About this trial

This randomized, double-blind, crossover trial (Phase IV) aims to compare the absorption of a novel permeability-enhanced oral vitamin B12 formulation (Ampli-B) versus standard oral vitamin B12 in 12 healthy adults aged 50 years and older. Each participant receives a single dose of each formulation in randomized sequence, separated by a minimum 10-day washout. The primary outcome is time to peak serum concentration (Tmax) of total and active vitamin B12 (holotranscobalamin). Secondary outcomes include Cmax and AUC parameters.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males and females 50 years of age and older

BMI between 18 to 29.9 kg/m2

Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,

Sexual abstinence.

Disqualifiers

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study

Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational products

History or current diagnosis of any clinically significant disease that may alter vitamin B12 absorption, accumulation, metabolism or excretion

Taking vitamin B12 supplements or a multivitamin supplement containing vitamin B12 within the prior 2 months from study product administration.

Trial design

Design model

Crossover

Treatments tested in this trial

Ampli-B
Dietary supplement
Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.
Vitamin B12
Dietary supplement
Participants will receive a single capsule containing 1mg vitamin B12 .

Treatment groups

12 Participants

are divided into 2 treatment groups

Group A: Ampli-BExperimental treatment 1 intervention

Group B: Standard B12Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Tmax of total vitamin b12 and holoTC between AmpliB and standard vitamin B12.

Comparison of the time to peak maximum concentration (tmax) of total serum cyanocobalamin (total vitamin B12) and active cyanocobalamin \[holotranscobalamin (holoTC)\] between AmpliB and standard vitamin B12.

Time frame

Day 1 to 24hrs post Visit 3 (visit 4/day 11)

Secondary outcomes

1

Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 Cmax

Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters: • The maximum concentration (Cmax)

Time frame