Adansonia Digitata L. (Baobab Fruit) Effect on Postprandial Glycaemia in Healthy Adults: 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
- 31
- 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
Baobab fruits have been traditionally used in Africa due to its therapeutic proprieties attributed to it high polyphenol content. The aim of the study was to investigate the effect of baobab fruit on postprandial glycaemia on healthy adults and to measure its bioactive compounds and antioxidant activity. The study was conducted on 31 healthy subjects. The participants were randomly allocated in control group (oral glucose tolerance test (OGTT); n = 16) and in intervention group (OGTT followed by administration of 250 ml baobab aqueous extract (BAE); n = 15). Total phenols, proanthocyanidins, hydrolysable tannins and antioxidant activity (FRAP, DPPH, ABTS and inhibition of O2•- and NO• methods) were quantified. Repeated Measures ANOVA of mixed type and Independent samples t-test were used.
详细描述
This study was approved by Egas Moniz Cooperativa de Ensino Superior Ethics Committee (protocol code 518) and was carried out in accordance with the Declaration of Helsinki (Declaration of 1975, revised in 2000). An informed consent was given to all eligible participants, after oral and written information about the study.
This randomized controlled clinical trial, blind to subjects, was conducted with 31 subjects, recruited at the Campus Universitário Egas Moniz, in Monte de Caparica, Portugal. After eligibility criteria and inform consent signed, participants were subjected to the inclusion and exclusion criteria and subsequently randomly allocated in to control or intervention groups. The method of allocation sequence was based on sequentially numbers. The first patient was randomly assigned to intervention or control group, and the following patients were sequentially allocated alternately to each group. A codification was attributed to each participant in order to maintained anonymity and ensure confidentiality of data.
After a period of 8-10 hours fasting, the control group was given OGTT and the intervention group was given OGTT followed by baobab aqueous extract.
Baobab aqueous extract preparation:
The baobab fruit was bought in the market of Benfica, located in the city of Luanda (Angola) and brought to Lisbon (Portugal) duly packed in a plastic bag and stored in a dried environmental local until needed. For the aqueous extraction of the fruit 40 ± 1 g of pulp, seeds and red filaments were weighed and the fruit was boiled in 300 ml of water for 5 minutes. After slowly cooling until room temperature, extract was then placed in a refrigerator in a container where it remained for 8 hours at an average temperature of 10°C. The BAE was sieved with the aid of a net sieve, separating it from the seeds and filaments, and was subsequently subjected to the clinical trial and the antioxidant assays. For the antioxidant assays, after filtration, the extract was passed through the blender (Kenwood Multipro Compact Food Processor FDP302SI), filtered again obtaining homogeneous samples, avoiding the formation of precipitates during the analysis. Final concentration of the aqueous extract obtained, for both clinical trial and chemical analysis, was 0.1333 g Adansonia digitata L. (AD) / ml extract fresh weight (FW).
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
- Double (Participant, Investigator)
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
- •Not currently undergoing lactation or pregnancy,
- •To be able to read and sign the informed consent.
- •Healthy subjects and a fasting blood glucose < 126 mg/dl
排除标准
- •Subjects that were less than 8 or more than 10 hours fasting,
- •To have symptoms and history of gastrointestinal, hepatic and cardiovascular diseases
- •Baobab intolerance or allergy,
- •Drug and/or supplement consumption capable of influencing plasma glucose
- •Have ingested baobab, water, coffee or alcohol intake and smoked tobacco consumption within 8 hours 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).
Postprandial blood glucose levels time curve
时间窗: Before intervention and after 30, 60, 90, and 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
Blood glucose maximum concentrations
时间窗: At 120 minutes after intervention
Mean blood glucose levels (mmol/L)
次要结局
- Weight of participants(At baseline)
- Body mass index of participants(At baseline)
- Height of participants(At baseline)
- Total protein intake of participants(At the day before intervention)
- Total carbohydrate intake of participants(At the day before intervention)
- Total energy intake intake of participants(At the day before intervention)
- Total lipid intake of participants(At the day before intervention)
- ABTS radical (ABTS+) inhibition capacity(At baseline)
- Total phenols content determination(At baseline)
- Proanthocyanidins content determination(At baseline)
- Nitric oxide inhibition capacity(At baseline)
- Hydrolysable tannins content determination(At baseline)
- DPPH radical scavenger capacity(At baseline)
- Ferric Reducing Antioxidant Power (FRAP) determination(At baseline)
- Superoxide radical inhibition capacity(At baseline)