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

Primary Purpose

Vitamin B 12 Deficiency

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Dried purple laver (Nori)

About this trial

This is an interventional prevention trial for Vitamin B 12 Deficiency focused on measuring Vitamin B12, Vegetarian diet, Purple laver (Porphyra sp.), Nori

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Nutritional Science, Fu-Jen Catholic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

2.4μg vitamin B12

4μg vitamin B12

Control

Arm Description

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

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

No intervention

Outcomes

Primary Outcome Measures

Change in holotranscobalamin in 4 weeks

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

Change in methylmalonic acid in 4 weeks

Assessing the change in serum methylmalonic acid after consuming varying doses of nori

Secondary Outcome Measures

Change in serum vitamin B12 concentration in 4 weeks

Assessing the change in serum vitamin B12 after consuming varying doses of nori

Change in homocysteine in 4 weeks

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

Full Information

NCT ID

NCT05614960

First Posted

November 4, 2022

Last Updated

May 30, 2023

Sponsor

Fu Jen Catholic University

1. Study Identification

Unique Protocol Identification Number

NCT05614960

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

November 7, 2022 (Actual)

Primary Completion Date

March 31, 2023 (Actual)

Study Completion Date

March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fu Jen Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin B 12 Deficiency

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2.4μg vitamin B12

Arm Type

Experimental

Arm Description

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

Arm Title

4μg vitamin B12

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

No intervention

Intervention Type

Other

Intervention Name(s)

Dried purple laver (Nori)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in holotranscobalamin in 4 weeks

Description

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

Time Frame

4 weeks (Week 4 - Baseline)

Title

Change in methylmalonic acid in 4 weeks

Description

Assessing the change in serum methylmalonic acid after consuming varying doses of nori

Time Frame

4 weeks (Week 4 - Baseline)

Secondary Outcome Measure Information:

Title

Change in serum vitamin B12 concentration in 4 weeks

Description

Assessing the change in serum vitamin B12 after consuming varying doses of nori

Time Frame

4 weeks (Week 4 - Baseline)

Title

Change in homocysteine in 4 weeks

Description

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

Time Frame

4 weeks (Week 4 - Baseline)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tina Hsueh-Ting Chiu, PhD

Organizational Affiliation

Fu-Jen Catholic University, Department of Nutritional Science

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Nutritional Science, Fu-Jen Catholic University

City

New Taipei City

ZIP/Postal Code

24205

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35399690

Citation

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.

Results Reference

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PubMed Identifier

11430774

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.

Results Reference

background

PubMed Identifier

8926531

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.

Results Reference

background

PubMed Identifier

25651739

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.

Results Reference

background

PubMed Identifier

7562085

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.

Results Reference

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PubMed Identifier

24803097

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.

Results Reference

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PubMed Identifier

27916823

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.

Results Reference

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

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