"Prebiotics and Diet to Reduce Leaky Gut in First Degree Relatives of Crohn's Disease Patients"

NACompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

February 4, 2020

Primary Completion Date

January 8, 2024

Study Completion Date

May 17, 2024

Conditions
Healthy First Degree Relatives of Crohn's Disease Patients
Interventions
DIETARY_SUPPLEMENT

Prebiotics

Oligofructose-enriched inulin \[a combination of shorter chain oligofructose, Degree of Polymerisation (DP) 3 - 9 and longer chain inulin (DP ≥ 10), in a 50:50 ratio ± 10 %\] 12 g/day for 6 weeks

OTHER

Low n-6 PUFA Diet

The Mediterranean diet pattern (MDP) with increased n-3 PUFA, saturated fatty acids (SFA) and monounsaturated fatty acids (MUFA) and reduced n-6 PUFAs food intake will be adopted as suitable Low n-6 PUFA diet.

DIETARY_SUPPLEMENT

Maltodextrin

Maltodextrin consists of D-glucose units connected in chains of variable length (DP 3-17). The glucose units are primarily linked with α(1→4) glycosidic bonds. Maltodextrin is easily hydrolyzed by the intestinal enzymes and thus does not have an effect on colonic microbiota. Maltodextrin (5 g/days for 6 weeks) will be used as a placebo for the prebiotic treatment

OTHER

Control Diet

"Participants who will not be assigned to Low n-6 PUFA diet will be advised to follow the Canada's Food Guide recommendations (Control diet). As Canada's Food Guide Diet is also designed with the aim to support healthy eating and prevention of metabolic and chronic disorders, this diet may not be considered as a true comparator for the Low n-6 PUFA diet intervention."

Trial Locations (1)

T6G 2E1

University of Alberta, Edmonton

All Listed Sponsors
lead

University of Alberta

OTHER

NCT03950336 - "Prebiotics and Diet to Reduce Leaky Gut in First Degree Relatives of Crohn's Disease Patients" | Biotech Hunter | Biotech Hunter