Effects of Fresh Mango as a Table Sugar Replacement on Postprandial Intestinal Permeability and Inflammation Following a High-Sugar Breakfast.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- LPS
研究概览
简要总结
Systemic inflammation and intestinal hyperpermeability (disruption of the gut barrier which allows nutrient molecules and bacteria to enter the bloodstream) are triggered by consumption of high-sugar meals and are linked to future development of cardiovascular disease (CVD). Previous research indicates that fresh mangos have properties that have positive effects on the intestinal barrier and local gut inflammation. The investigators want to understand if replacing table sugar (sucrose) with sugar from fresh mango (which also contains fiber and plant bioactives) will lead to decreased inflammatory and permeability biomarkers after eating a high-sugar breakfast. The investigators will compare the postprandial (post meal) levels of inflammatory (IL-6) and permeability (LPS, lipid binding protein (LBP), and soluble CD14) biomarkers in blood from participants who have consumed a meal sweetened with either sucrose or fresh mango.
详细描述
The investigators will use banked serum samples from an ongoing randomized crossover study to determine the effects of fresh mango as a substitute for added sugar on postprandial glucose and insulin in the context of high glycemic and low glycemic breakfasts. The investigators will use samples banked from the high glycemic meals and compare indicators of intestinal permeability and inflammation following corn flakes + fresh mango and corn flakes + sucrose. the samples come from recruited individuals with a BMI in the 18.5-35.0 kg/m2 range from the Ball State University campus and surrounding communities. Each participant (N=35) will complete two meal trials in random order. An indwelling intravenous catheter (IV) is placed in a forearm vein and a baseline blood sample is collected. Next, participants will consume one of the two test meals: (1) corn flakes with 2% milk + fresh mango and (2) corn flakes with 2% milk + sucrose. Corn flakes based meals reflect a commonly consumed breakfast food with high glycemic index. In each meal, total sugar (grams) will be identical, meals are nearly isocaloric (+/- ≤ 4 kcal) and macronutrients are matched.
After each meal, additional whole blood samples will be collected at 30-, 60-, 120-, and 180 minutes after participants take their first bite of food. Blood is collected into serum separator tubes, allowed to clot, centrifuged, and stored at -80 degrees C until study completion. Serum LPS, LBP, and sCD14 will be assayed in duplicate at all timepoints as indicators of intestinal permeability. Direct LPS measurement will be carried out using a cutting-edge assay (Pyrogene rFC; Lonza) that detects LPS in a single enzymatic step. LPS assays will be conducted with LPS-free consumables in sterile biosafety cabinet. LBP and sCD14 will be measured with commercially available ELISAs. Serum IL-6 will be assayed in duplicate at all time points as a measure of inflammation. IL-6 analyses will be measured externally at the Indiana University School of Medicine Translational Core on a high-sensitivity single-plex assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 45 years.
- •Body mass index between 18.5-35.0 kg/m2
- •Not pregnant or expecting to become pregnant (females only)
- •Not postmenopausal (females only).
- •No known chronic medical conditions (e.g., type 2 diabetes, cardiovascular disease, inflammatory diseases, etc.)
- •No history of using tobacco/illicit drugs
- •No history of using glucose-lowering medications/supplements.
- •No history of using prescribed anti-inflammatory medications
- •Does not use over-the-counter anti-inflammatory medications ≥2x/week
- •Does not have a pacemaker.
- •No relevant food allergies/intolerances
- •Able to lay supine for at least ten minutes.
排除标准
- •Not between the ages of 18-45
- •Body mass index < 18.5 kg/m2 or >35.0 kg/m2
- •Pregnant (females only)
- •Postmenopausal status (females only).
- •Been diagnosed with a chronic medical conditions (e.g., type 2 diabetes, cardiovascular disease, inflammatory diseases, etc.)
- •Uses tobacco products or any illicit drugs.
- •Uses glucose-lowering drugs/supplements.
- •Regularly takes anti-inflammatory drugs (more than 2x week).
- •Have a pacemaker.
- •Allergic to mango, wheat, gluten, and/or milk.
- •Unable to lay in supine position in the dark for at least ten minutes.
研究组 & 干预措施
Cereal Consumption with Fresh Mango
During the Cereal and Fresh Mango arm, participants will consume a bowl of corn flakes with 2% milk sweetened with fresh mango.
干预措施: High-Glycemic Breakfast Containing Cereal and Fresh Mango (Other)
Cereal Consumption with Table Sugar
During the Cereal and Table Sugar arm, participants will consume a bowl of corn flakes with 2% milk sweetened with table sugar.
干预措施: High-Glycemic Breakfast Containing Cereal and Table Sugar (Other)
结局指标
主要结局
LPS
时间窗: Through study completion, up to 1 year.
The investigators will measure LPS at baseline and 30-, 60-, 120-, and 180- minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
LPS Binding Protein
时间窗: Through study completion, up to 1 year.
The investigators will measure LPS binding protein at baseline and 30-, 60-, 120-, and 180-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
IL-6
时间窗: Through study completion, up to 1 year.
The investigators will measure IL-6 at baseline and 30-, 60-, 120-, and 180-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
次要结局
- sCD14(Through study completion, up to 1 year.)
- Acceptability(Through study completion, up to 1 year.)
- Satiety(Through study completion, up to 1 year.)