WP3. In vivo kinetics assessment of insoluble DF fermentation related to health: FiberTAG intervention studies (P1,P2 leader,P5,P6; M1-M33)

Task 3.1 BRAN pilot study: Metabolic signature of wheat bran related to gut fermentation in humans

3.1.1. 13C-wheat bran prototype development

3.1.2. 13C-wheat bran prototype characterization.

3.1.3. In vivo pilot study to evaluate the extent and the metabolic signature of the insoluble DF bran fermentation in human healthy volunteers using 13C-wheat bran.

Task 3.2. CHITIN-GLUCAN intervention studies

3.2.1. Development of new formulations of chitin-glucan

3.2.2. Evaluation of fermentability of chitin-glucan in healthy volunteers after an acute intake.

3.2.3. CHITIN-GLUCAN intervention in healthy volunteers: effect of the chronic intake on gut microbiota composition and function.

3.2.4. CHITIN-GLUCAN intervention in cardiometabolic risk volunteers: relevance of chitin-glucan fermentation on cardio-metabolic risk factors

Deliverables (D) and Milestones (M) of WP3 with delivery date

D3.1  13C-wheat bran prototypes for intervention (M3)

D3.2  characterization of 13C-wheat bran prototype (M24)

D3.3  batches of chitin-glucan and placebo for interventions (M6)

D3.4  new formulations of chitin-glucan (M30)

D3.5  characterization of new formulations of chitin-glucan (M30)

D3.6  ethical committee agreements and informed consents (M9)

D3.7  SOPs for sample collection for intervention studies (M6)

D3.8  reports on metabolic signature of chitin-glucan related to gut fermentation (M24)

D3.9   reports on physiological outcomes and related biomarkers of chitin-glucan (M33)

M3.1 granting of all regulatory approvals (M12)

M3.2 date of the recruitment of the first volunteers (M4)

Risk: Problem in manufacture of the wheat bran prototype. Mitigation measure: Change in the proportion of 13C- 12C isotopes in the wheat fraction.

Risk: Difficulties to recruit test subjects. Mitigation measure: Best practice in communication and selection of appropriate channels

Risk: Difficulties to get ethical authorization. Mitigation measure: Teams applying for approval are highly experienced + excellent knowledge of regulation and submission process

Risk: Drop-out from clinical studies. Mitigation measure: Large number of screened test subjects to maintain power