None listed
Conditions
Brief summary
Gangliosides are compounds of fat and carbohydrate (glycolipids) that are an important component in cell membranes of most animals and humans. They are found particularly abundant in the plasma membrane of the brain and central nervous system and are recognised as having an important role in their development. Gangliosides occur naturally in our diet and are high in foods from animal origin such as dairy products, meats and eggs. Gangliosides are particularly high in human breast milk. Enhanced cognitive development in infants is seen as an area of particular interest with previous research demonstrating that feeding infants from age 2-8 weeks until 24 weeks of age with an infant formula enriched in gangliosides was associated with improved cognitive development and increased blood levels of gangliosides at the 24 week time point, relative to normal formula fed controls. The ultimate long-term goal is to optimise infant formula to replicate breast milk as closely as possible in both composition and impact on development. However, key information gaps exist regarding the bioavailability and absorption of bovine milk derived gangliosides from the gut and their impact on circulating levels of gangliosides. Addressing these gaps is the primary aim of this study. Furthermore, the validation of a finger prick dried blood spot method may provide a long lived viable alternative to venepuncture-derived blood as a vehicle for quantifying total ganglioside levels in blood samples. In parallel with finger prick blood sampling, saliva samples will be collected from participants to identify if gangliosides are a measurable entity in this fluid, derived in a minimally invasive manner. This study aims to: 1. Understand normal diurnal and day-to-day variation in ganglioside levels in healthy women of child bearing age 2. Describe the kinetics of uptake of bovine gangliosides after consuming a ganglioside-rich meal 3. Validate a finger prick dried blood spot method for measuring blood gangliosides (minimally invasive technique compared to venepuncture derived blood). Collect saliva samples in parallel with finger prick blood samples as a further minimally invasive measure of gangliosides.
Interventions
A diurnal variation study will be conducted involving the monitoring of plasma gangliosides over the course of a day and from day-to-day; a randomised controlled acute trial will investigate the kinetics of uptake in plasma of gangliosides after consumption of a high vs. a low ganglioside meal and samples collected during the acute feeding trial will be used to validate the finger prick (Guthrie card) dried blood spot gangliosides against plasma gangliosides. The study will comprise of 3 clinic visits: Visit 1: Participants (n=33, randomly selected from total sample of 66) will present at the CSIRO clinic between 7 and 9 am after an overnight fast and remain at the clinic for the next 2 hours. Participants will have an IV cannula inserted for the duration of this visit. A fasting blood sample will be collected after which participants will be provided with a high ganglioside meal (200 mL of a dairy based milk drink) . Blood samples will be collected after 1 h and 2h. Visit 2 (7 days post baseline visit): Participants will follow their habitual diet for 7 days and present at the CSIRO clinic between 7 and 9 am after an overnight fast (from 8 pm) and remain at the clinic for the next 8 hours. Participants will have an IV cannula inserted for the duration of this visit. A fasting blood sample will be collected after which participants will be provided with a high ganglioside meal (200 mL of a dairy based milk drink). For the remainder of the day the participants will remain in the clinic and consume low ganglioside snacks/meals (breakfast - 8 am, lunch – 12.30 pm as well as mid-morning -10 am and mid-afternoon snacks -2.30 pm, times at which meals/snacks are consumed may vary by 30 minutes to that listed to accommodate staggering of blood sampling from all study participants). Low ganglioside meals consumed throughout the day will consist of fruit and nut snacks and a choice from Pumpkin soup, Fettuccine with Garlic, Tomatoes & Olives, Fragrant Vegetable Curry or Vegan Fried Rice as main meals. Blood samples will be collected after 1h, 2h, 4h, 6h and 8h. Fasting samples from this visit will be compared to fasting samples from visit 3 to see how ganglioside concentrations change after following a low ganglioside diet for 1 week. Visit 3 (14 days post baseline visit): The acute ganglioside intervention will be conducted using a randomised parallel study design. During the week preceding the test day participants will be requested to consume a low ganglioside diet (vegan diet, since gangliosides are only found in animal-derived foods). Dietitians will specifically design this dietary pattern and counsel the participants through this eating pattern. Participants will be provided with approximately 30 % of foods/vouchers and a shopping list to enhance compliance. Compliance to the diets will be assessed through a compliance checklist which will require participants to indicate if they consumed any “disallowed foods”. Participants will be asked to check yes/no against a range of food categories e.g. milk, cheese, meat etc. In the instance of consumption of any “disallowed foods” the participant will be asked to provide details about the type/amount of food/s consumed. This compliance checklist will be reviewed by the dietitian at visit 3. On the test day participants will be fasted from 8 pm the previous night, presenting at the CSIRO clinic between 7 and 9 am and remain at the clinic for the next 8 hours. Participants will be randomly assigned to treatments including consumption of a high ganglioside meal (200 mL of a dairy based milk drink) or a low ganglioside meal (200 mL of a Soy milk drink) Participants will have IV cannula inserted for the duration of the visit. A fasting blood sample will be collected after which participants will consume the test meal within 15 minutes. Blood samples will be collected after 0.5h, 1h, 2h, 4h, 6h, 8h. During the day participants will consume low ganglioside, low fat snacks and meals as described for visit 2 of the study. The high ganglioside intervention will consist of bovine milk with added gangliosides in powder form to deliver 80 mg gangliosides per meal (200 mL in total volume). The low ganglioside intervention will consist of non-bovine flavoured milk devoid of gangliosides. Soy milk is the most nutritionally comparable to bovine milk (200 mL in total volume to also be consumed). Participants will be requested to maintain their habitual lifestyle patterns for the duration of the study unless otherwise specified.
Sponsors
Study design
Eligibility
Inclusion criteria
• Healthy females aged 18 – 40 years • BMI 18.5 – 30 kg/m2
Exclusion criteria
• Known history or presence of chronic disease – cancer, type 2 diabetes, heart disease, gastrointestinal disease, renal or hepatic disease, pancreatic insufficiency, stomach ulcers, drug abuse or alcoholism, thyroid disorders or any condition that may, in the opinion of the principle investigator, influence the study outcomes • Any medical procedures deemed by the principal investigator to affect study outcomes • Known food allergies, hypersensitivity, dietary avoidance or intolerance to the study foods • Taking medications known to influence lipid metabolism, glucose tolerance and gastric emptying (oral contraceptives are accepted) • Sufferer of bleeding disorders • Self-reported pregnancy or breastfeeding • Persons considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol. • Participation in another research study within 30 days preceding the start of this study