Snack Ingredients for Blood Sugar Control

Overseen By Denise Rodriguez, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: USDA, Western Human Nutrition Research Center

Must not be taking: Glucose affecting drugs

Disqualifiers: Diabetes, Cardiovascular, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how different snack ingredients affect blood sugar levels. Participants will consume snacks containing either honey or sugar, both alone and with almonds, to explore how these combinations impact glucose levels after eating. The researchers believe honey and almonds might help manage blood sugar while maintaining satiety. Women who are pre-menopausal and willing to eat these snacks, without major chronic illnesses like diabetes or heart disease, are ideal candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to nutritional science and potentially improve dietary recommendations.

Will I have to stop taking my current medications?

The trial excludes individuals who are routinely taking medications known to affect glucose response, so you may need to stop such medications to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that honey is usually easy to digest and might cause smaller blood sugar spikes than regular sugar. Some studies suggest that honey can lead to smaller increases in blood sugar for people with type 2 diabetes, but results vary, and not all studies agree.

When combined with almonds, honey might help control blood sugar better. Studies have found that almonds can lower fasting blood sugar levels and improve overall blood sugar management.

The FDA considers table sugar, or sucrose, safe, and it is commonly used in foods. However, consuming large amounts of sucrose, especially in drinks, can increase the risk of developing type 2 diabetes.

Adding almonds to a diet that includes sucrose might also help with blood sugar control. Research suggests that almonds can improve blood sugar levels when part of a balanced diet.

Overall, both honey and sucrose are generally safe to eat. Including almonds might help with blood sugar management. Participants should consider this information when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for blood sugar control because they explore natural snack ingredients like honey and almonds, which are not standard in current diabetes management. Unlike traditional medications that often involve synthetic drugs, these treatments use honey and sucrose, with and without almonds, to potentially regulate blood sugar levels. This approach could offer a more natural and dietary-based method for managing blood sugar, possibly with fewer side effects. Additionally, the use of continuous glucose monitoring allows for real-time tracking of blood sugar changes, providing valuable insights into how these ingredients impact glucose levels throughout the day.

What evidence suggests that this trial's treatments could be effective for blood sugar control?

Research shows that honey might help lower blood sugar levels. In studies with diabetic rats, honey significantly reduced blood sugar. In humans, results are mixed; some studies found a decrease in blood sugar, while others did not observe much change. This trial will evaluate the effects of honey and honey with almonds on blood sugar control. Research suggests that almonds may help control blood sugar, especially in people with prediabetes. Eating almonds with honey or sugar might manage blood sugar better than sugar alone, as almonds can reduce blood sugar spikes after meals. This trial will also assess the effects of sucrose and sucrose with almonds. However, more research is needed to understand the exact benefits of these combinations. ^{1 6 7 8 9}

Who Is on the Research Team?

Mary Kable, PhD

Principal Investigator

USDA, ARS, Western Human Nutrition Research Center

Nancy Keim, PhD

Principal Investigator

USDA, ARS, Western Human Nutrition Research Center

Kevin Laugero, PhD

Principal Investigator

USDA, ARS, Western Human Nutrition Research Center

Are You a Good Fit for This Trial?

This trial is for pre-menopausal women without chronic diseases like heart or kidney disease, diabetes, thyroid issues needing medication, bowel diseases, or recent major surgeries. They must be willing to eat snacks with honey, sugar, and nuts but can't have nut allergies or a BMI <18.5 or >40.

Inclusion Criteria

I am a woman and have not gone through menopause.

You are open to consuming snacks with honey, table sugar, and tree nuts.

Exclusion Criteria

You are allergic to tree nuts.

Women who have been pregnant or nursing within the last 6 months or plan to become pregnant during the trial will be ineligible

I have gone through menopause.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume honey and nuts or sugar and nuts, with continuous glucose monitoring

8 weeks

Daily visits for snack consumption

Wash-out

A wash-out period between treatment phases

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Honey
• Honey plus almonds
• Sucrose
• Sucrose plus almonds

Trial Overview

The study compares the effects of two snacks on blood sugar levels: one snack combines honey with nuts and the other combines table sugar with nuts. The goal is to see if honey and nuts together better manage glucose after eating compared to just sugar and nuts.

How Is the Trial Designed?

Group I: Sucrose alone and sucrose with almonds, then honey alone and honey with almonds Experimental Treatment 4 Interventions

Participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor. After a 14 day wash-out, participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor.

Group II: Honey alone and honey with almonds, then sucrose alone and sucrose with almonds Experimental Treatment 4 Interventions

Participants will be provided honey alone once each day for 3 days, then honey plus almonds for an additional 3 days while wearing a continuous glucose monitor. After a 14 day wash-out, participants will be provided sucrose alone once each day for 3 days, then sucrose plus almonds for an additional 3 days while wearing a continuous glucose monitor.

Who Is Running the Clinical Trial?

USDA, Western Human Nutrition Research Center

Lead Sponsor

Trials

64

Recruited

19,100+

National Honey Board

Collaborator

Trials

4

Recruited

320+

Published Research Related to This Trial

In a double-blind study with 60 participants consuming yogurt mixed with honey for 21 days, green walnut honey significantly reduced morning blood sugar levels by an average of 22.45%, indicating its potential as a natural treatment for diabetes.

While acacia honey also showed a slight decrease in blood sugar levels, other honey types (sea buckthorn and chlorella alga) did not result in significant changes, highlighting the unique efficacy of green walnut honey in blood sugar control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Yogurt Fortified with Honey Produced by Feeding Bees Natural Plant Extracts for Controlling Human Blood Sugar Level. Prokisch, J., El-Ramady, H., Daróczi, L., et al.[2022]

Low energy, fiber-enriched diabetic jams, cakes, and biscuits can be successfully made using sucrose substitutes and wheat bran, which help lower blood glucose levels in diabetic patients.

