High-Sugar Meal Effects on High Blood Sugar

Overseen By Bryant Keirns, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ball State University

Must not be taking: Anti-inflammatories, Glucose-lowering, Lipid-lowering

Disqualifiers: Cardiometabolic, Inflammatory, Tobacco, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a cinema-style meal, high in sugar and carbs, affects heart and metabolic health. It consists of two parts: one where participants consume the meal on an empty stomach, and another where they first have a high-fat breakfast. The trial seeks generally healthy individuals without heart or inflammatory conditions and who are not taking medications like anti-inflammatories or statins. Those who enjoy movie snacks and meet these criteria might be suitable candidates. As an unphased study, this trial provides a unique opportunity to contribute to understanding the impact of diet on health.

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking anti-inflammatory drugs if you use them more than twice a week, and you cannot use glucose-lowering or lipid-lowering drugs.

What prior data suggests that this cinema-style meal is safe?

Research has shown that typical movie theater snacks like soda, popcorn, and candy can make it difficult to maintain steady blood sugar levels. One study found that these snacks often contain high amounts of sugar and carbohydrates, leading to sudden increases in blood sugar.

Although specific data on the safety of these snacks in clinical trials is lacking, they are commonly consumed in everyday life without major health issues for most people. However, those concerned about blood sugar levels might find these snacks less suitable. Participants in a study about these snacks will likely receive close monitoring to detect any issues early. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how consuming a cinema-style meal impacts blood sugar levels in different situations. Unlike standard dietary advice for managing high blood sugar, which often focuses on low-sugar, balanced meals, this trial investigates the effects of a high-sugar, high-fat meal. By comparing responses between those who eat this meal after fasting and those who have already eaten a high-fat breakfast, researchers aim to uncover insights into the body's response to different meal timings and compositions. This could potentially lead to new recommendations for managing blood sugar spikes in everyday scenarios.

What evidence suggests that this trial's treatments could be effective?

Research shows that popcorn, a common movie theater snack, is high in fiber, which can help maintain steady blood sugar levels. It typically doesn't cause a spike in blood sugar unless sugary toppings are added. While popcorn is a whole grain and generally a safe snack, the effects of consuming it with other sugary and starchy foods on blood sugar remain unclear. This trial will compare the effects of a high-sugar, high-carb meal, like one from a movie theater, on blood sugar levels and overall health in two contexts: the Fasting Meal Trial, where participants consume the meal while fasted, and the Fed Meal Trial, where participants consume the meal after a high-fat breakfast. ^{1 3 6 7 8}

Who Is on the Research Team?

Bryant Keirns

Principal Investigator

Ball State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I do not have heart disease or type 2 diabetes.

Not pregnant or expecting to become pregnant (females only)

Does not have a pacemaker

Exclusion Criteria

I am a woman and have gone through menopause.

I am taking medication to lower my blood sugar.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fasting Meal Trial

Participants consume a movie theater style meal while fasting, with serial blood draws and FMD measurements over a four-hour period

1 day

1 visit (in-person)

Fed Meal Trial

Participants consume a high-fat breakfast, followed by a movie theater style meal after a three-hour break, with serial blood draws and FMD measurements over a four-hour period

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cinema-style Meal

Trial Overview

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).

How Is the Trial Designed?

Group I: Fed Meal Trial Experimental Treatment 1 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 Trial Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Ball State University

Lead Sponsor

Trials

10

Recruited

670+

Published Research Related to This Trial

In a study involving 25 teenage insulin-dependent diabetic patients, consuming a standard hamburger did not result in significantly different postprandial blood glucose levels compared to an isocaloric cheese sandwich.

The findings suggest that hamburgers of this specific composition can be safely included as a substitute for snack meals in the diets of diabetic patients without negatively affecting their metabolic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A hamburger may be included in the diabetic diet. A questionnaire study of glycemic response and dietary treatment in connection with a hamburger meal in teenage diabetics]. Clemmensen, NK., Nielsen, GL.[2016]

A study of vending machine offerings at a Bronx-based college revealed that snacks contained significantly higher calories (227 kcal) and sodium (208 mg) per serving compared to beverages (132 kcal, 90 mg), highlighting a potential dietary challenge for students.

Only 32% of snacks and 62% of snacks qualified as 'smart snacks' based on calorie and sodium limits, indicating a need for colleges to provide healthier, less-processed food options with lower added sugar content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional quality of snacks and beverages sold through vending machines in a large Hispanic-serving urban college campus in the United States: A cross-sectional study. Samuel, L., Odoom-Darko, E., Del Rosario, SJ., et al.[2023]

A study in Cardiff identified the ten most popular novelty sweets among high school students, which are easily accessible and priced between 39p and £1, making them affordable for children and young adults.

These sweets are often displayed at low heights in shops, with 73% of stores placing them within easy reach of all age groups, raising concerns about their contribution to dental issues and obesity among youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The availability of novelty sweets within high school localities. Aljawad, A., Morgan, MZ., Rees, JS., et al.[2022]

A study of 568 food items sold in public primary and secondary school canteens in Kelantan, Malaysia, revealed that a significant portion (29.1%) of these items were high in sugar, with only 0.9% classified as healthy choices.

