Comparison of the Glycemic Index of a Drink Made of Natural Concentrated Mango Puree With Natural Concentrated Pear Juice With That of Other Five Products Based on Mango and Pear in Different Solid Products and Drinks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Glycemic index of mango puree with natural pear juice beverage
研究概览
简要总结
The purpose of this study is to compare the glycemic index of a beverage made of natural concentrated mango puree with natural concentrated pear juice with other five different products based on natural mango and pear ingredients in the form of fruit or juice against a control of 50-gram glucose load.
详细描述
The participants will be recruited with an open invitation to participate, those who voluntarily accept, sign an informed consent, and meet the all inclusion criteria and none of the exclusion criteria will participate.
Each participant will receive a different product (of the seven products available) each day of the test (8 days in total), making sure everyone receives each one of the products. All products will be distributed in a randomized fashion for each of the participants. The 50-gram glucose load (gold standard) will be the reference or control, and will be taken twice by each subject in the test.
Each one of the products given will contain 50 grams of carbohydrate. The time given to consume the products will be 10 minutes total.
There will be a "wash out" period of three days in between each product.
The participants will eat the product and capillary glucose will be taken with a glucometer (Accu-Chek Performa System © 2009 Roche Diagnostics. Roche Products, México) at times: 0, 15, 30, 45, 60, 75, 90, 150 and 120 minutes. The glucometer will be calibrated with a standard glucose solution every day previous to the test. The results will be used to calculate the glycemic index. At the end of the 120 minutes, the participants will receive a questionnaire of digestive symptoms presented during the test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Ages 18 to 50 years
- •Body mass index between 18.5 and 27.4 kilograms divided by squared meters
- •Waist circumference ≤ 102 centimeters for men and ≤88 centimeters for women
- •Fasting capillary glucose ≤100 milligrams per deciliter
- •The night before the study:
- •10 hours fasting
- •Light dinner of their choice and repeat it every time before the study
- •No alcohol, coffee or tea drinks the previous night
- •No vigorous exercise the day before the test nor the morning of the test
排除标准
- •Consumption of any of the following: oral hypoglycemic drugs, oral or parenteral glucocorticoid drugs, thyroid hormones, stimulant of intestinal motility or other drugs that may interfere with the intestinal absorption during the test
- •Acute or chronic gastrointestinal infections
- •Breast feeding or pregnant women
- •Intestinal surgeries in the last 6 months
- •Allergies to any of the products we will be using
- •Subjects with gastrointestinal or metabolic diseases
- •Subjects with first grade family history of diabetes mellitus
- •Subjects with glucose intolerance, insulin resistance or diabetes mellitus
- •Subjects who dislike any of the products we will be using
- •Subjects with an acute (previous 24 hours) digestive crisis including: gastritis, diarrhea, and vomit, among others
- •Subjects with a history of mal-absorption
- •Suspension:
- •Subjects that do not arrive at the test-day
- •Fasting glucose ≥ 100 milligrams per deciliter the day of the test
- •Subjects who develop gastrointestinal disease during the study time frame
研究组 & 干预措施
Mango puree and pear juice beverage
Participants will drink 450 milliliters of the juice at time 0.
干预措施: Mango puree and pear juice beverage (Other)
Commercial mango juice
Participants will drink 450 milliliters of the juice at time 0.
干预措施: Commercial mango juice (Other)
Fresh natural mango
Participants will eat 400 to 500 grams of frozen mango pulp, along with 250 milliliters of water at time 0.
干预措施: Fresh natural mango (Other)
Frozen natural mango
Participants will eat 400 to 500 grams of frozen mango pulp, along with 250 milliliters of water at time 0.
干预措施: Frozen natural mango (Other)
Processed natural mango pulp
Participants will eat 400 to 500 grams of frozen mango pulp, along with 250 milliliters of water at time 0.
干预措施: Processed natural mango pulp (Other)
Mix of natural mango and pear
Participants will eat 400 to 500 grams of a mixture of fresh natural fruit containing mango (73%) and pear (27%), along with 250 milliliters of water at time 0.
干预措施: Mix of natural mango and pear (Other)
50 grams glucose load
Participants will drink 250 milliliters of the standard glucose load at time 0.
干预措施: 50 grams glucose load (Other)
结局指标
主要结局
Glycemic index of mango puree with natural pear juice beverage
时间窗: 8 days
Glycemic index will be calculated for 450 milliliters of this juice. The results will be expressed as mean ± standard deviation for each with a significance level of 0.05 for all the statistical tests.
次要结局
- Glycemic index of a commercial mango juice(8 days)
- Glycemic index of natural fresh mango(8 days)
- Glycemic index of natural frozen mango pulp(8 days)
- Glycemic index of processed natural mango pulp(8 days)
- glycemic index of a mixture of fresh mango 73 percent and fresh pear 27 percent(8 days)
- glycemic index of a 50 gram glucose load(8 days)
研究者
Leticia Elizondo-Montemayor
M.D.
Instituto Tecnologico y de Estudios Superiores de Monterey