Intermittent Fasting for Weight Loss in Crohn's Disease

(CD-Fast Trial)

Overseen By Maitreyi Raman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Antibiotics, Corticosteroids

Disqualifiers: Upper GI CD, Fistulizing, Strictures, Colectomy, Ostomy, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if intermittent fasting (regular periods of limited food intake) can help people with Crohn's disease lose weight and reduce inflammation. Participants will either follow a fasting schedule or maintain their usual eating habits. The trial seeks individuals who have been in remission from Crohn's disease but still show signs of inflammation, are overweight, and have not changed medications for at least three months. As an unphased trial, this study provides a unique opportunity to explore new lifestyle interventions for managing Crohn's disease symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that your medication doses have been stable for at least 3 months before joining. This means you should not change your current medications before starting the trial.

What prior data suggests that intermittent fasting is safe for individuals with Crohn's disease?

Research has shown that intermittent fasting (IF) is generally safe for most people. Studies on various types of IF, such as fasting every other day, indicate it is usually well-tolerated, with no major side effects reported.

One study found that IF can reduce inflammation markers, like CRP, in healthy individuals. This reduction might benefit those with Crohn's Disease, which involves inflammation. Other research suggests that IF could aid individuals with chronic inflammatory conditions, such as liver and heart diseases.

Overall, evidence suggests that IF can be a safe way to lose weight and manage inflammation. However, like any diet plan, it might not be suitable for everyone. Discussing any new diet or treatment with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Crohn's Disease focus on medication to reduce inflammation and manage symptoms, like corticosteroids or immunosuppressants. However, intermittent fasting is unique because it explores a non-drug approach to potentially manage weight loss and symptoms. This method involves fasting for a set period, which might help reset the gut's balance and reduce inflammation naturally. Researchers are excited about this trial because it could offer a complementary lifestyle option that might enhance quality of life without the side effects associated with long-term medication use.

What evidence suggests that intermittent fasting might be an effective treatment for Crohn's disease?

Research has shown that intermittent fasting (IF), which involves eating only during specific hours and fasting the rest of the time, can help individuals who are overweight or obese lose weight. Studies have found that IF can result in a weight loss of 4% to 10% over 4 to 24 weeks. This trial will compare an IF regimen, where participants fast for 16 consecutive hours on 6 days per week, with a standard medical care group that maintains their usual dietary pattern. This eating approach might also improve health by reducing inflammation and enhancing gut health. IF offers similar benefits to traditional calorie-restricted diets, making it a promising option for those seeking to manage their weight and potentially alleviate Crohn's disease symptoms. Although more research is needed, current evidence supports IF as an effective method for weight loss and health improvement. ^{6 7 8 9 10}

Who Is on the Research Team?

Maitreyi Raman, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with Crohn's Disease in remission and a BMI over 25, indicating overweight or obesity. Participants must have inflammation shown by specific blood or stool tests and be on stable medication doses without recent steroid use, surgery, or antibiotics.

Inclusion Criteria

My medication for inflammation or immune response has been stable for 3 months.

You are considered overweight or obese with a body mass index (BMI) greater than 25 and have a good nutritional status according to a special assessment.

presence of inflammation using an FCP ≥ 250 µg/g or a CRP ≥ 5 mg/L

Exclusion Criteria

I have had more than one surgery to remove parts of my small intestine.

I have had a test in the last year showing narrowing in my intestines.

My Crohn's disease affects my upper GI tract and has caused fistulas.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo a 12-week Intermittent Fasting intervention or continue with Standard Medical Care

12 weeks

Bi-weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Fasting

Trial Overview The study examines if Intermittent Fasting (IF) can help reduce weight by at least one BMI unit and improve gut health compared to standard medical care. Over 12 weeks, the effects of IF on weight loss, inflammation markers, and microbial diversity in the gut will be measured.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

The IF group will fast for 16 consecutive hours on 6 days per week with an 8-hour eating window (e.g., eat from 10 a.m. to 6 p.m.). The IF group will consume their habitual diet in terms of food choices and energy intake, but only during the 8-hour and full-day non-fasting periods. An RD will meet virtually with participants in the IF group at baseline to teach them the fasting protocol and how to manage energy intake and hunger, as well as to reinforce the requirement to not change habitual dietary practices. The research coordinator will call patients every two weeks to assess for changes in medications, compliance with the fasting protocol, and symptoms (assessed monthly) using the modified HBI.

Group II: Standard Medical Care Group Active Control 1 Intervention

The control group will continue with their habitual dietary pattern. The research coordinator will call patients at baseline and every two weeks to assess for changes in medications and symptoms (assessed monthly) using the modified HBI.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Crohn's and Colitis Foundation

Collaborator

Trials

44

Recruited

27,500+

Published Research Related to This Trial

In a study of 434 patients with inflammatory bowel disease (IBD), about 36.6% totally excluded at least one food category, and 62.4% partially excluded foods, indicating a significant prevalence of exclusion diets among these patients.

