Trial Details

Not Recruiting
Basic Information
Clinical ID c2647
Identifier ACTRN12619000845134
Trial Title Exploring the use of a high-fibre diet to alter short-chain fatty acids and immune markers in healthy humans: A pilot study
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Gut disease;Asthma;Inflammatory Bowel Disease;Allergies; Gut disease Asthma Inflammatory Bowel Disease Allergies;Diet and Nutrition - Other diet and nutrition disorders;Inflammatory and Immune System - Normal development and function of the immune system;Metabolic and Endocrine - Normal metabolism and endocrine development and function;Oral and Gastrointestinal - Inflammatory bowel disease
Interventions The study has a cross-over design in which participants are randomised to complete a intervention diet and control diet in random order. The intervention diet is a 5-day high-fibre dietary intervention provided in the form of meals to study participants. Participants are provided with 3 main meals day (breakfast, lunch, dinner) and 2 snack items a day (morning tea, afternoon tea). Participants may also eat other foods outside of the provided diet but are given a list of recommended snack foods to help them follow the intervention diet as best as possible. Meals have been developed with a dietitian to ensure they are nutritionally balanced and are cooked by a research chef in a commercial grade kitchen. Meals are portioned, vacuum-sealed and then provided to participants frozen. Participants are given study food diaries to follow and to help assess compliance. The average amount of energy provided by the study meals/snacks is 9277 kj/day. The average amount of total fibre is 39 g/day all of which is naturally contained in the foods provided. These are mainly in the form of resistant starch (7 g/day) and fermentable oligosaccharides (7 g/day). Meals for the high fibre diet high in legumes, wholegrains, fruits and vegetables. Example foods include Rye bread, wholegrain cereals (wheat bran), brown rice, split peas, pear and cannellini beans. These figures have been calculated through the use of food composition software (Foodworks). Once completed, there is a 5-day wash-out period between the diets.
Participant Information
Sponsor Monash University
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, OLDER_ADULT
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date 2019-06-14
Completion Date 2015-09-10