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