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Postprandial Effects of Fresh Mango as a Table Sugar Replacement in High-Sugar Breakfasts.

10. juni 2026 opdateret af: Ball State University

Effects of Fresh Mango as a Table Sugar Replacement on Postprandial Intestinal Permeability and Inflammation Following a High-Sugar Breakfast.

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

35

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Indiana
      • Muncie, Indiana, Forenede Stater, 47306
        • Rekruttering
        • Health Professions Building, Ball State University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Kornforbrug med bordsukker
Under korn- og bordsukkerarmen forbruger deltagerne en skål med cornflager med 2% mælk sødet med bordsukker.
Andet: High-Glycemic Breakfast Containing Cereal and Table Sugar
High-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 36 grams of table sugar.
Eksperimentel: 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.
Andet: High-Glycemic Breakfast Containing Cereal and Fresh Mango
High-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 262 grams of fresh mango.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
LPS
Tidsramme: 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.
Through study completion, up to 1 year.
LPS Binding Protein
Tidsramme: 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.
Through study completion, up to 1 year.
IL-6
Tidsramme: 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.
Through study completion, up to 1 year.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptabilitet
Tidsramme: Gennem undersøgelsesafslutning, op til 1 år.
Efterforskerne måler acceptabilitet af hvert måltid med en undersøgelse ved hvert undersøgelsesbesøg en gang efter måltidet.
Gennem undersøgelsesafslutning, op til 1 år.
sCD14
Tidsramme: 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.
Through study completion, up to 1 year.
Satiety
Tidsramme: 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.
Through study completion, up to 1 year.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Kropssammensætning
Tidsramme: Gennem undersøgelsesafslutning, op til 1 år.
Efterforskerne måler kropssammensætning ved hjælp af bioelektrisk impedans (INBODY).
Gennem undersøgelsesafslutning, op til 1 år.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ball State University

Samarbejdspartnere

National Mango Board

Efterforskere

  • Ledende efterforsker: Bryant Keirns, PhD, Ball State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2026

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. januar 2027

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-FY2025-25-1

Plan for individuelle deltagerdata (IPD)

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