Health Professions Building, Ball State University
Muncie, Indiana, 47306, United States
Location status: Recruiting
NCT Number: NCT07650058
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Muncie, Indiana, 47306, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 262 grams of fresh mango.
High-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 36 grams of table sugar.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, up to 1 year.
The investigators will measure soluble CD14 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.
Time frame: Through study completion, up to 1 year.
The investigators will measure acceptability of each meal with a survey at each study visit once post-meal.
Time frame: Through study completion, up to 1 year.
The investigators will measure satiety through a survey at baseline and at 30-, 60-, 90-, 120-, 150-, and 180-minutes after the meal.
Time frame: Through study completion, up to 1 year.
The investigators will measure body composition using bioelectrical impedance (InBody).
Contact information is provided by the study sponsor or research team.
Ball State University
Other
Effects of Fresh Mango as a Table Sugar Replacement on Postprandial Intestinal Permeability and Inflammation Following a High-Sugar Breakfast.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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