Nutrition & Metabolism, 4 (1), 24
"We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data." FDA noted that two of the nine randomized subjects who received the investigational product were not eligible under the enrollment criteria
Additional at-risk groups include: Vegans and strict vegetarians , who may have low dietary B12 intake People with autoimmune conditions , including pernicious anaemia or type 1 diabetes Individuals with gastrointestinal conditions such as Crohn's disease or coeliac disease, which impair nutrient absorption People who have undergone bariatric surgery , which can significantly reduce B12 absorption Long-term users of proton pump inhibitors (PPIs) or H2-receptor antagonists , which reduce gastric acid and impair B12 release from food Those with a family history of either pernicious anaemia or diabetes For these groups, simultaneous monitoring of B12 status and glycaemic markers is particularly important to avoid diagnostic errors
Individual variation in NNMT expression NNMT expression varies significantly between individuals
A., Horner, J