The study found that these specially formulated foods not only maintain good nutritional quality and shelf life but also significantly reduce plasma glucose levels in both lean and obese diabetes mellitus patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application potential for some sugar substitutes in some low energy and diabetic foods. Bakr, AA.[2019]

In a study involving 20 children with type 1 diabetes and 10 healthy controls, honey was found to have a lower glycemic index (GI) and peak incremental index (PII) compared to sucrose, suggesting it may be a safer sugar substitute for managing blood sugar levels in diabetic patients.

While honey did not significantly increase C-peptide levels in diabetic patients compared to glucose or sucrose, it did lead to a significant increase in C-peptide levels in healthy controls, indicating a different metabolic response that could be beneficial for non-diabetic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The glycemic and peak incremental indices of honey, sucrose and glucose in patients with type 1 diabetes mellitus: effects on C-peptide level-a pilot study. Abdulrhman, M., El-Hefnawy, M., Hussein, R., et al.[2022]

In a study involving 37 healthy participants over two 4-week trials, honey consumption led to significantly lower energy, carbohydrate, and sugar intake compared to sucrose, suggesting it may be a healthier alternative.

While both honey and sucrose initially raised serum triglyceride levels, only sucrose maintained this elevation after 4 weeks, indicating that honey may have a more favorable impact on lipid profiles over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Honey does not adversely impact blood lipids of adult men and women: a randomized cross-over trial. Al-Tamimi, AM., Petrisko, M., Hong, MY., et al.[2021]

In a study involving 33 chiropractic students, honey was found to cause fewer increases in blood sugar levels compared to sucrose, indicating it may be a better option for managing glucose intolerance.

Honey also resulted in fewer subjective symptoms of discomfort than sucrose, suggesting it is not only gentler on blood sugar but also more tolerable for consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential effects of honey, sucrose, and fructose on blood sugar levels. Shambaugh, P., Worthington, V., Herbert, JH.[2006]

In a 5-day double-blind study with 16 participants who have insulin-dependent diabetes, consuming snacks with up to 7% added sucrose did not negatively impact blood glucose control compared to snacks sweetened with aspartame.

Both groups showed no significant differences in blood glucose levels or serum fructosamine concentrations before and after the study, indicating that moderate sucrose intake can be safely included in the diet without compromising short-term metabolic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of sucrose-containing snacks on blood glucose control. Wise, JE., Keim, KS., Huisinga, JL., et al.[2019]

In a study of 48 type 2 diabetic patients over 8 weeks, those who consumed natural honey showed significant reductions in body weight, total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, along with an increase in high-density lipoprotein (HDL) cholesterol.

Despite these positive effects on body weight and blood lipids, the honey group also experienced a significant increase in hemoglobin A1C levels, suggesting that diabetic patients should consume honey cautiously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of natural honey consumption in diabetic patients: an 8-week randomized clinical trial. Bahrami, M., Ataie-Jafari, A., Hosseini, S., et al.[2022]

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 STZ-induced diabetic mice over five weeks, honey and its combination with metformin effectively prevented hyperglycemia and improved insulin secretion, liver health, and kidney function.

Honey treatment significantly enhanced glucokinase activity while suppressing enzymes that contribute to glucose production, suggesting a beneficial mechanism for managing glucose metabolism in diabetic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of honey with metformin enhances glucose metabolism and ameliorates hepatic and nephritic dysfunction in STZ-induced diabetic mice. Ding, Y., Xu, M., Lu, Q., et al.[2020]

Rats exposed to honey solution (HS) consumed significantly more than those given sucrose solution (SS) or glucose/fructose solution (GFS), but this higher consumption did not lead to notable differences in biochemical or anthropometric measures after 14 weeks.

The sucrose solution group showed the highest liver damage, indicating potential risks associated with high sucrose intake, while honey consumption resulted in less total adipose tissue compared to the other sweeteners, suggesting it may be a slightly better option in terms of fat accumulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding pattern, biochemical, anthropometric and histological effects of prolonged ad libitum access to sucrose, honey and glucose-fructose solutions in Wistar rats. Virgen-Carrillo, CA., Martínez Moreno, AG., Rodríguez-Gudiño, JJ., et al.[2021]

In a study involving 12 type II diabetics, honey caused a similar overall hyperglycemic effect as bread, but resulted in higher blood sugar levels at 30 minutes and lower levels at 90 minutes after consumption.

Adding fat-rich foods like almonds or cheese to honey did not change the overall hyperglycemic response, but led to increased insulin and triglyceride levels, indicating that the combination of honey with fats can affect metabolic responses differently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic effects of honey (alone or combined with other foods) in type II diabetics. Katsilambros, NL., Philippides, P., Touliatou, A., et al.[2019]

In type 2 diabetic patients, consuming 30 g of fructose resulted in a minimal increase in blood glucose levels compared to sucrose or honey, suggesting that fructose may be a safer sweetener option for managing postprandial glycemia.

Corn patoka in candies containing isomalt caused a significant rise in blood glucose, while beverages with nonnutritive sweeteners did not affect blood glucose levels, indicating that not all sweeteners have the same impact on glycemic response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative study of postprandial glycaemia in type 2 diabetic patients after consumption of mono- and disaccharides and sweeteners]. Sharafetdinov, KhKh., Meshcheriakova, VA., Plotnikova, OA., et al.[2006]

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