None listed
Conditions
Brief summary
A randomized cross-over feeding study conducted in free-living healthy adults aged 18 years and older old recruited from the local Hunter region. Participants will be enrolled in an 8-week dietary intervention consisting of a 2-week run-in period (habitual/usual diet) followed by 2 x 2-week dietary intervention periods that include a 2-week washout between them. The 2-week diet periods will consist of a ‘Healthy Australian Diet’ that aligns with Australian recommendations and a ‘Typical Australian Diet’. These will be allocated in a randomized order. During the 2-week washout period the participant returns to their / usual diet). The entirety of the diet (i.e., 3 main meals and snacks per day) will be provided to participants during dietary period 1 and 2. Participants will supply their own meals and foods during the run-in and washout periods. Study participation involves completing self-administered questionnaires (e.g., food frequency, health. demographic, physical activity questionnaire); collection of biosamples (fasted blood sample, urine and faecal sample) and physical measurements such as blood pressure, arterial stiffness, anthropometry and body composition. Researchers hypothesise that distinct nutrition biomarkers will be detected that are representative of each diet phase.
Interventions
The Healthy Australian Diet (HAD) will provide foods to adequately meet the recommended servings of the 5 core food groups according to the current Australian Dietary Guidelines for adults e.g., 5.5 servings of grains/cereals; 5 servings of vegetables/legumes/beans; 2 servings of fruit; 3 servings of milk/yoghurt/cheese/alternatives and 2.5 servings of lean meats/alternatives. The diet aims to meet the Acceptable Macronutrient Distribution Ranges (AMDR) e.g., 15-25% energy from protein, 45-65% energy from carbohydrates, 20-35% energy from fat; less than or equal to 10% energy from saturated fat and less than or equal to 1% energy from trans fat. Some emphasis will be given to specific nutrient targets such as fibre, free sugars, and sodium. Fruits and vegetables that are rich in beta-carotene (e.g., carrots, pumpkin, tomatoes, red capsicum, and sweet potato) will be emphasized during this dietary pattern. Characteristics of the food choices will reflect a high diet quality consistent with recommendations in the Australian Dietary Guidelines. All meals and snacks are provided to participants for the duration of both 2-week diet intervention phases. This includes pre-prepared main meals (e.g., ready made fresh meals or frozen meals), fresh produce, cereals and snacks. Study investigators calorie-match the foods (to the participants baseline usual calorie intake) to be provided which are placed as a grocery order by the study investigators during the final appointment with the participants at the preceding phase. Participants collect the pre-ordered and pre-paid grocery items at their nearest allocated supermarket chain. The dietary intervention has been designed by and will be monitored by study coordinators who are also accredited practising dietitians. Participants are instructed to avoid consuming non-study foods, with usual beverage intake permitted accept for discretionary choice beverages. Adherence to the dietary intervention will be assessed via the following tools: • Completion of Participant Protocol Adherence Check List • Three 24-hour food recalls per intervention phase as well as during run-in and washout to monitor dietary intake • Daily record keeping of consumption of tea, coffee, and alcohol (using Easy Diet Diary app) • Record keeping of any food consumed out of the home e.g., takeaway, restaurant / café foods and/or any non-study foods (using Easy Diet Diary app) • Completion of Australian Eating Survey surveys at the end of each diet phase • Attend two virtual study check-ins where investigators answer any questions to ensure participants adhere to protocol • Measurement plasma metabolites for respective indicator foods during each diet phase will be used as dietary biomarkers to objectively assess compliance to diet protocol After completion of each dietary intervention phase, participants undergo a 2-week washout period where they return to their usual food habits, eating their own food (i.e., no food is supplied during the washout period). Upon enrolment, consent participants commence a 2-week run-in period prior to their first diet allocation. During the run-in period where they continue to consume their habitual diet (note, food is not supplied by study investigators for the run-in period). The run-in period includes collection of baseline data: social, medial, physical and demographic; bio-sampling (blood, plasma, urine, faecal), anthropometry, usual dietary intake and determine study adherence (i.e., attending appointments and completing various data collection measurements as outlined in the participant information sheet they would have consented to).
Sponsors
Study design
Eligibility
Inclusion criteria
• Healthy adults (aged 18 years and older) • Currently taking no medications or are on stable medication therapy for the last 3 months • Willing to adhere to strict diet protocol for 8 weeks • Access to a smart phone or tablet with access to the internet • In the Newcastle region for at least the entirety of the two feeding intervention periods
Exclusion criteria
Volunteers will be excluded if they have/are: • Food allergies or intolerances • Uncontrolled hypertension as defined by the National Heart Foundation of Australia (systolic blood pressure greater than or equal to 180 and/or diastolic blood pressure greater than or equal to 110) • Type 1 diabetes or insulin-dependent Type 2 diabetes • Cancer receiving treatment • Following strict diet regimen e.g., vegan, intermittent fasting • Noncompliant during run in stage • Individuals who have lost or gained greater than or equal to 5% body weight in the past 2 months • History of gastric ulcers, gastrointestinal disorders including severe digestive disorders such as irritable bowel syndrome • On medication known to influence study outcomes e.g. antibiotics, probiotics or prebiotics, hormone therapy, anti-inflammatory medications, corticosteroids, medications affecting metabolism • Routinely taking any supplements known to influence the study outcomes e.g. fish oils • On unstable medication regimens • Currently participating in another research intervention trial involving dietary intervention and/or physical activity intervention • Chronic or excessive alcohol consumption as per NHMRC Guidelines to Reduce Health Risks from Drinking Alcohol (greater than 10 standard drinks per week) • Pregnant or breastfeeding