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

Vitamin B 12 Deficiency Clinical Trial

Official title:

The Bioavailability of Vitamin B12 From Nori in Vegetarians: a Dose Response Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05614960
• Other study ID #: FuJenCU
• Status: Completed
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: Fu Jen Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Nutritional Science, Fu-Jen Catholic University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in holotranscobalamin in 4 weeks	Assessing the change in serum holotranscobalamin after consuming varying doses of nori	4 weeks (Week 4 - Baseline)
Primary	Change in methylmalonic acid in 4 weeks	Assessing the change in serum methylmalonic acid after consuming varying doses of nori	4 weeks (Week 4 - Baseline)
Secondary	Change in serum vitamin B12 concentration in 4 weeks	Assessing the change in serum vitamin B12 after consuming varying doses of nori	4 weeks (Week 4 - Baseline)
Secondary	Change in homocysteine in 4 weeks	Assessing the change in serum homocysteine after consuming varying doses of nori	4 weeks (Week 4 - Baseline)