Fibre supplementation and gut health in healthy females

Not Applicable

• Conditions: Gut microbiota; Immune system - Peripheral blood mononuclear cells; Inflammatory and Immune System - Normal development and function of the immune system; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12617001139369
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-04
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Healthy females, 35-65 years, BMI 18-25kg/m2

Exclusion Criteria

Exclusion criteria will include pregnancy or planning pregnancy, breastfeeding, known diabetes, known unstable or untreated blood pressure or cholesterol, cardiovascular disease, chronic inflammatory conditions, medications that may interfere with metabolism, smoking, alcohol consumption above current NHMRC guidelines, allergy or intolerance to foods, irregular eating patterns or eating disorder, following a weight reducing diet, use of antibiotics 4 weeks prior to the start of the study and during the study. Individuals taking anti-inflammatory drugs will also be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiome will be assessed from bacterial DNA extracted from stool sample. [Participants will be asked to collect one stool sample in the 2 days before each supplementation period and in the last 2 days of each supplementation period.];Fasting serum levels of short chain fatty acids.[Fasted serum samples will be collected prior to supplementation on day 1 of each supplementation period and the day following each 7-day supplementation period. ];Fasting plasma immune cell populations.[Fasted plasma samples will be collected prior to supplementation on day 1 of each supplementation period and the day following each 7-day supplementation period. ]

Secondary Outcome Measures

Name	Time	Method
Habitual diet[Participants will be asked to keep a 6 x 4 day food diaries to record their dietary intake 4 days prior to and during the last 4 days of each 7 day fibre supplementation period. ]