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

NCT05614960 | Completed

• 1 other identifier: FuJenCU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin B 12 Deficiency

Keywords

Vitamin B12; Vegetarian diet; Purple laver (Porphyra sp.); Nori

Outcome Measures

Primary Outcomes (2)

• Change in holotranscobalamin in 4 weeks

  Assessing the change in serum holotranscobalamin after consuming varying doses of nori

  4 weeks (Week 4 - Baseline)

• 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 Outcomes (2)

• Change in serum vitamin B12 concentration in 4 weeks

  4 weeks (Week 4 - Baseline)

• Change in homocysteine in 4 weeks

  4 weeks (Week 4 - Baseline)

Study Arms (3)

2.4μg vitamin B12

EXPERIMENTAL

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

Other: Dried purple laver (Nori)

4μg vitamin B12

EXPERIMENTAL

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

Other: Dried purple laver (Nori)

Control

NO INTERVENTION

No intervention

Interventions

Dried purple laver (Nori) OTHER

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

2.4μg vitamin B12; 4μg vitamin B12

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fu Jen Catholic University: lead

Study Sites (1)

Department of Nutritional Science, Fu-Jen Catholic University

New Taipei City, 24205, Taiwan

Location

Related Publications (8)

• 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.

  PMID: 35399690 BACKGROUND

• 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.

  PMID: 11430774 BACKGROUND

• 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.

  PMID: 8926531 BACKGROUND

• 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.

  PMID: 25651739 BACKGROUND

• 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.

  PMID: 7562085 BACKGROUND

• 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.

  PMID: 24803097 BACKGROUND

• 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.

  PMID: 27916823 BACKGROUND

• 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.

  PMID: 39352476 DERIVED

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Tina Hsueh-Ting Chiu, PhD

  Fu-Jen Catholic University, Department of Nutritional Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: November 7, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)