Approximately 30.8% of patients reported some form of fasting, with disease activity and specific treatments being linked to both exclusion diets and fasting behaviors, suggesting that dietary management could play a crucial role in their clinical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food avoidance and fasting in patients with inflammatory bowel disease: Experience from the Nancy IBD nutrition clinic. Bonsack, O., Caron, B., Baumann, C., et al.[2023]

In a study of 194 patients with mild to moderate Crohn's disease, the Specific Carbohydrate Diet (SCD) did not show superior effectiveness compared to the Mediterranean Diet (MD) in achieving symptomatic remission after 6 weeks, with remission rates of 46.5% for SCD and 43.5% for MD (P = .77).

Both diets resulted in low rates of fecal calprotectin (FC) and C-reactive protein (CRP) responses, indicating limited effectiveness in reducing inflammation, and given the ease of following the MD and its additional health benefits, it may be the preferred option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. Lewis, JD., Sandler, RS., Brotherton, C., et al.[2022]

In a study of 271 patients with non-alcoholic fatty liver disease (NAFLD), alternate-day fasting (ADF) led to significant weight loss and fat mass reduction within just 4 weeks, with continued improvements over 12 weeks.

ADF also resulted in a notable decrease in total cholesterol and triglycerides, indicating its potential effectiveness in improving lipid profiles in NAFLD patients, although further research is needed to confirm its long-term cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of alternate-day fasting on body weight and dyslipidaemia in patients with non-alcoholic fatty liver disease: a randomised controlled trial. Cai, H., Qin, YL., Shi, ZY., et al.[2020]

In an 8-week study with 59 obese participants, alternate day fasting (ADF) led to a significant weight loss of 4.2%, while only a small percentage reported mild adverse effects like constipation and dizziness.

ADF was associated with improvements in eating disorder symptoms, including a decrease in depression and binge eating, suggesting that it may have beneficial effects on body image and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

Alternate-day fasting (ADF) is a safe and well-tolerated weight loss method, with 93% of participants completing the 8-week study without adverse effects.

While ADF and a standard caloric restriction diet produced similar weight loss results after 8 weeks, ADF showed more favorable changes in body composition, particularly in fat and lean mass, during the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. Catenacci, VA., Pan, Z., Ostendorf, D., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10098946/

A meta‐analysis comparing the effectiveness of alternate day ... Our results ranked alternate day fasting/modified ADF as the regimen with the highest efficacy for weight loss compared with the 5:2 diet and ...

2. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-53702400098-1/fulltext

Intermittent fasting and health outcomes: an umbrella ... Our findings suggest that IF may have beneficial effects on a range of health outcomes for adults with overweight or obesity, compared to CER or ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9946909/

Beneficial effects of intermittent fasting: a narrative review According to previous clinical trials [10,47] and reviews [14,48-50], IF (4–24 weeks) induces body weight reductions of 4% to 10% in overweight individuals [51- ...

4. bmj.com bmj.com/content/389/bmj-2024-082007

Intermittent fasting strategies and their effects on body ... The current evidence provides some indication that intermittent fasting diets have similar benefits to continuous energy restriction for weight loss and ...

5. hsph.harvard.edu hsph.harvard.edu/news/intermittent-fasting-may-be-effective-for-weight-loss-cardiometabolic-health/

Intermittent fasting may be effective for weight loss ... Researchers found that for weight loss, intermittent fasting and traditional calorie-restricted diets were on par and were more effective than ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11597193/

Effect of Intermittent Fasting on Immune Parameters and ... TRE and ADF appear to have anti-inflammatory effects in healthy individuals, as they significantly reduce CRP levels and inflammatory markers.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/apt.18214

Review article: Evidence‐based dietary management of ... However, over 50% of patients did not complete the six-session intervention and adherence to a low UPF diet was poor beyond 4 months of ...

8. ijns.sums.ac.ir ijns.sums.ac.ir/article_51115_95de2ab6167f88b6e977f7f1c3ae8578.pdf

Unlocking the Potential of Intermittent Fasting as a Dietary ... IF was shown to have positive effects on chronic inflammatory diseases, such as non-alcoholic fatty liver disease and cardiovascular disorders.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10240551/

A review of the role of intermittent fasting ... The aim of this short narrative review is to summarize the evidence related to IF in the management of IBD.

10. withpower.com withpower.com/trial/phase-weight-loss-2-2022-fc94e

Intermittent Fasting for Weight Loss in Crohn's Disease (CD ... Studies on alternate-day fasting (ADF) show it is generally safe for weight loss, with no significant adverse events reported, although its impact on eating ...