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Nutritional Intervention

High-Sugar Meal Effects on High Blood Sugar

N/A

Recruiting

Led By Bryant Keirns

Research Sponsored by Ball State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-45 years old

Not postmenopausal (females only)

Must not have

Regularly take anti-inflammatory drugs (more than 2x week) or unable to temporarily suspend use of anti-inflammatory drugs

Been diagnosed with a cardiometabolic condition (e.g., heart disease, type 2 diabetes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how eating a meal high in sugar, carbs, and moderate in fat, like soda, popcorn, and candy typically eaten during a movie, affects heart and metabolism.

Who is the study for?

This trial is for healthy adults aged 18-45 who haven't been diagnosed with heart disease or diabetes, aren't pregnant, don't smoke or use drugs, and aren't taking medications like metformin or statins. It's not for those with chronic inflammation conditions or a pacemaker.

What is being tested?

The study examines the body's response to a cinema-style meal high in sugar and carbs. Participants will eat this meal under two different conditions: after fasting (no food) and when fed (not fasting).

What are the potential side effects?

Since this trial involves consuming common foods rather than medication, side effects may include short-term changes in blood sugar levels, feelings of fullness, thirst from high salt intake, and potential digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

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I am a woman and have not gone through menopause.

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I do not have heart disease or type 2 diabetes.

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I do not have a chronic inflammatory condition.

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I do not take medication to lower my blood sugar.

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I do not take medication to lower my cholesterol.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly take anti-inflammatory drugs more than twice a week.

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I have been diagnosed with a heart or metabolic condition like diabetes.

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I am not between the ages of 18 and 45.

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I am a woman and have gone through menopause.

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I am taking medication to lower my blood sugar.

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I am taking medication to lower my cholesterol.

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I have a long-term inflammatory condition like rheumatoid arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Flow-mediated dilation

Glucose

HDL-C

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Fed Meal TrialExperimental Treatment1 Intervention

During the fed meal trial, participants will report fasted and first consume a high-fat breakfast. Participants will then be asked to consume a movie theater style meal three hours later.

Group II: Fasting Meal TrialExperimental Treatment1 Intervention

During the fasting meal trial, participants will report fasted and consume a movie theater style meal.

0 / 13Eligibility criteria met