Despite existing dietary guidelines, a large number of unhealthy food items, including confectionery and sugary drinks, were found in school canteens, indicating a need for interventions to promote healthier food options for students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Food Quality in School Canteens: A Comparative Quantitative Study between Primary and Secondary Schools in Malaysia. Foo, LH., Tan, YJ.[2021]

In a study involving 32 healthy lean males, consuming low energy density (LED) foods led to lower energy intake during lunch compared to high energy density (HED) foods, regardless of whether the preload was sweet or savory.

Participants who consumed HED preloads experienced a significantly higher spike in postprandial blood glucose levels compared to those who had LED preloads, indicating that focusing on low energy-dense foods could help manage overall energy intake and improve blood sugar control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Consuming Preloads with Different Energy Density and Taste Quality on Energy Intake and Postprandial Blood Glucose. Tey, SL., Salleh, N., Henry, CJ., et al.[2018]

In a study evaluating the blood sugar levels of patients with insulin-independent diabetes and obesity, as well as normal volunteers, it was found that certain foods have varying effects on blood glucose levels, with pure glucose and starchy foods like rice and bread causing the highest spikes.

Milk products, lentils, and certain grains like macaroni and millet showed a moderate effect on blood sugar levels, making them more suitable options for patients with diabetes compared to other high-glycemic foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of various food products on blood sugar level in patients with diabetes mellitus and obesity]. Kurbanov, SK., Khasaev, ASh., Gapparov, MM.[2006]

In a study involving nine healthy older adults, consuming a high dietary fiber snack (DF-BISCUIT) resulted in significantly lower postprandial glucose levels compared to a regular snack (BISCUIT).

The beneficial effects of the DF-BISCUIT not only reduced blood glucose levels after dinner but also suppressed glucose levels and areas under the curve (AUCs) after breakfast the following day, indicating a lasting impact on glucose control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Intake of a Snack Containing Dietary Fiber on Postprandial Glucose Levels. Kim, HK., Nanba, T., Ozaki, M., et al.[2020]

A study of 165 grain-based muesli bars in Sydney found that while 66% were whole grain and 56% were a source of dietary fiber, none were low in sugar, highlighting the need for better nutritional choices among these products.

Compared to 2015, there was a significant reduction in sugar content in muesli bars (from 26.6 g to 23.7 g per 100 g), and the number of whole grain bars increased by 31%, suggesting improvements in the nutritional quality of these snacks over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Nutrition Review of Grain-Based Muesli Bars in Australia: An Audit of Supermarket Products. Curtain, F., Grafenauer, S.[2020]

In a study involving 9 adult diabetics and 3 healthy subjects, breakfasts high in oligosaccharides resulted in smaller increases in blood glucose levels compared to those with more wheat starch, suggesting that oligosaccharides may have a beneficial effect on blood sugar control.

However, meals rich in oligosaccharides also led to symptoms of hypoglycemia and inadequate satiety, indicating that while they may help manage blood glucose, they could pose risks of overconsumption and should be approached with caution in diabetic diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Studies of glycemia and glucosuria in diabetics after breakfast meals of different composition. Lenner, RA.[2018]

In a study involving 36 normal weight children aged 11 to 13, consuming boiled and mashed potatoes (BMP) led to a significant reduction in calorie intake (30-40% less) and increased feelings of fullness compared to other carbohydrate dishes like rice and pasta.

The study found that the physiological effects of carbohydrate foods on blood glucose and insulin levels do not align with their glycemic index rankings, indicating that BMP may be more satiating despite being a high GI food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of potatoes and other carbohydrate side dishes consumed with meat on food intake, glycemia and satiety response in children. Akilen, R., Deljoomanesh, N., Hunschede, S., et al.[2018]

Menu labeling in Ontario, mandated by the Healthy Menu Choices Act, led to significantly lower energy content in menu items from regulated restaurants (320 kcal) compared to unregulated ones (470 kcal), indicating a positive impact on nutritional quality.

Regulated restaurants also offered menu items with lower levels of saturated fat, sodium, and total sugars, suggesting that menu labeling may help improve the overall healthiness of restaurant foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Ontario Menu Labelling Regulations on Nutritional Quality of Chain Restaurant Menu Items-Cross-Sectional Examination. Yang, Y., Ahmed, M., L'Abbé, MR.[2023]

In a study involving 14 adolescents with diabetes, consuming a prescribed diabetes snack resulted in a higher peak blood glucose level compared to eating a milk chocolate bar or potato chips, but the differences were not statistically significant.

The findings suggest that occasionally substituting a regular diabetes snack with an isocaloric amount of milk chocolate or potato chips does not negatively affect postprandial blood glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycaemic effect and satiating capacity of potato chips and milk chocolate bar as snacks in teenagers with diabetes. Cedermark, G., Selenius, M., Tullus, K.[2019]

A prebreakfast high-protein snack significantly reduces postbreakfast blood sugar levels in individuals with type 2 diabetes, showing a nearly 40% decrease in glucose rise compared to having breakfast alone.

The study involved 10 participants and demonstrated that the snack led to a lower incremental area under the glucose curve, indicating improved metabolic control after breakfast.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing the second-meal effect in type 2 diabetes: practical use of a soya-yogurt snack. Chen, MJ., Jovanovic, A., Taylor, R.[2022]

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This pilot study examined the frequency and healthfulness of food advertising in movie theatres in the United States and Canada.

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Your Blood Sugar-Safe Guide to the Movie Theater Snack ...

The typical movie theater snack environment presents several challenges for maintaining stable blood sugar levels. Most options are heavily ...