None listed
Conditions
Brief summary
People with prediabetes (an intermediate state of hyperglycaemia diagnosed by glycated haemoglobin (HbA1c) range of 41 – 49 mmol/mol) are at high-risk of developing type 2 diabetes mellitus (T2DM). Currently, the estimated conversion rate of prediabetes to T2DM is 5-10% annually. Food-based antioxidants are being investigated for their ability to be able to modulate blood glucose levels. A recent study has shown that 4 antioxidant-rich food extracts (Amla berry-, Grape seed-,Rooibos tea- and Green tea- extracts) significantly decreased the postprandial blood glucose response in healthy subjects response by 25-40% compared to a glucose-control (all p < 0.05). Little is known about whether these food supplements/extracts can be used to improve glycaemic control in persons with prediabetes Hyperglycaemia and insulin resistance are the main pathophysiological changes behind the development of prediabetes and T2DM. Prediabetes has been recognised as being the key period during which interventions may lead to a slowing or a prevention of development of T2DM. This proposed study will initiate investigations into the use of antioxidant-rich food extracts as an intervention for reducing postprandial hyperglycaemia in people with prediabetes and reducing progression of prediabetes to T2DM. Overall Aim of this Study: To examine the acute effects of specific antioxidant-rich food extracts (rooibos tea, amla berry, olive leaf extract and grapeseed extract) in reducing postprandial blood glucose response in people with prediabetes. Secondary Aim of this Study: To examine the acute term effects of four antioxidant-rich food extracts on insulin response and antioxidant capacity in people with prediabetes
Interventions
The acute effect of four antioxidant-rich food extracts on postprandial blood glucose and insulin response in people with prediabetes will be investigated. The following four antioxidant-rich products will be tested in this study: Amla berry extract (Sharman Ltd, Nelson, New Zealand); Grape seed extract (NutraLife, New Zealand Ltd),; Rooibos tea extract (Rooibos Ltd, Clanwilliam, South Africa) and Olive Leaf Extract (COMVITA, NZ) Dose: For this study we will have 2.0 times the total antioxidant capacity (i.e approx 640 mg) as was performed in Chepulis et al. (2016) study. Antioxidant activity (as determined by ORAC assay) of each product used in this study, will be measured by Callaghan Innovation (Wellington, New Zealand. For the purposes of comparison a vitamin E sample (with a known effective concentration half-life (EC50) of 0.44 mg/mL) is included. EC50 values of the tests samples will be calculated as mg/mL. Each test sample will have equivalent total antioxidant activity and on a weight per weight basis the number of capsules (for 2x antioxidant capacity) consumed by the participant orally before the OGTT will be determined once antioxidant activity for the product has been assessed. The test session will include: An OGTT with placebo control capsule or antioxidant-rich food extract capsule administered 10 minutes before the glucose drink (75 g glucose in 200 mL water). Participants will be cannulated and observed over a 2 hour period with blood samples taken at T=0, 15, 45, 60, 90, and 120 minutes. The participant will be fasted (approx 10 hrs) before starting test session. A researcher and assistant will be present throughout the OGTT. All participants (recruitment of 20) will undergo 5 test sessions (placebo control and 4 antioxidant-rich food extracts. There will be a minimum of 48 hrs washout period between each test session. The full testing should take between 8-10 weeks. Between Test Sessions: All participants will be asked to keep their diet and lifestyles as constant as possible throughout the study and to refrain from engaging in any strenuous physical activity (walking is fine) or consumption of alcohol in the 24-hour period prior to each test session. Participants will also be asked to avoid the active test foods/extracts for at least seven days prior to the first test session and throughout the duration of the test period (including avoiding other teas and formulations where the extracts may be present. A list of such foods/teas and formulations will be provided to participants). Chepulis, L., Al-Aubaidy, H., Page, R. (2016) Effect of selected antioxidant food extracts on postprandial glucose responses in healthy individuals. Functional Foods in Health and Disease, 6(8): 493-505
Sponsors
Study design
Eligibility
Inclusion criteria
1.. Glycated haemoglobin (HbA1c) between 41-49 mmol/mol. 2. Body mass index (BMI) between 20-35 kg/m2 at time of screening.
Exclusion criteria
1. On any medication that has an effect on blood glucose levels. 2. Has renal or cardiac impairments 3. Has asthma or on asthma-related medication 4. Known allergies to any of the antioxidant extracts (amla berry, grapeseed, olive leaf or rooibos tea). 5. Smoker