None listed
Conditions
Brief summary
This study investigates how adults with metabolic syndrome respond to fibre-enriched meals. Participants will attend a clinic visit where standardised test meals will be consumed, followed by a home monitoring period. Blood samples and continuous glucose monitoring will be used to assess postprandial metabolic responses, including glucose and triglycerides. Additional data on diet, physical activity, and other individual characteristics will also be collected. The study aims to understand individual variability in metabolic responses to dietary fibre and to support the development of more personalised nutrition strategies.
Interventions
Brief name: Standardised fibre-enriched dietary challenge meals
The intervention for this study involves the administration of sequential fiber-enriched challenge meals (Intervention Meals) to adults with metabolic syndrome. Participants will consume these standardized meals to allow for the systematic measurement of postprandial glycaemic and triglyceride responses, specifically focusing on the monitoring of glucose and triglyceride levels. This exposure is designed to characterize individual
Brief name: Standardised fibre-enriched dietary challenge meals The intervention for this study involves the administration of sequential fiber-enriched challenge meals (Intervention Meals) to adults with metabolic syndrome. Participants will consume these standardized meals to allow for the systematic measurement of postprandial glycaemic and triglyceride responses, specifically focusing on the monitoring of glucose and triglyceride levels. This exposure is designed to characterize individual physiological variations in blood sugar and lipid metabolism following the intake of fiber-rich dietary components. During the 13-day study period, participants will consume a croissant breakfast (high-fat challenge meal) on Day 1 and Days 7–10. The croissant meal contains approximately 64 g carbohydrate, 38 g fat, and 12 g protein. A muffin breakfast (high-carbohydrate challenge meal) will be consumed on Days 2–6. The muffin meal contains approximately 75 g carbohydrate, 18 g fat, and 6 g protein. During Days 11–13, no breakfast will be provided and participants will consume their habitual breakfast without restriction. Adherence to the intervention will be assessed according to the study schedule and dietary records. To further define the exposure, the study includes a comprehensive assessment of participant characteristics that may influence these metabolic outcomes. This includes the collection of anthropometric measurements, habitual 3-day food intake, satiety via a Visual Analogue Scale (VAS), and physical activity levels. Additionally, biological profiling will be conducted through the analysis of gut microbiome 16S and metabolic SNPs (Single Nucleotide Polymorphisms). The integration of these dietary interventions and biological measurements aims to identify how demographic and individual metabolic variations—ranging from body composition and lifestyle to genetic and microbial factors—dictate the diversity of postprandial responses to fiber in a population with metabolic syndrome.
Sponsors
University of Wollongong
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults with metabolic syndrome, defined as meeting at least three of the following criteria: (1) abdominal obesity (waist circumference greater than 102 cm in men or greater than 88 cm in women); (2) elevated triglycerides (greater than or equal to 1.7 mmol/L) or treatment for elevated triglycerides; (3) reduced HDL cholesterol (less than 1.03 mmol/L in men or less than 1.29 mmol/L in women) or treatment for low HDL; (4) elevated fasting glucose (Fasting blood glucose 5.6–7.0 mmol/L); (5) hypertension (SBP greater than or equal to 130 mmHg or DBP greater than or equal to 85 mmHg) or treatment for hypertension. Participants must be able to comply with study procedures and have access to a mobile device or computer.
Exclusion criteria
- Does not have reliable access to the internet via a computer or mobile device - Not fluent in English - Current diagnosis of type 1 or type 2 diabetes, or on any diabetes medications except metformin - Inpatient treatment for a psychiatric condition within the past 6 months, or currently receiving treatment for schizophrenia or other serious psychiatric illness - Probable major depression, defined as a PHQ-8 score greater or equal to 10 - Pregnant women, planning a pregnancy in the next 24 months, given birth in the last 6 months, or currently breastfeeding - Great or equal to 30 total days of oral corticosteroid use within the last year, history of solid organ transplant, or history of stem cell transplant - Problematic use of alcohol and/or recreational drugs based on the ASSIST screening tool (score greater or equal to 27). - Self-reported or known history of an eating disorder (e.g., binging and purging) in the past 5 years - Use of weight loss medications (Qsymia, phentermine, etc.) or supplements in the last 3 months, or unwilling to abstain from taking weight loss medications or supplements during the study - History of bowel resection surgery or bariatric surgery - Participant does not have, or is unwilling to seek care from, a primary care physician at the time of enrollment - Any medical condition known to influence the etiology of MetS as judged by the study physician (e.g., uncontrolled hypothyroidism, endocrine hypertension, etc) - History of major cardiovascular illness, including a) stroke; b) myocardial infarction; c) congestive heart failure requiring hospitalization, or greater than NYHA heart failure class I; d) uncontrolled hypertension (SBP greater than 180 or DBP greater than 105); e) unstable angina; or f) other major cardiovascular illness which the site PI determines could limit ability to participate in the trial. - Behavioral/logistical barriers to trial participation or engagement, e.g., a scheduled major surgery, scheduling difficulties, travel plans, moving outside the study area - Cognitive impairment, defined by a Montreal Cognitive Assessment (MoCA) score less or equal to 25. The MoCA will be administered only when research staff suspect cognitive impairment - Visual or hearing impairment - Severe food allergies or food intolerances/preferences that preclude participation in the ELM program - Currently taking or expecting to take any of the following exclusionary medications: • Antiretroviral therapy (e.g., HAART) • Weight loss medications • Medications known to significantly influence weight or metabolic outcomes • Diabetes drugs other than metformin - Participation in any clinical trial, until at least six months following the end of the intervention phase. - Cancer treatment within the last 6 months, excluding chemoprophylaxis or treatment for non-melanoma skin cancer.
Outcome results
None listed