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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBall State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

  • High-Glycemic Breakfast Containing Cereal and Fresh Mango

    Other intervention

    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 Containing Cereal and Table Sugar

    Other intervention

    High-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 36 grams of table sugar.

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Cereal Consumption with Fresh MangoExperimental treatment 1 intervention
Group B: Cereal Consumption with Table SugarExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

LPS

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.
2

LPS Binding Protein

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.
3

IL-6

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.

Secondary outcomes

1

sCD14

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.
2

Acceptability

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.
3

Satiety

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.

Other outcomes

1

Body Composition

The investigators will measure body composition using bioelectrical impedance (InBody).

Time frame
Through study completion, up to 1 year.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ball State University

Lead sponsor

National Mango Board

Collaborator