Fructose Diets for Prediabetes

Overseen By Jean-Marc Schwarz, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Touro University, California

Must not be taking: Anti-diabetic, Hypolipidemic

Disqualifiers: Diabetes, Liver disease, Cancer, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different fructose meals affect blood sugar and fat production in individuals with prediabetes. Participants will consume meals with varying fructose levels to observe their impact on metabolism. Those with prediabetes who have struggled with high blood sugar levels but have not been diagnosed with diabetes may be suitable candidates. Participants will try meals with different sugar labels, allowing researchers to track how the body processes them. As an unphased study, this trial provides a unique opportunity to contribute to understanding and managing prediabetes.

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

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used anti-diabetic or cholesterol-lowering drugs in the past six months.

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

Research shows that eating a moderate amount of fructose is generally safe. Studies have found that consuming less than 50 grams of fructose per day does not harm blood sugar or fat levels. Some research even suggests that eating up to 90 grams of fructose daily might help lower glycated hemoglobin (HbA1c), a marker of long-term blood sugar levels. However, excessive fructose intake can increase the risk of health problems like type 2 diabetes and affect heart health.

For low fructose diets, research indicates that keeping fructose intake under 50 grams per day is safe. This amount does not negatively impact blood fat levels and may help control blood sugar levels.

In summary, while moderate fructose consumption seems safe, excessive intake could lead to health issues. Monitoring daily fructose intake is important for maintaining health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore how different fructose levels and labeling methods affect prediabetes, which is not the focus of typical treatments like lifestyle changes or medications like metformin. By incorporating 2-13C fructose or 2-13C pyruvate into meals, these treatments allow scientists to track how fructose and pyruvate are metabolized in the body, offering new insights into metabolic processes. Unlike standard approaches that focus on lowering blood sugar levels, these novel treatments aim to understand the underlying metabolic pathways, potentially paving the way for more targeted interventions in managing prediabetes.

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

This trial will compare different fructose diets for individuals with prediabetes. Studies have shown that using fructose instead of glucose or sucrose can lower blood sugar levels after meals, especially in people with prediabetes. Participants in this trial will receive either high or low fructose meals, with some meals labeled with fructose and others with pyruvate. When participants consumed meals with less fructose, their blood sugar and other health markers improved over time. However, excessive fructose intake can worsen diabetes and related issues. Large amounts of fructose can also affect the heart and increase the risk of type 2 diabetes. These findings suggest that the amount and type of fructose in a diet can influence blood sugar control and overall health. ^{1 3 6 7 8}

Who Is on the Research Team?

Jean-Marc Schwarz, PhD

Principal Investigator

Touro University, California

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 22-35 who are either healthy, prediabetic (HbA1c between 5.7% and 6.5%), or have high fasting insulin but not diabetes. Participants should not have had significant weight changes recently, be free from liver disease, hepatitis, HIV, cancer history, and cannot be pregnant or on certain medications.

Inclusion Criteria

I am prediabetic or have high insulin but not diabetic.

Your body mass index (BMI) is between 22 and 35.

Your fasting insulin, fasting glucose, and HbA1c levels are within specific normal ranges.

Exclusion Criteria

Pregnancy or lactation within the past six months

You have hepatitis or HIV infection.

Known intolerance to acetaminophen or components of the liquid test meals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume meals with varying fructose content and labeled compounds to study metabolic effects

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High fructose, fructose labeled meal
• High fructose, pyruvate labeled meal
• Low fructose, fructose labeled meal
• Low fructose, pyruvate labeled meal

Trial Overview The study aims to understand how fructose in meals affects fat synthesis and blood sugar levels by comparing the effects of meals with different fructose content and labeling (either low or high fructose labeled with pyruvate). The participants' response to these meals will help clarify fructose's role in metabolism.

How Is the Trial Designed?

Group I: Low fructose meal, with pyruvate label Experimental Treatment 1 Intervention

2-13C pyruvate incorporated into a meal with low fructose content

Group II: Low fructose meal, with fructose label Experimental Treatment 1 Intervention

2-13C fructose incorporated into a meal with low fructose content

Group III: High fructose meal, with pyruvate label Experimental Treatment 1 Intervention

2-13C pyruvate incorporated into a meal with high fructose content

Group IV: High fructose meal, with fructose label Experimental Treatment 1 Intervention

2-13C fructose incorporated into a meal with high fructose content

Who Is Running the Clinical Trial?

Touro University, California

Lead Sponsor

Trials

8

Recruited

1,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2991323/

Health implications of fructose consumption - PubMed Central It has been considered that moderate fructose consumption of ≤50g/day or ~10% of energy has no deleterious effect on lipid and glucose control and of ≤100g/day ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1043661825003391

The efficacy of dietary interventions for prediabetes ... Fructose replacement significantly reduced postprandial plasma glucose levels compared to glucose (SMD: −8.275, 95 % CI: −12.663 to −3.887) and sucrose (SMD: − ...

3. mayoclinicproceedings.org mayoclinicproceedings.org/article/s0025-6196(15)00040-3/fulltext

Added Fructose Intake of added fructose at such high levels would undoubtedly worsen rates of diabetes and its complications. There is no need for added ...

4. heart.org heart.org/en/news/2019/04/15/study-massive-health-gains-from-new-food-labels-with-sugar-details

Study: Massive health gains from new food labels with ... New nutrition labels listing added sugars on packaged foods and drinks could prevent nearly a million cases of cardiovascular disease and Type 2 diabetes in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2714385/

Dietary Fructose and Metabolic Syndrome and Diabetes Studies in both healthy and diabetic subjects demonstrated that fructose produced a smaller postprandial rise in plasma glucose and serum insulin than other ...

6. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)23346-8/fulltext

How safe is fructose for persons with or without diabetes?12 They concluded that fructose is safe at doses of <90 g/d and that it may have the added benefit of lowering concentrations of glycated hemoglobin (HbA1c). This ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023061042

The impact of dietary fructose on gut permeability ... Dietary high-fructose can increase intestinal permeability and circulatory endotoxin by changing the gut barrier function and microbial composition.

8. researchgate.net researchgate.net/publication/23461391_How_safe_is_fructose_for_persons_with_or_without_diabetes

How safe is fructose for persons with or without diabetes? However, a fructose intake below 60 g/day, corresponding to 4-5 kg/day of cultivated pineapples, is considered to be safe (Sanchez-Lozada et al.