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临床试验/NCT06096298
NCT06096298尚未招募不适用

Bioavailability of Vitamin B12 in Bread Using Fermented Faba Bean as B12 Source in Healthy Volunteers (BeanBread)

University of Helsinki0 个研究点目标入组 25 人开始时间: 2023年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
主要终点
Vitamin B12 bound to transcobalamin II (holoTc)

研究概览

简要总结

Vitamin B12 is naturally present in animal products, but it could be added to plant-based products through fermentation using the Propionibacterium freudenreichii bacterium. This study aims to investigate the absorption of vitamin B12 synthesized by Propionibacterium freudenreichii from products made with fermented faba bean. The study products are wheat breads of which 30 % of the dry weight has been replaced with fermented faba bean flour. One of the study breads contains vitamin B12 produced by P. freudenreichii bacteria, and the other bread (control bread) is fermented using L. brevis bacteria (does not produce vitamin B12). The participants will eat the study bread for two consecutive days during the study weeks, with a washout period of 12 days. Fasting blood samples are collected on day 1 before administration of the first dose of vitamin B12 and on day 3. Nutrient intake and food consumption will be analyzed from 3-day food records at the baseline and on the bread eating days. The study is carried out in a double-blinded crossover setting.

详细描述

A human intervention study with healthy volunteers will be carried out to investigate the absorption of vitamin B12 synthesized by Propionibacterium freudenreichii from bread made with fermented faba bean. The study is conducted on healthy, 18-50-year-old volunteers. The study is carried out in a randomized, double-blinded, placebo-controlled crossover design.

The study products are wheat breads of which 30% of the dry weight has been replaced with fermented faba bean flour. One of the study breads contains fermented faba bean flour containing vitamin B12 produced by P. freudenreichii bacteria, and the other bread (control bread) contains faba bean flour fermented with L. brevis bacteria (does not produce vitamin B12). In addition to the study breads, the study participants are given a vitamin supplement containing cyanocobalamin as a positive control during one study week and a placebo supplement as a negative control for two weeks. During each study period, the subjects eat study breads and supplements for two consecutive days, three times a day. The study participants are otherwise allowed to follow their usual diet. On the morning of the first and third study day of each study period, a blood sample is taken from the subjects, from which the vitamin B12 bound to holotranscobalamin II and the total vitamin B12 concentration in the serum are determined. At the baseline of the study, the blood samples are also analyzed for folate, methylmalonate, homocysteine and creatinine concentrations.

Nutrient intake and food consumption will be analyzed from 3-day food records during the run-in week and each study week (total 9 days). The participants will report their gastrointestinal symptoms during the study periods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

The study is double-masked - neither the researchers or the participants know which bread they are eating.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index between 18.5 and 35 kg/m2
  • No exclusion criteria listed below

排除标准

  • Food allergies against ingredients in foods supplemented in the study
  • pregnancy and/or breastfeeding
  • Regular use of food supplements containg B12
  • Blood donation within 3 months
  • Alcohol consumption more than 24 measures per week
  • Smoking, using snuff
  • Iron, B12 or folate deficiency
  • small intestinal bacterial overgrowth (SIBO)
  • Gastritis
  • Helicobacter pylori infection
  • Acid reflux
  • Chron's disease
  • Celiac disease
  • Pancreatitis
  • Abdominal surgery
  • Eating disorder
  • Use of supplements containing vitamin B12 in the last year
  • Vitamin B12 injection treatment in the last year
  • Use of metformin, protein pump inhibitors or H2-receptor blockers

结局指标

主要结局

Vitamin B12 bound to transcobalamin II (holoTc)

时间窗: 2 days

Changes in serum holotranscobalamin concentrations after intake of vitamin B12

Total B12

时间窗: 2 days

Changes in serum total B12 concentrations after intake of vitamin B12

次要结局

  • The intensity of gastrointestinal symptoms measured by a visual analogue scale(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne-Maria Pajari

Associate Professor

University of Helsinki

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