11 Participants Needed

High Fructose Diet for Obesity

RW
RW
Overseen ByRyan Walker
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a diet high in fructose, a type of sugar, affects gut health and its connection to metabolic issues like insulin resistance and type 2 diabetes. Participants will follow a special diet that includes either high fructose or high glucose meals for a set period to observe the effects on the gut microbiome (the community of microbes in the intestines) and overall metabolic health. The trial aims to uncover how changes in the gut caused by fructose might increase the risk of metabolic diseases. The study seeks individuals who have trouble absorbing fructose (fructose malabsorbers), identifiable through a specific breath test. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on diet and metabolic health.

Will I have to stop taking my current medications?

The trial excludes participants who are on chronic medications that affect body weight, insulin resistance, or lipid profiles. If you are taking such medications, you may need to stop them to participate in the trial.

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

Research has shown that consuming high amounts of fructose, a type of sugar, can impact health in various ways. One study found that women on a high fructose diet had lower blood sugar but higher triglyceride levels, which could increase heart disease risk. Another study discovered that high fructose intake can lead to increased liver fat and insulin issues, linked to diabetes and other health problems.

These studies suggest potential risks, but not everyone will experience these issues. Those considering a trial involving a high fructose diet should be aware of possible changes in blood fat levels and liver health. Consulting a healthcare provider is advisable for any concerns about this type of diet.12345

Why are researchers excited about this trial?

Researchers are excited about the high fructose diet for obesity because it explores a unique dietary approach rather than conventional treatments like lifestyle changes, medications, or surgery. Unlike typical methods that often focus on reducing calorie intake or increasing calorie burn, this study examines the effects of specific types of sugars—fructose and glucose—on weight maintenance. By alternating between high fructose and high glucose diets, researchers hope to uncover how these sugars might differently impact weight and metabolism, potentially paving the way for more targeted dietary strategies for managing obesity.

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

Research has shown that consuming a lot of fructose, a type of sugar, links to health problems. Studies have found that fructose can impair the body's ability to control sugar levels, increasing the risk of type 2 diabetes. In animal studies, diets high in fructose led to fat buildup in the liver and higher blood fat levels, both associated with obesity and other health issues. Although evidence in humans is less clear, it suggests that excessive fructose intake can cause similar problems, such as poor liver function and unhealthy blood fat levels. This trial will compare the effects of a high fructose diet with a high glucose diet on these health markers. These findings highlight the potential negative effects of consuming too much fructose.14567

Who Is on the Research Team?

RW

Ryan Walker

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults with Type 2 Diabetes, Mesenteric Artery Stenosis, or Obesity. Participants will be tested on how a high fructose diet versus a glucose diet affects their gut microbiome and metabolic health. They should not have conditions that interfere with the study's dietary requirements.

Inclusion Criteria

Participants must be determined to be a fructose malabsorber via hydrogen breath test

Exclusion Criteria

Consumption of > 1 sugar sweetened beverage per day
Use of probiotic/prebiotic/synbiotic supplements
Vegetarian, vegan or other restrictive dietary habits
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants consume a 12-day isocaloric high fructose diet followed by a 12-day isocaloric high glucose diet, with a 10-day washout period in between

34 days

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • High Fructose Diet
Trial Overview The study tests the effects of a controlled high fructose diet compared to a glucose diet on participants' gut bacteria and metabolism. It involves consuming specific diets for 12 days, followed by a washout period, then switching diets. The impact on liver fat and diabetes risk markers will also be studied using advanced techniques like MRI elastography.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Glucose Dietary then Fructose DietaryExperimental Treatment2 Interventions
Group II: Fructose Dietary then Glucose DietaryExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Metabolic Solutions Inc.

Industry Sponsor

Trials
5
Recruited
180+

Published Research Related to This Trial

In a study of 131 obese patients over 6 weeks, a moderate natural fructose diet led to greater weight loss (4.19 kg) compared to a low-fructose diet (2.83 kg), suggesting that not all fructose is equally harmful.
Both diets resulted in significant improvements in metabolic syndrome parameters, indicating that reducing energy and added fructose intake can be an effective strategy for combating obesity and diabetes.
The effect of two energy-restricted diets, a low-fructose diet versus a moderate natural fructose diet, on weight loss and metabolic syndrome parameters: a randomized controlled trial.Madero, M., Arriaga, JC., Jalal, D., et al.[2017]
In a review of 31 isocaloric trials with 637 participants, fructose did not significantly affect body weight when substituted for other carbohydrates in diets with the same calorie content.
However, in 10 hypercaloric trials with 119 participants, high doses of fructose (providing excess calories) led to modest weight gain, suggesting that the increase in weight may be due to the extra calories rather than fructose itself.
Effect of fructose on body weight in controlled feeding trials: a systematic review and meta-analysis.Sievenpiper, JL., de Souza, RJ., Mirrahimi, A., et al.[2022]
In a study involving 17 monkeys on a high-fructose diet for up to 7 years, those allowed to eat freely developed hepatic steatosis (HS) and increased diabetes incidence, indicating that long-term fructose consumption can lead to significant liver fat accumulation and metabolic issues.
Even without weight gain, monkeys on a controlled high-fructose diet for 6 weeks showed liver damage and increased markers of endotoxemia and microbial translocation, suggesting that fructose can harm liver health rapidly through mechanisms unrelated to obesity.
Dietary fructose induces endotoxemia and hepatic injury in calorically controlled primates.Kavanagh, K., Wylie, AT., Tucker, KL., et al.[2023]

Citations

Health implications of fructose consumption - PubMed CentralAn increase in high fructose corn syrup, as well as total fructose, consumption over the past 10 to 20 years has been linked to a rise in obesity and metabolic ...
Fructose, weight gain, and the insulin resistance syndromeFructose consumption induces insulin resistance, impaired glucose tolerance, hyperinsulinemia, hypertriacylglycerolemia, and hypertension in animal models.
Metabolic Effects of Fructose and the Worldwide Increase ...The evidence is less compelling in humans, but high fructose intake has indeed been shown to cause dyslipidemia and to impair hepatic insulin ...
Fructose Consumption in the Development of Obesity and ...Recently, an important study with primates showed that diets rich in fructose were able to induce a hepatic steatosis stage, with lipid droplet size positively ...
Health outcomes of a high fructose intake: the importance of ...It has indeed been well documented that de novo lipogenesis was increased after 6 days on a hypercaloric, high fructose diet (Faeh et al.
Fructose Consumption in the Development of Obesity and the ...Studies indicate that fructose may be a carbohydrate with greater obesogenic potential than other sugars. In this context, the liver seems to be ...
Health Implications of High-Fructose Intake and Current ...A clinical trial conducted in 12 women showed that an isocaloric diet with a high fructose content resulted in lower blood glucose and higher serum TGs than a ...
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