Studying health effects of consumption of a high fibre diet in healthy humans

Not Applicable

Completed

• Conditions: Hypertension; Gut disease; Diet and Nutrition - Other diet and nutrition disorders; Inflammatory and Immune System - Normal development and function of the immune system; Cardiovascular - Hypertension

• Registration Number: ACTRN12618001054202
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-25
• Study Completion: 2019-09-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Healthy adults

Exclusion Criteria

Existing or history of gastrointestinal or chronic inflammatory disease; recent acute illness or infection; antibiotic use within one month of study; consumption of probiotics or prebiotics within one month of study; use of medication gastrointestinal transit (e.g. laxatives or hypomotility agents); pregnant or planning pregnancy; suffering from an eating disorder; have special dietary requirements (vegetarian/vegan) or currently taking medication for hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood short-chain fatty acid level[Day 21 of dietary intervention period];Peripheral blood immune cells assessed by flow cyotmetry. Absolute numbers of the following cells will be assessed:<br>T cells: Th2, Th1, Th17, Treg subsets<br>B cells: IgA+, IgG+, IgE+<br>Innate immune cells: Dendritic cells, neutrophils, macrophages<br><br>This is a composite primary outcome.[Day 21 of dietary intervention period];Faecal microbiota composition as assessed by 16S rRNA sequencing. This is an exploratory outcome[Day 20 of dietary intervention period]

Secondary Outcome Measures

Name	Time	Method
Blood pressure, measured by a digital blood pressure monitor. [24 hours during day 20 of dietary intervention period];Gastrointestinal symptoms. Participants will complete bowel symptom diaries to assess abdominal bloating, bowel movements, urgency of bowel movements, wind and nausea. These are measured using VAS scales. Stool form will also be assessed using the bristol stool scale.<br>Together, this is a composite primary outcome.[Everyday throughout dietary intervention period]