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

Not Applicable

Completed

• Conditions: Vitamin B 12 Deficiency
• Interventions: Other: Dried purple laver (Nori)

• Registration Number: NCT05614960
• Lead Sponsor: Fu Jen Catholic University

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.

Study Timeline

• Study First Submitted: 2022-11-04
• Study Start: 2022-11-07
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-14
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.4μg vitamin B12	Dried purple laver (Nori)	Participants need to consume 4 sheets (5g) of dried purple laver (Nori) daily for 4 weeks.
4μg vitamin B12	Dried purple laver (Nori)	Participants need to consume 7 sheets (8g) of dried purple laver (Nori) daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in holotranscobalamin in 4 weeks	4 weeks (Week 4 - Baseline)	Assessing the change in serum holotranscobalamin after consuming varying doses of nori
Change in methylmalonic acid in 4 weeks	4 weeks (Week 4 - Baseline)	Assessing the change in serum methylmalonic acid after consuming varying doses of nori

Secondary Outcome Measures

Name	Time	Method
Change in homocysteine in 4 weeks	4 weeks (Week 4 - Baseline)	Assessing the change in serum homocysteine after consuming varying doses of nori
Change in serum vitamin B12 concentration in 4 weeks	4 weeks (Week 4 - Baseline)	Assessing the change in serum vitamin B12 after consuming varying doses of nori

Trial Locations

Locations (1)

Department of Nutritional Science, Fu-Jen Catholic University; 🇨🇳 New Taipei City, Taiwan