B12 related biomarkers.
* Familiar with LINE application on smartphone

Exclusion Criteria

* Any disease or surgery that affects the vitamin B12 status (Pernicious anemia, Gastrointestinal disease and surgery, Pancreatic diseases, Chronic kidney disease)
* Hyperthyroidism
* Previous adverse reaction to nori
* Have taken antacid or metformin in the past 1 week
* Alcoholic and not willing to abstinence from alcoholic beverages
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Tina Hsueh-Ting Chiu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tina Hsueh-Ting Chiu, PhD

Role: PRINCIPAL_INVESTIGATOR

Fu-Jen Catholic University, Department of Nutritional Science

Locations

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Department of Nutritional Science, Fu-Jen Catholic University

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

References

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Chiu THT, Kao YC, Wang LY, Chang HR, Lin CL. A Dietitian-Led Vegan Program May Improve GlycA, and Other Novel and Traditional Cardiometabolic Risk Factors in Patients With Dyslipidemia: A Pilot Study. Front Nutr. 2022 Mar 24;9:807810. doi: 10.3389/fnut.2022.807810. eCollection 2022.

Reference Type BACKGROUND
PMID: 35399690 (View on PubMed)

Takenaka S, Sugiyama S, Ebara S, Miyamoto E, Abe K, Tamura Y, Watanabe F, Tsuyama S, Nakano Y. Feeding dried purple laver (nori) to vitamin B12-deficient rats significantly improves vitamin B12 status. Br J Nutr. 2001 Jun;85(6):699-703. doi: 10.1079/bjn2001352.

Reference Type BACKGROUND
PMID: 11430774 (View on PubMed)

Suzuki H. Serum vitamin B12 levels in young vegans who eat brown rice. J Nutr Sci Vitaminol (Tokyo). 1995 Dec;41(6):587-94. doi: 10.3177/jnsv.41.587.

Reference Type BACKGROUND
PMID: 8926531 (View on PubMed)

Schwarz J, Dschietzig T, Schwarz J, Dura A, Nelle E, Watanabe F, Wintgens KF, Reich M, Armbruster FP. The influence of a whole food vegan diet with Nori algae and wild mushrooms on selected blood parameters. Clin Lab. 2014;60(12):2039-50. doi: 10.7754/clin.lab.2014.140527.

Reference Type BACKGROUND
PMID: 25651739 (View on PubMed)

Rauma AL, Torronen R, Hanninen O, Mykkanen H. Vitamin B-12 status of long-term adherents of a strict uncooked vegan diet ("living food diet") is compromised. J Nutr. 1995 Oct;125(10):2511-5. doi: 10.1093/jn/125.10.2511.

Reference Type BACKGROUND
PMID: 7562085 (View on PubMed)

Watanabe F, Yabuta Y, Bito T, Teng F. Vitamin B(1)(2)-containing plant food sources for vegetarians. Nutrients. 2014 May 5;6(5):1861-73. doi: 10.3390/nu6051861.

Reference Type BACKGROUND
PMID: 24803097 (View on PubMed)

Rizzo G, Lagana AS, Rapisarda AM, La Ferrera GM, Buscema M, Rossetti P, Nigro A, Muscia V, Valenti G, Sapia F, Sarpietro G, Zigarelli M, Vitale SG. Vitamin B12 among Vegetarians: Status, Assessment and Supplementation. Nutrients. 2016 Nov 29;8(12):767. doi: 10.3390/nu8120767.

Reference Type BACKGROUND
PMID: 27916823 (View on PubMed)

Huang QN, Watanabe F, Koseki K, He RE, Lee HL, Chiu THT. Effect of roasted purple laver (nori) on vitamin B12 nutritional status of vegetarians: a dose-response trial. Eur J Nutr. 2024 Dec;63(8):3269-3279. doi: 10.1007/s00394-024-03505-9. Epub 2024 Oct 1.

Reference Type DERIVED
PMID: 39352476 (View on PubMed)

Other Identifiers

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FuJenCU

Identifier Type: -

Identifier Source: org_study_id

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