Effect of Ginger Extract on Postprandial Glycemia of Healthy Adults and Its Antioxidant Properties: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incremental area under the curve of glucose levels
研究概览
简要总结
Background: Hyperglycemia is a risk factor to disease development, namely, diabetes mellitus. The blood glucose level management, particularly on post-prandial period has an important role in the prevention of different diseases. Ginger is a specie that has been demonstrated a benefit effect on glycaemia on diabetes.
Aim: The aim of this study was 1) to investigate the effects of ginger infusion in the glycaemic response in nondiabetic adults; 2) to evaluate total phenolic content the antioxidant activity of Ginger (Zingiber officinale Roscoe) aqueous extracts.
Methodology: 24 nondiabetic subjects were randomly allocated into two groups: intervention group (GI; n=15) and control group (GC; n=15). An oral glucose solution (OGTT) and an OGTT following ginger extract solution were administrated in control and intervention groups, respectively. Blood glucose levels were measurement at fasting and after 30, 60, 90 and 120 minutes after interventions in both groups. Total phenolic content and flavonoids compounds determination of the aqueous ginger extract was determined according to Prabha method. Antioxidant activity was also measured through ABTS method and free radicals inhibition capacity. Repeated Measures ANOVA of mixed type and independent samples t-test were used in statistical analysis.
详细描述
This clinical trial was approved by Ethical Committee (process number 519 at 23 November 2016). All participants signed a written informed consent after aim and experimental risk procedures explanation and its protected confidentiality was guaranteed. The experimental procedure involving human was care out according Declaration of Helsinki.
This blind (to participants) randomized controlled clinical trial was conducted at Egas Moniz higher education school in 30 nondiabetic adults. Participants with ages between 18 and 40 were selected and randomly allocated in intervention group (IG) (n=15) and control group (CG) (n=15), in which participants were alternated include in the groups. The IG performed an oral glucose tolerance test (OGTT) followed by aqueous ginger extract administration and the CG performed an OGTT administration alone.
For ginger extract preparation, powder ginger (Zingibre officinalle Roscoe) was obtained from Portugal Company with India origin and stored in a dried environmental locally until needed. The product has a batch number of LI1GIGRNT150012. Powder ginger was individually weight (0.2g each dose) and added to 100mL of boiled water obtaining the ginger extract, infusing 10 minutes. Ginger extract solution was after cooled at room temperature and distributed to each participant. This method was adapted by Wilkinson, J. M. (2000). For chemical analysis, a aqueous ginger extract previously obtained was used.
Regarding to blood glucose level assessment, the blood sample were collected for each participant using a capillary drop blood before the intervention (fasting) and after 30, 60, 90 and 120 minutes. The blood glucose level analysis was performed using a strips for glucose meter (Onetouch Select Plus Flex), a sterilized lancet and a glucose meter equipment.
General characteristics data of the participants were collected, namely, anthropometrics data, pharmacologic treatment and medical condition using a questionnaire. In addition, a 24-hour dietary recall at the day before the intervention was employing to sample participants. The nutritional analyzed of diet ingested was performed by Food Processor SQL (version 10.5.0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects without glucose metabolism alteration
排除标准
- •medication for glycemia
- •had gastrointestinal symptoms or disease
- •pregnancy or lactation
- •had allergy to ginger.
- •to ingest ginger at the day before the intervention.
结局指标
主要结局
Incremental area under the curve of glucose levels
时间窗: At 120 minutes after intervention
the blood glucose incremental area under the curve (AUCi) of each participant was defined using the GraphPad Prism program (version 5.0).
Antioxidant activity determination of Ginger extract
时间窗: At baseline
Mean values of anion and radical inhibition capacity and mean values of antioxidant capacity by ABTS (micromol TE/g)
Flavonoids
时间窗: At baseline
Mean values of flavonoids (mg quercetin of/g ginger)
Blood glucose maximum concentrations
时间窗: At 60 minutos after intervention
Mean blood glucose levels (mmol/L)
Total phenolic compounds
时间窗: At baseline
Mean values of total phenolic compounds (mg of gallic acid/g ginger)
Postprandial blood glucose levels time curve
时间窗: up to 120 minutes after intervention
Mean blood glucose levels (mmol/L) obtained after oral glucose tolerance test in control group and after oral glucose tolerance test plus baobab extract in intervention group at different moments
次要结局
- Body mass index of participants(At baseline)
- Weight of participants(At baseline)
- Height of participants(At baseline)