None listed
Conditions
Brief summary
Type 2 diabetes is increasing worldwide and can cause serious health complications if left uncontrolled. In 2014 it was estimated that 9% of the global adult population suffered from diabetes, of which 90% could be attributed to type 2 diabetes. Optimal blood glucose control reduces the risk of diabetes-related complications. There are currently a number of drugs on the market to control blood sugar levels; however they produce unpleasant side effects. Marine polyphenols have shown potential to improve blood glucose control without producing side effects. While polyphenols are found in both terrestrial plants and marine algae, this study will focus solely on those commercially available from marine sources. Marine polyphenols, or phlorotannins, are most commonly found in brown algae. There are a number of advantages to cultivating marine algae compared with terrestrial plants, and marine-derived compounds are rapidly growing in popularity in the food industry, especially with the current consumer preference for natural health products over synthetic ones. There is promising research regarding the antidiabetic effects of marine polyphenols in animal and in vitro studies. However, it is yet to be determined if the same health effects are consistently true in a human population. If so, marine polyphenols may be useful for controlling blood sugar levels, resulting in fewer side effects and a reduced risk of complications for people with type 2 diabetes. Marine polyphenols may also be useful for people with prediabetes to lower blood sugar levels and prevent progression to type 2 diabetes. This study aims to: 1. Determine the effect of commercially available doses of marine polyphenols in supplement form on postprandial blood glucose and insulin following a glucose load, compared to placebo in a human population. 2. Determine how well different doses of polyphenols are accepted through completion of an intolerance symptoms questionnaire. 3. Examine the effects of commercially available doses (Marinova) of marine polyphenols in supplement form on changes in blood glucose and insulin following a glucose load, in the evening. Blood glucose rises higher and stays high for longer following consumption of carbohydrates in the evening, compared to the morning.
Interventions
The test product is Maritech (Registered Trademark) Synergy, an extract from the macroagla Fucus vesiculosus that contains 30% polyphenols and 60% fucoidan (a complex carbohydrate). The product will be encapsulated for ease of consumption and dosing. Doses of 500 mg (150 mg polyphenols) and 2000 mg (600 mg polyphenols) will be administered on a single occasion prior to an oral glucose tolerance test.
Participants will be provided with a standardised commercially available frozen meal to consum
The test product is Maritech (Registered Trademark) Synergy, an extract from the macroagla Fucus vesiculosus that contains 30% polyphenols and 60% fucoidan (a complex carbohydrate). The product will be encapsulated for ease of consumption and dosing. Doses of 500 mg (150 mg polyphenols) and 2000 mg (600 mg polyphenols) will be administered on a single occasion prior to an oral glucose tolerance test. Participants will be provided with a standardised commercially available frozen meal to consume between 7 - 9 pm the night before each testing day, then will be asked to fast until testing is complete, drinking only water. Participants are also asked to avoid foods high in polyphenols and strenuous exercise for 24 hours prior to testing. Participants will be asked to come in to the lab at 7 am in the morning following an overnight fast. They will have two initial finger prick tests done to provide fasting levels of blood glucose and insulin (at -45 and -30 minutes), then be given either a low (500 mg) or high (2000 mg) dose of marine polyhpenol supplement. At 0 minutes they will be provided with a 50 g available carbohydrates from bread, which must be consumed within 5 minutes. Following completion of the three morning cross overs (high dose, low dose, placebo), all participants will have the option to continue to partake in the evening arm of the study. Participants who choose to complete the evening protocol as well will have a wash out period between the two arms of at least 3 days. Participants will be randomized as to the order they will consume the placebo and 2000 mg dose of the test product, in a 2-way cross-over. The same protocol as for the mornings will be carried out for evening testing, but with participants consuming a standardised commercially available frozen meal between 7 and 8 am and arriving at the testing facility at 6 pm after fasting throughout the day. Participants will consume the test doses and placebo in a cross-over fashion with at least three days washout in between each treatment. All treatment doses will be administered and supervised on site.
Sponsors
Monash University, Department of Nutrition and Dietetics
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Body mass index from 18.5 to less than 28 kg/m2, a fasting blood glucose level below 5.5 mmol/L and blood pressure within the normal range.
Exclusion criteria
1. Gastrointestinal issues that may affect the absorption and intestinal actions of the polyphenols, 2. Taking medication for blood sugar control, 3. Taking other natural health products known to impact on polyphenols e.g. fish oil, 4. Breastfeeding or pregnant, 5. Have any of the following serious health conditions: i. liver/thyroid issues, ii. hypertension, iii. recent major surgery, 6. Consume more than 4 standard drinks per day, or 9 standard drinks per week, 7. Smoker, 8. Have an implanted cardiac defibrillator.
Outcome results
None listed