40 Participants NeededMy employer runs this trial

High Protein, High Fiber Diet for Ulcerative Colitis

LC
Overseen ByLulu Chen
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
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 special diet, high in both protein and fiber, can benefit people with ulcerative colitis (UC). Researchers aim to determine if this diet meets the higher protein needs of UC patients while reducing harmful gut bacteria. Participants will alternate weekly between their normal diet and the high-protein, high-fiber diet. This trial may suit individuals who have had UC for at least three months and are not taking strong medications like antibiotics. As an unphased trial, it provides a unique opportunity to contribute to understanding dietary impacts on UC without the constraints of traditional drug testing phases.

Will I have to stop taking my current medications?

The trial requires that you are on a stable dose or no existing UC therapies, except for steroids, for specific periods before joining. This means you may need to continue your current medications if they meet the stability requirements.

What prior data suggests that this diet is safe for ulcerative colitis patients?

Research has shown that a diet high in fiber might help protect people with ulcerative colitis. Studies have found that low-fiber diets, common in Western countries, can worsen symptoms. This suggests that a diet rich in protein and fiber might be more manageable for those with this condition.

Specific information about negative effects from a high-protein, high-fiber diet for ulcerative colitis is lacking. However, similar diets have not shown any harmful effects. Overall, evidence suggests that this type of diet could safely help manage ulcerative colitis symptoms.12345

Why are researchers excited about this trial?

Most treatments for ulcerative colitis involve medications that reduce inflammation, like corticosteroids or aminosalicylates. However, researchers are excited about the high-protein, high-fiber (HPHF) diet because it offers a non-drug approach that could complement or even enhance existing treatments. Unlike medications, which often have side effects, this diet intervention could improve gut health naturally by providing nutrients that support the body's own healing processes. This dietary approach may offer a fresh avenue for managing symptoms and improving quality of life for those with ulcerative colitis.

What evidence suggests that this high protein, high fiber diet might be an effective treatment for ulcerative colitis?

Research has shown that a high-fiber diet can improve life for people with ulcerative colitis (UC), even when symptoms are inactive. One study found that individuals following this diet were less likely to experience a return of symptoms. A diet low in fat and high in fiber can help reduce inflammation, the body's response to harmful stimuli. Increasing soluble fiber intake, found in foods like oatmeal and apples, might help lessen UC symptoms. However, strong evidence does not support that diets high in both protein and fiber directly reduce UC risks. While some benefits are noted, more high-quality research is needed to confirm these effects. Participants in this trial will alternate between a standard diet and a high-protein, high-fiber diet to evaluate its effects on UC symptoms.678910

Who Is on the Research Team?

LT

Levi Teigen

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults (18+) diagnosed with ulcerative colitis for at least 3 months, whose disease is mild to moderate and stable. Participants must be able to give consent and have been on the same UC treatment or no treatment (except steroids) for a set period before joining.

Inclusion Criteria

* Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization
I am on a stable dose or not taking UC medications, except for steroids.
I have not taken any medication or only 5-ASA for at least 4 weeks.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow an on-off cycling diet intervention alternating between a standard diet and a high-protein, high-fiber diet

4 weeks
Weekly visits for diet monitoring and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • High Protein, High Fiber (HPHF) Diet

Trial Overview

The study tests a special high-protein, high-fiber diet designed to meet protein needs in people with ulcerative colitis while reducing harmful substances made by gut bacteria. The effects of this diet will be monitored over time.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: On-Off Cycling InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

Diet and Nutrition in Inflammatory Bowel Disease: A Review of ...

Most patients experienced no significant difference between the diets, including no difference in IBD symptoms or fecal calprotectin levels.45 ...

High fiber diet may improve the quality of life for patients ...

Eating diets low in fat and high in fiber may improve the quality of life of patients with ulcerative colitis (UC) - even those in remission ...

Diet and Ulcerative Colitis: What the Evidence Shows

They found that those patients who adhered to this diet were much less likely to have a clinical relapse: 19.2%, for example, compared to 29.6% ...

Low-Fat, High-Fiber Diet Reduces Markers of Inflammation ...

A high-fat diet has been associated with an increased risk of ulcerative colitis (UC). We studied the effects of a low-fat, high-fiber diet (LFD) vs an ...

A Practical Approach to Integration of Diet and Nutrition in ...

In addition, mechanistically such diets may be beneficial in preventing IBD relapses though high-quality data on this is lacking. In the absence ...

Diet as a risk factor for the development of ulcerative colitis

a high fiber diet and high intake of fruits and vegetables may play a protective effect. increase the risk of IBD, undifferentiated for ulcerative colitis or ...

Do Ultra-processed Foods Impact Ulcerative Colitis?

diets high in processed foods and low in fiber, characteristic of the Western diet, have been associated with increased disease activity and poorer outcomes in ...

Pro-Inflammatory Diets May Increase Risk for Crohn Disease

Diets with high inflammatory potential are associated with an increased risk for Crohn disease but not of ulcerative colitis (UC), researchers ...

Impact of Diet on Inflammatory Bowel Disease Symptoms

Diet was perceived as a symptom trigger by 59.8% of subjects, and 45.4% had tried using diet as a treatment for symptom resolution, often without physician ...

Second Line Induction Therapy and Healthy Diet for ...

Secondary outcomes will be improvement in fecal calprotectin and C-reactive protein levels. plant based high fiber diet that mimics fasting