Acute Inflammatory and Metabolic Effect of High Fructose Intake in Normal Weight Women: Double Blind, Randomized Crossover Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- Changes in serum levels of triglycerides
研究概览
简要总结
Fructose consumption is associated with the development of metabolic diseases and low-grade inflammation. However, the acute effect of a single meal rich in fructose on the metabolic and inflammatory response is not fully understood. This study will to evaluate the acute metabolic and inflammatory effect caused by a meal containing fructose overload. This will be a three-arm crossover, randomized, double-blind clinical trial.
Participants will undergo the three interventions for random order: (i) standardized meal plus sucrose overload; (ii) standardized meal plus glucose overload; (iii) standardized meal plus fructose overload. During the washout period (7 to 21 days), the subjects will instructed to maintain their usual eating behavior and physical activity.
On the day of each intervention, participants will to the outpatient clinic in the morning after an overnight fast. Anthropometric data (weight, height, and waist circumference) will collected. Body composition will evaluated using bioimpedance (Quantum® apparatus, RJM Systems, Michigan) and blood pressure and heart rate (digital monitor, model HEM705CP®, Omron) will measured after 30 minutes of rest.
A catheter with a three-way stopcock will inserted into the arm of the volunteers. Blood samples (5mL) will collected after overnight fasting (baseline) and 30, 60, 120, and 240 minutes after the standardized meal containing sucrose or glucose or fructose overload. Participants will remain seated throughout the evaluation period. Participants will receive a standardized meal of bread, ham, and margarine plus a sweetened drink (200mL) with similar amounts of different carbohydrates (sucrose, glucose, or fructose) in each intervention. The meals will provide 25% of the energy requirements, calculated from the resting energy expenditure measured by indirect calorimetry (KORR®, MetaCheck) multiplied by the activity factor plus 10% referring to the thermal effect of food. The meal will consiste of 15% of protein, 30% of fat, and 55% of carbohydrate (30% of complex carbohydrates and 25% of sucrose or glucose or fructose).
Serum levels of glucose, triglycerides, total cholesterol, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will be measured by colorimetric enzymatic test. Serum levels of adiponectin, leptin, resistin and TNF will be measured by Enzyme Linked ImmuneSorbent Assay (ELISA). Serum levels of IL-2, IL-4, IL-5, IL-6, IL-10, IL-17, IFN-γ and eotaxin will be obtained by the Cytometric Bead Array (CBA).
详细描述
This will be a three-arm crossover, randomized, double-blind clinical trial performed at the Alpha Institute of Gastroenterology of the Hospital das Clínicas (Belo Horizonte, MG, Brazil). All experimental procedures will be conducted according to the guidelines laid down in the Declaration of Helsinki. The research protocol was approved by the Institutional Review Board of the Universidade Federal de Minas Gerais (CAAE: 21852314.7.0000.5149). All volunteers will signed the informed consent prior to the start of the study.
Sample The sample size of 17 subjects was calculated considering the minimum number of participants to detect a difference of at least 11 mg/dL in the levels of triglycerides, 1.2 ng/mL in adiponectin and 1.9 pg/mL in TNF (pilot study) before and after the intake of a single meal containing a fructose overload, 95% confidence interval and statistical power of the 80%.
Study design Each participant will in three visits with washout period between 7 and 21 days. At each visit, the participant will pass by a different intervention. Three interventions will curr in random order: (i) standardized meal plus sucrose overload; (ii) standardized meal plus glucose overload; (iii) standardized meal plus fructose overload. During the washout period, the subjects will instructed to maintain their usual eating behavior and physical activity. Participants will instructed to avoid consuming caffeine and alcoholic beverages and perform intense physical activity within 24 hours before each visit.
On the day of each intervention, participants will go to the outpatient clinic in the morning after an overnight fast. Anthropometric data (weight, height, and waist circumference) will collected. Body composition will evaluated using bioimpedance (Quantum® apparatus, RJM Systems, Michigan) and blood pressure and heart rate (digital monitor, model HEM705CP®, Omron) will measured after 30 minutes of rest.
A catheter with a three-way stopcock will inserted into the arm of the volunteers. Blood samples (5mL) will collected after overnight fasting (baseline) and 30, 60, 120, and 240 minutes after the standardized meal containing sucrose or glucose or fructose overload. Participants remained seated throughout the evaluation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged
- •20 and 47 years
- •body mass index (BMI) from 18.50 to 24.99 kg/m²
排除标准
- •chronic diseases, such as DM, chronic renal failure (CRF), cardiovascular or hepatic diseases, acute inflammatory or autoimmune diseases;
- •participants with glycemia > 99 mg/dL;
- •triglycerides > 200 mg/dL;
- •prior bariatric surgery for weight loss;
- •people who were taking medication for thyroid disorders, dyslipidemia, insulin sensitivity or DM, CRF, cardiovascular and hepatic diseases, inflammation and/or infection, immunosuppressive and weight loss;
- •smokers or people who drink more than two doses of alcohol a day (28g of pure alcohol); and (vii) pregnancy or breast-feeding.
结局指标
主要结局
Changes in serum levels of triglycerides
时间窗: Change from Baseline serum level at 240 minutes postprandial.
Triglycerides (ml/dL)
Changes in serum levels of adiponectin
时间窗: Change from Baseline serum level at 240 minutes postprandial.
Adiponectin (pg/dL)
Changes in serum levels of tumor necrosis factor
时间窗: Change from Baseline serum level at 240 minutes postprandial.
Tumor necrosis factor (pg/dL)
次要结局
- Changes in serum levels of glucose(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of interleukin-5(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of interleukin-4(Change from Baseline serum level at 240 minutes postprandial.)
- Change in metabolic profile(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of ofeotaxin(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of interleukin-6(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of interleukin-10(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of interferon gamma(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of cholesterol(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of Aspartate aminotransferase(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of interleukin-2(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of interleukin-17(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of Alanine aminotransferase(Change from Baseline serum level at 240 minutes postprandial.)
- Changes in serum levels of Leptin(Change from Baseline serum level at 240 minutes postprandial.)
研究者
Adaliene Versiani M. Ferreira
Clinical Professor
Federal University of Minas Gerais