Polyphenol Enriched Extra-virgin Olive Oil and Postprandial Glucose Response in Patients With Type 1 Diabetes: Possible Effects and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- the between-group difference in postprandial glycemia changes after the dietary interventions
研究概览
简要总结
The aims of this study are to investigate the short term effects of MUFA alone vs. MUFA plus Polyphenols contained in the extra-virgin olive oil (EVOO) on the postprandial glycemic response in patients with type 1 diabetes and to explore the possible mechanisms through which MUFA alone or MUFA plus Polyphenols contained in EVOO could influence postprandial glycaemia.The intervention will be preceded by two-weeks run-in period during which participants will consume an usual olive oil, fill-in a 7-day dietary food record and practice continuous blood glucose monitoring (CGM) in order to optimize basal insulin infusion values and the insulin-to-glycemic load ratio.The study will be conducted according to a randomized cross-over design.
The participants will consume, in random order at a distance of one week from each other, a meal-test seasoned with extra virgin olive oil rich in polyphenols (EVOO + POLY) or a meal-test seasoned with olive oil poor in polyphenols (OO-POLY). Upon fasting and during the 6 hours following the meal, patients will undergo to:
- Venous blood drawing samples for the evaluation of gastrointestinal hormones, markers of systemic inflammation and oxidative stress.
- Breath test with 13C-octanoic acid, for the study of gastric emptying. During the experimental period the participants will undergo to continuous glucose monitoring wearing sensors 7 days/week.
The results of this study will allow optimizing insulin therapy based on the macronutrient composition of the meal in patients with type 1 diabetes mellitus treated with insulin pump. This will improve glycemic control and quality of life of these patients and reduce the risk of developing chronic diabetes complications.
详细描述
In a recent study the use of extra virgin olive oil (EVOO) (rich in MUFA) to a high glycemic index meal attenuated the early PGR observed when this meal were consumed with either low-fat or butter (rich in SAFA), while low glycemic index foods determined a blunted early postprandial response and a late rise of blood glucose levels, independently of type and quantity of fat added. Of relevance, the effects on PGR of dietary components known to influence postprandial blood glucose metabolism, such as polyphenols, remain completely unexplored in patients with T1D. Polyphenols are bioactive compounds with high antioxidant power highly present also in EVOO, which could have contributed to the favorable effects on PGR that the investigators observed in patients with T1D.
The aims of this study are to investigate the short term effects of MUFA alone vs. MUFA plus Polyphenols contained in EVOO on the postprandial glycemic response in patients with type 1 diabetes and to explore the possible mechanisms through which MUFA alone or MUFA plus Polyphenols contained in EVOO could influence postprandial glycaemia.
Patients with type 1 diabetes treated with continuous subcutaneous insulin infusion for at least 6 months and HbA1c less than 8.5%, will be recruited at the diabetes care unit of the Federico II University teaching hospital.
The intervention will be preceded by two-weeks run-in period during which participants will consume an usual olive oil, fill-in a 7-day dietary food record and practice continuous blood glucose monitoring (CGM) in order to optimize basal insulin infusion values and the insulin-to-glycemic load ratio.The study will be conducted according to a randomized cross-over design.
The participants will consume, in random order at a distance of one week from each other, a meal-test seasoned with extra virgin olive oil rich in polyphenols (EVOO + POLY), or a meal-test seasoned with olive oil poor in polyphenols (OO- POLY). Upon fasting and during the 6 hours following the meal, patients will undergo to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment with continuous subcutaneous insulin infusion for at least 6 months
- •HbA1c less than 8.5% (69 mmol/mol)
排除标准
- •Pregnancy and breastfeeding
- •Any other chronic or acute disease apart diabetes seriously affecting health status
研究组 & 干预措施
OO-POLY
Acute test meal
干预措施: OO-POLY (Other)
EVOO+POLY
Acute test meal
干预措施: EVOO+POLY (Other)
结局指标
主要结局
the between-group difference in postprandial glycemia changes after the dietary interventions
时间窗: 6 hours
Postprandial incremental area (iAUC)
次要结局
未报告次要终点
研究者
rivellese angela
Full Professor
Federico II University