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

Study Overview
=================
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.

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

Conditions
-----------------
Vitamin B 12 Deficiency

Intervention / Treatment
-----------------
* Other: Dried purple laver (Nori)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2.4μg vitamin B12<br>Participants need to consume 4 sheets (5g) of dried purple laver (Nori) daily for 4 weeks. | Other: Dried purple laver (Nori)<br>* Dried purple laver (Nori) that has been test to have bioactivity vitamin B12 will be given for intervention groups.<br>|
| Experimental: 4μg vitamin B12<br>Participants need to consume 7 sheets (8g) of dried purple laver (Nori) daily for 4 weeks. | Other: Dried purple laver (Nori)<br>* Dried purple laver (Nori) that has been test to have bioactivity vitamin B12 will be given for intervention groups.<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Change in homocysteine in 4 weeks | Assessing the change in serum homocysteine after consuming varying doses of nori | 4 weeks (Week 4 - Baseline) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin B12, Vegetarian diet, Purple laver (Porphyra sp.), Nori