None listed
Conditions
Brief summary
The microorganisms that live in and on us are called our microbiome and they are critical to our health and wellbeing. Dietary macronutrients (fat, protein, carbohydrates, fibre) influence the gut microbiome, which has been found to interact with several bodily systems including the digestive, immune, nervous, endocrine and cardiovascular. The purpose of this study is to determine whether the consumption of vegetable soups can lead to improvements in the gut microbiome as well as blood biomarkers for metabolic health.
Interventions
Participants will be randomised into one of two treatment arms to consume either two different placebo (Arm 1) or two different test soups (Arm 2) daily for two weeks. The serving size of each soup is 330 mL. Soups will be consumed orally in the participant’s location of preference e.g. at home or at work. Soups are manufactured in convenient single-serve packaging and sourced primarily from natural, wholefood plant-based ingredients. No preservatives, additives, flavours or colours are added to the soups. The soups are heat-treated during production and sealed in pouches to maintain food safety and quality for the life of the product. Being made from a variety of vegetables and herbs, the soups represent healthy dietary choices. The product recipes have been assessed by a qualified Dietitian (Dietitian Association of Australia accredited, DAA) for suitability for twice daily consumption for the duration of the two week study. The soup production facility is a standard commercial food production facility that is SQF Certified for HACCP-based food safety. All ingredients are standard food grade ingredients. Food safety and quality checks are conducted in accordance with requirements for product destined for retail sale. Good Manufacturing Processes (GMP) are used, in accordance with the site quality and food safety systems. After cooking and packaging in hermetically sealed containers, the products are then subjected to standard food safety and quality analysis (pH, moisture, microbiological assessment) as appropriate to the product. All quality and safety parameters need to be met for the product to be used in the trial. Packaging will be unbranded to minimise bias and include minimal information as is necessary for safety (product code, product storage instructions, allergen labelling etc). Prior to distribution to intervention subjects, the product will be stored in a manner that will ensure the product integrity and safety is maintained. The soups will be essentially suitable and legally fit for retail sale (with the addition of all mandatory retail labelling information). Soup consumption will be monitored using a secure, online management platform ("Freedcamp"), in which participants will be required to acknowledge soup consumption during the study.
Sponsors
Study design
Eligibility
Inclusion criteria
Adults of 18 to 65 years of age who consume low levels of dietary fibre.
Exclusion criteria
a. Females who report pregnancy or lactating; b. Gut-associated morbidities including irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), swallowing disorders and/or cancers; c. Gut-associated medications in last 12 weeks: antibiotics, dietary fiber, prebiotics, probiotics and/or antacids; d. Drugs that alter gut motility e.g. opiates, monoamine oxidase inhibitors, phenothiazines; e. Surgery in last 12 weeks; f. Food allergies and/or intolerances to soup ingredients e.g. FODMAPs.