Effect of Flaxseed Supplementation on Glycemic Control in Prediabetic Adults
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- 2h-plasma glucose
研究概览
简要总结
Prediabetes is the term used to describe the condition where blood glucose level is higher than normal but lower than the diagnosis criteria of type 2 diabetes mellitus (T2DM). This condition confers a high risk for the development of T2DM and other diseases. Prediabetes could be reversible with lifestyle modifications, which include medical-nutrition therapy. Within these modifications, a healthy diet high in fiber and sources of alpha-linolenic acid is recommended. Flaxseed is a seed that is considered a functional food because it can provide health benefits due to its high content of fiber, alpha-linolenic acid, and lignans, these components could improve glycemic control in prediabetes patients by different mechanisms. The purpose of this study is to assess the effect of flaxseed on glycemic control in prediabetic adults.
详细描述
Prediabetes is a condition that increases the risk of T2DM and other diseases, its prevalence increases year after year despite being a reversible condition through lifestyle changes, diet, and medication. Therefore, it is important to find new strategies that, together with the known treatments, help to improve glycemic control in people with prediabetes and thus their risk of developing TDM2. Among these strategies may be the consumption of flaxseed, one of the main sources of alpha-linolenic acid (ALA), an omega-3 fatty acid, lignans, and fiber.
This open-label randomized clinical trial will include, prior informed consent, 96 men and women with prediabetes, subjects will be allocated in two groups, the intervention group or the control group. The intervention group will receive 30 g per day of ground flaxseed dissolved in water, (15 g in the morning and 15 g in the night), they will also be provided with a dietary plan. The Control group will not receive any supplementation, only a dietary plan controlled in alpha-linolenic acid.
The intervention will last 12 weeks; during this time, all patients will be scheduled every 2 weeks for follow-up visits. During the follow-up visits, subjects will be evaluated for changes in gastrointestinal symptoms, and adherence to supplementation, which will be assessed by a daily record, and the return of empty or unopened bags of flaxseed.
Every month, all subjects will undergo anthropometric, clinical, dietary, and biochemical evaluations that include measurements of body weight, body composition, waist, and hip circumferences, blood pressure, physical activity, quality of food intake, dietary intake, fasting plasma glucose, hemoglobin A1C, insulin, LDL-C, HDL-C, triglycerides, and total cholesterol; an oral glucose tolerance test will be performed at baseline and the end of the study to each subject.
At the end of the study, the obtained information will be shared with the scientific community to provide a possible food-based strategy for prediabetic adults in addition to the already known prediabetes treatment. All participants of the study will be beneficiated with free nutritional, anthropometric, and biochemical assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who agree to participate in the study once they have read and signed the informed consent
- •Men and women
- •Fasting glucose levels between 100 and 125 mg/dl
- •Age 30-59 years
- •Stable weight in the last 3 months (no more than 5% weight change)
排除标准
- •Fasting glucose <100 and >125 mg/dl
- •Consumption of drugs that may modify glucose levels
- •Consumption of flaxseed, chia, or omega-3, three months before the study
- •Alternative diets (vegetarian, vegan, ketogenic, etc.)
- •Pregnancy and breastfeeding
- •Allergy or intolerance to flaxseed
结局指标
主要结局
2h-plasma glucose
时间窗: 12 weeks
Changes in 2h-plasma glucose concentration after an oral glucose tolerance test after the intervention (mg/dL)
Fasting plasma glucose
时间窗: 12 weeks
Changes in plasma glucose concentration after the intervention (mg/dL)
Hemoglobin A1C
时间窗: 12 weeks
Changes in hemoglobin A1C after the intervention (%)
次要结局
- Physical activity level(12 weeks)
- Food intake quality(12 weeks)
- Insulin(12 weeks)
- Lipid profile(12 weeks)
- Body Weight(12 weeks)
- Insulin resistance(12 weeks)
- Blood pressure(12 weeks)
- Dietary ingestion(12 weeks)
- Body composition(12 weeks)
- Waist and hip circumferences(12 weeks)
- Stool classification(12 weeks)
研究者
Gabriela Macedo Ojeda
Professor researcher A
Centro Universitario de Ciencias de la Salud, Mexico