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Completed

NCT Number: NCT05614960

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

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

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Key information

Conditions

Vitamin B 12 Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B Deficiency

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutritional Science, Fu-Jen Catholic University

New Taipei City, 24205, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dried purple laver (Nori)

Other

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Change in serum vitamin B12 concentration in 4 weeks

    Time frame: 4 weeks (Week 4 - Baseline)

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

  2. Change in homocysteine in 4 weeks

    Time frame: 4 weeks (Week 4 - Baseline)

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

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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