Effects of Triacylglycerol Structure on Gut Hormones and Haemostatic Markers
Ключови думи
Резюме
Описание
Subjects aged between 30 and 60 years old (male and female) with Type 2 diabetes mellitus (T2DM) will be recruited for this study. A randomized, crossover, double-blind study design will be carried out to investigate the acute effects of high fat meals prepared using palm olein (PO), chemically interesterified palm olein (IPO) and high oleic sunflower oil (HOS) (control) on study subjects with T2DM. Study subjects will have to undergo three postprandial challenges, separated by at least one week interval. Fasting blood sample and duplicate baseline blood samples will be taken in the morning of postprandial day. After that, subjects will be asked to consume a test meal consisting a high fat muffin baked using the aforementioned oils and a milkshake within 10 minutes. After meal, venous blood samples will be taken at time-points 15, 30, 60, 90, 120 min, 3 h, 4 h, 5 h, 6 h and post-heparin plasma 5 min and 15 min for analysis. Pulse wave analysis will be conducted to evaluate central blood pressure and arterial stiffness. Meal appreciation will be assessed by utilising visual analogue scale (VAS) before eating, after eating and at each time-point.
Дати
| Последна проверка: | 09/30/2015 |
| Първо изпратено: | 07/10/2013 |
| Очаквано записване подадено: | 07/18/2013 |
| Първо публикувано: | 07/23/2013 |
| Изпратена последна актуализация: | 10/08/2015 |
| Последна актуализация публикувана: | 10/11/2015 |
| Действителна начална дата на проучването: | 08/31/2012 |
| Приблизителна дата на първично завършване: | 06/30/2013 |
| Очаквана дата на завършване на проучването: | 02/28/2014 |
Състояние или заболяване
Интервенция / лечение
Other: Dietary fat - PO
Other: Dietary fat - IPO
Other: Dietary fat - HOS
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Dietary fat - PO Native palm olein (IV56) | Other: Dietary fat - PO Test meal consists of a high fat muffin (containing 50 g native palm olein) and a cup of milkshake, to be taken as breakfast for each postprandial study day. |
| Experimental: Dietary fat - IPO Chemically interesterified palm olein (IV56) | Other: Dietary fat - IPO Test meal consists of a high fat muffin (containing 50 g chemically interesterified palm olein) and a cup of milkshake, to be taken as breakfast for each postprandial study day. |
| Experimental: Dietary fat - HOS High oleic sunflower oil | Other: Dietary fat - HOS Test meal consists of a high fat muffin (containing 50 g high oleic sunflower oil) and a cup of milkshake, to be taken as breakfast for each postprandial study day. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 30 Years Да се 30 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: 1. Mild T2DM individuals not planned for medical intervention - 7.0 mmol/L ≤ fasting glucose ≤ 11.1 mmol/L - 6.5% ≤ HbA1c ≤ 9.0% - Not using antihypertensive, lipid lowering, insulin/glucose modulating medication 2. Mild T2DM individuals currently on medical intervention - Fasting glucose ≤ 11.1 mmol/L - HbA1c ≤ 9.0% - Using antihypertensive, lipid lowering or glucose modulating medication 3. Malaysian male or female with T2DM aged between 30 to 60 years old 4. Not using insulin 5. Not having any complications of diabetes 6. No medical history of myocardial infarction, angina, thrombosis, stroke or cancer 7. Haemoglobin levels for females ≥ 11.5 gm/dl and males ≥ 12.5 gm/dl 8. Serum ferritin > 15 µg/l at commencement of study Exclusion Criteria: 1. Medical history of myocardial infarction, angina, thrombosis, stroke or cancer 2. Underweight (BMI < 18.5 kg/m²) 3. Using insulin 4. Total cholesterol > 7.0 mmol/L 5. Abnormal liver function, renal function and haematology 6. Hypersensitive towards heparin 7. Gastric or lactose intolerance 8. Smoker 9. Pregnancy and lactating 10. Taking alcohol 11. Taking alcohol 12. Haemoglobin levels for females ≤ 11.5 gm/dl and males ≤ 12.5 gm/dl 13. Serum ferritin < 15 µg/l at commencement of study |
Резултат
Първични изходни мерки
1. 6-hour postprandial changes from fasting in glucose-dependent insulinotropic polypeptide (GIP) [0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour]
Вторични изходни мерки
1. 6-hour postprandial changes from fasting in gut hormones [0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 h]
2. 6-hour postprandial changes from fasting in insulinaemic response [0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour]
3. 6-hour postprandial changes from fasting in lipaemia [0, 1, 2, 3, 4, 5, 6 hour for TAG and apoB48; 6 hour postheparin for LPL; pooled 3, 4, 5 hour for chylomicron and PFA]
4. 6-hour postprandial changes from fasting in haemostatic response [0, 2, 4, 6 hour for FVIIa, PAI-1 and D-dimer; 0, 4 hour for PWA]
5. 6-hour changes from fasting hunger rating using visual analogue scale (VAS) [0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour]
