Beneficial Effects of Quinoa (Chenopodium Quinoa Willd) in the Prevention of Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Blood glucose fluctuations
研究概览
简要总结
Quinoa is a pseudo-cereal and has potential health benefits and exceptional nutritional value. It is a food rich in proteins of high biological value, in unsaturated fats and fiber, it is also a grain low in carbohydrates and with a low glycemic index. Concretely, quinoa could produce a benefit on postprandial glycemia that would result in lower type 2 diabetes (T2D) incidence.
A cross-over design pilot clinical study with a nutritional intervention for 8 weeks were performed: 4 weeks on a regular diet (RD) and 4 weeks on a quinoa diet (QD). Nine subjects aged ≥65 years with prediabetes were monitored during the first 4 weeks of RD with daily dietary records and FreeStyle Libre®. Subsequently, participants started the DQ where quinoa and 100% quinoa-based products replaced foods rich in complex carbohydrates that they regularly consumed by the first 4 weeks of DR.
The glycemic measurements recorded by the sensors were considered as functions of time and the effects of nutrients consumed at the intended time period were analyzed by means of function on scalar regression (fosr) model.
详细描述
The study was a cross-over pilot clinical study consisting of two periods. The first period was only an observational and monitoring phase where participants just continued with their regular diet (RD), for this reason all participants initiated this period and wash-out term was no needed. Subsequently, with the data of the first phase obtained, the subjects began the second period in which they had to undergo a nutritional intervention with a quinoa diet (QD).
A total of six visits plus two quinoa products collection days were programmed. After the pre-study visit (V0) which took place a week before start nutritional intervention and where researchers obtained signed informed consent, participants were summoned for a first visit (V1) where they were explained how they should fill in the dietary records and they were applied with the FreeStyle Libre®.
Subjects then began RD, a period of 4 weeks during which only their normal life was monitored. After the first 14 days of this, a second visit (V2) was made where the dietary record was collected that would serve to account for their usual consumption of cereals, flours, tubers and legumes, the FreeStyle Libre® sensor was also collected.
The last day on RD period, on day 28, they were cited (V3) in consultation where blood samples after an 8 hours fast, anthropometrics measurements and blood pressure measure where obtained and for the placement of the new FreeStyle Libre® sensor. Participants were asked about their physical activity and exercise practice during those past 4 weeks by a short questionnaire adapted from the Minnesota Leisure Time Physical Activity Questionnaire for individuals of advanced age (VREM questionnaire) and a new empty 14-day dietary record was given. In addition, the volunteers received the first foods with quinoa to initiate QD the next day. Products were delivered weekly, for conservation reasons but also to ensure that they followed an adequate consumption, they had to go through consultation to pick up the product and gave the researchers the empty packs where quinoa products had been.
On the next visit the day 42 (V4) the Freestyle Libre® sensor was collected and the filled dietary record was collected. Finally, after 28 days of quinoa diet they were summoned for the last visit the day 56 (V5) where all the determinations were repeated identically as V3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Glucose levels between 100 and 125 mg/dL and without a previous diagnosis of diabetes
排除标准
- •Do not consume a diet with daily presence of grains or cereals derivatives, tubers or/and legumes, or they presented any other health problem that the research staff considered contraindicated:
- •Treatment with oral antidiabetic drugs Chronic treatment with oral steroids and / or AINES Treatment with oral antidiabetic agents and / or insulin Treatment with immunosuppressive drugs Diagnosis of active neoplasm Diagnosis of HIV or AIDS Abnormal liver profile (> 6 times normal values) Diagnosis of Acute Psychiatric Sdr Presence of serious acute concomitant disease, which it requires more than 7 days of recovery.
- •Major cardiovascular event (stroke, myocardial infarction) in the month prior to randomization.
- •Any other condition that the investigator considers to be inoperative so that the subject conducts the study.
结局指标
主要结局
Blood glucose fluctuations
时间窗: Comparing data obtained during 2 hours per day along 14 days both during regular diet and quinoa diet
Glucose fluctuations were measured by FreeStyle Libre® Flash Glucose Monitoring System (Abbott Laboratories) which measures interstitial fluid glucose concentrations. The sensor was applied by researchers on to the back of the upper arm of subjects using the applicator and participants were trained to obtain electronically all the glucose records concentrations every 15 minutes so they had to scan at least once every eight hours. The glucose level monitoring sensor takes measurements at discrete time points for each patient Therefore, firstly the glucose curves have been linearly interpolated and has been considered as a function of time in minutes over interval. Then, a functional model analyses were constructed as described in "study protocol and statistical analyses" document attached.
次要结局
- Blood pressure(Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet)
- Height in meters(Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet)
- Weight in kilograms(Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet)
- Body mass index (BMI)(Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet)
- Glucose homeostasis (mg/dl)(Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet)
- Glycated hemoglobin HbA1c (%)(Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet)
- Circumferences in cm(Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet)
- Insulin levels (mU/L)(Data obtained after 28 days quinoa diet compared to data obtained after 28 days regular diet)
- Nutrient intake recorded(Data obtained during 28 days quinoa diet compared to data obtained during 28 days regular diet)
研究者
Diana Alicia Diaz Rizzolo
PhD, RD, Clinical Professor.
Institut d'Investigacions Biomèdiques August Pi i Sunyer