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

Study of immune and therapeutic effects of short-chain fatty acids in humans given a high fibre diet.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001054202
Acronym
SITES
Enrollment
22
Registered
2018-06-25
Start date
2018-08-23
Completion date
2019-06-25
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Dietary fibre is important for gut health. Within the large intestine, some dietary fibres are broken down by the gut bacteria (microbiota) in a process called fermentation. A product of fermentation are metabolites called short-chain fatty acids. These can also be found in fermented foods and drinks, such as vinegar. In animal studies, short-chain fatty acids have been associated with reduced inflammation and lower blood pressure. The aims of this research project is to investigate if increasing short-chain fatty acids through increasing fibre and fermentable foods in the diet have effects on: 1. Immune cells and inflammation 2. Blood pressure 3. Gut function To answer these questions, we are asking for healthy volunteers to participate in a dietary intervention study. This will involve consuming a diet with varying levels of fibre and fermented foods. At certain points in the study, Blood and faecal samples will be taken and we will also measure your blood pressure. We aim to recruit 30 healthy participants. This study will help us to understand if dietary fibre and fermentable foods could be used to reduce inflammation and blood pressure in conditions such as asthma, allergy and hypertension in the future. This study has been initiated by A/Prof. Jane Muir, head of Translational research at the Department of Gastroenterology and is being conducted by Mr. Paul Gill as part of his PhD studies

Interventions

3 week dietary intervention provided in the form of meals and supplements 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 coo

3 week dietary intervention provided in the form of meals and supplements 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 8400 kj/day as to ensure all intervention meals are consumed. The average amount of fibre is 40 g/day. 20 g of which is from the foods provided, 10 g from Resistant starch added to certain meals and 10 g from Inulin also added to certain meals. These fibres are mixed into meals during the cooking process. These figures have been calculated through the use of food composition software (Foodworks). Examples of meals that have resistant starch fibre added to them include breakfast pancakes, muffins and Tuna and vegetable patties. Some meals will also have a fermentable fibre (inulin) added to them such as risotto, pasta sauce and curry.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026