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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

Diet is a determinant of gut microbial diversity and composition and is recognized as a potential environmental trigger for IBD; for example, high-fat diets are associated with increased risk of CD in pre-clinical models, with effects mediated through dysbiosis and altered gut permeability. Diet is also a potential non-pharmacological therapy for weight loss and for reducing the occurrence of disease flares and the reliance on dose escalation of biologic agents. Indeed, there is accumulating evidence for the role of diet in the treatment of CD, and diet-induced improvement of microbial dysbiosis is associated with induction of remission in pediatric patients with active CD. Intermittent Fasting (IF) is a dietary intervention that involves periodic intervals of no or very limited energy intake. We want to determine the efficacy and feasibility of a 12-week IF(Intermittent Fasting) intervention to induce weight loss (by 1 BMI unit reduction), decrease biomarker inflammation and increase microbial functional diversity compared to standard medical management (SM) in a pilot study of individuals with overweight or obesity and CD in clinical remission with elevated biomarkers of inflammation, indicated by fecal calprotectin (FCP) \> 250 µg/g or C-reactive protein (CRP) \> 5 mg/L).

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.

Is intermittent fasting generally safe for humans?

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 disorder symptoms was examined. Intermittent fasting during Ramadan was studied in patients with inflammatory bowel diseases, but the safety specifics were not detailed. ^{1 2 3 4 5}

How does intermittent fasting differ from other treatments for Crohn's disease?

Intermittent fasting is unique because it involves specific eating patterns, like alternate-day fasting or time-restricted eating, rather than focusing on what foods to avoid or consume, as seen in other diets like the Crohn's Disease Exclusion Diet (CDED). This approach is novel for Crohn's disease as it emphasizes meal timing rather than dietary content. ^{6 7 8 9 10}

Research Team

Maitreyi Raman, MD

Principal Investigator

University of Calgary

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Determinants of weight loss success with alternate day fasting. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effect of Ramadan intermittent fasting on inflammatory markers, disease severity, depression, and quality of life in patients with inflammatory bowel diseases: A prospective cohort study. [2022]

5. England 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Modified Crohn's disease exclusion diet is equally effective as exclusive enteral nutrition: Real-world data. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Food avoidance and fasting in patients with inflammatory bowel disease: Experience from the Nancy IBD nutrition clinic. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Crohn's Disease Exclusion Diet for the Treatment of Crohn's Disease: Real-World Experience from a Tertiary Center. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Is fasting beneficial for hospitalized patients with inflammatory bowel diseases? [2020]