Vitamin B 12 DeficiencyNCT05614960
Dried Purple Laver (Nori) as a Food Source of Vitamin B12 in Vegetarians
A study testing Dried purple laver (Nori) in people with Vitamin B 12 Deficiency, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
This is an intervention study aiming to understand the bioavailability of vitamin B12 from nori for vegetarians. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin B 12 Deficiency
- What is being tested?
- Dried purple laver (Nori)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Nov 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Nutritional Science, Fu-Jen Catholic University
New Taipei City, 24205
About this study
Official title: The Bioavailability of Vitamin B12 From Nori in Vegetarians: a Dose Response Study
This is an intervention study aiming to understand the bioavailability of vitamin B12 from nori for vegetarians.
Read the 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.
- Conditions
- Vitamin B 12 Deficiency
- Being tested
- Dried purple laver (Nori)
- Keywords
- Vitamin B12, Vegetarian diet, Purple laver (Porphyra sp.), Nori
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried purple laver (Nori)Other
Dried purple laver (Nori) that has been test to have bioactivity vitamin B12 will be given for intervention groups.
| Study group | Role | What they receive |
|---|---|---|
| 2.4μg vitamin B12 | Experimental | Participants need to consume 4 sheets (5g) of dried purple laver (Nori) daily for 4 weeks. Receives: 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. Receives: Other: Dried purple laver (Nori) |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in holotranscobalamin in 4 weeks
Assessing the change in serum holotranscobalamin after consuming varying doses of nori
Measured: 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
Measured: 4 weeks (Week 4 - Baseline)
Secondary outcomes (2)
Change in serum vitamin B12 concentration in 4 weeks
Assessing the change in serum vitamin B12 after consuming varying doses of nori
Measured: 4 weeks (Week 4 - Baseline)
Change in homocysteine in 4 weeks
Assessing the change in serum homocysteine after consuming varying doses of nori
Measured: 4 weeks (Week 4 - Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start7 Nov 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vitamin B 12 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tina Hsueh-Ting Chiu, Fu Jen Catholic University
- Investigators
- Tina Hsueh-Ting Chiu, PhD, Principal investigator, Fu-Jen Catholic University, Department of Nutritional Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614960
- Sponsor's protocol ID
- FuJenCU
- Status last verified
- May 2023
- First submitted
- 4 Nov 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35399690Takenaka 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.
PubMed 11430774Suzuki 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.
PubMed 8926531Schwarz 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.
PubMed 25651739Rauma 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.
PubMed 7562085Watanabe 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.
PubMed 24803097Rizzo 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.
PubMed 27916823Huang 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.
PubMed 39352476
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bioavailability of Vitamin B12 From Nori in Vegetarians: a Dose Response Study
- ClinicalTrials.gov ID
- NCT05614960
- Acronym / sponsor ID
- FuJenCU
- Conditions
- Vitamin B 12 Deficiency
- Keywords
- Vitamin B12, Vegetarian diet, Purple laver (Porphyra sp.), Nori
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2.4μg vitamin B12 | Experimental | Other: Dried purple laver (Nori)Participants need to consume 4 sheets (5g) of dried purple laver (Nori) daily for 4 weeks. |
| 4μg vitamin B12 | Experimental | Other: Dried purple laver (Nori)Participants need to consume 7 sheets (8g) of dried purple laver (Nori) daily for 4 weeks. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dried purple laver (Nori)Dried purple laver (Nori) that has been test to have bioactivity vitamin B12 will be given for intervention groups. | Other | 2.4μg vitamin B12, 4μg vitamin B12 |
Primary outcome
Change in holotranscobalamin in 4 weeks
Time frame: 4 weeks (Week 4 - Baseline)
Assessing the change in serum holotranscobalamin after consuming varying doses of nori
Change in methylmalonic acid in 4 weeks
Time frame: 4 weeks (Week 4 - Baseline)
Assessing the change in serum methylmalonic acid after consuming varying doses of nori
2 secondary outcomes
Change in serum vitamin B12 concentration in 4 weeks
Time frame: 4 weeks (Week 4 - Baseline)
Change in homocysteine in 4 weeks
Time frame: 4 weeks (Week 4 - Baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Background: PubMed 35399690Chiu 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.
- Background: PubMed 11430774Takenaka 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.
- Background: PubMed 8926531Suzuki 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.
- Background: PubMed 25651739Schwarz 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.
- Background: PubMed 7562085Rauma 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.
- Background: PubMed 24803097Watanabe 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.
- Background: PubMed 27916823Rizzo 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.
- Derived from this study: PubMed 39352476Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Hsueh-Ting Chiu, PhD principal investigator
Fu-Jen Catholic University, Department of Nutritional Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dried purple laver (Nori) in people with Vitamin B 12 Deficiency, run by Fu Jen Catholic University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in holotranscobalamin in 4 weeks (time frame: 4 weeks (Week 4 - Baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05614960, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.