Recruiting
Early Phase 1

Cranberry Supplement

Sponsor:

Ana Maldonado-Contreras

Code:

NCT07170462

Conditions

Crohn Disease (CD)

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cranberry powder

Placebo

Study Details

Brief summary:

This study is investigating whether a cranberry-based dietary supplement, rich in polyphenols and fiber, can enhance gut health in individuals with Crohn's disease. People with Crohn's disease often have an imbalance in their gut microbiome (the community of bacteria in the gut). Previous research suggests that cranberry compounds may help support beneficial gut bacteria.

In this study, adults with Crohn's disease will be randomly assigned to one of two groups: one group will receive a cranberry supplement to take once daily for 10 weeks, and the other group will receive a placebo (a supplement with no active ingredients).

All participants will be asked to complete online questionnaires and collect samples of their blood, urine, and stool at four time points over a total of 15 weeks. These samples will help researchers understand how the cranberry supplement affects the gut microbiome, inflammation, and overall health.

Participation is voluntary, and participants can withdraw from the study at any time. The results of this study may help identify new diet-based approaches to improve gut health in individuals with Crohn's disease.

Conditions

Crohn Disease (CD)

Crohn Disease

Study ID

NCT07170462

Start date

Oct 29, 2025

Status verified date

Jul, 2026

Completion date

Aug 15, 2026

Anticipated

Primary completion date

Aug 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult CD patients between 18 and 65 years old.
  • Women of childbearing potential will be required to use at least one form of "highly effective" contraception throughout the study.
  • Confirmed diagnosis of Crohn's disease.
  • CD activity lower than sCDAI<450.
  • Moderate to severely impaired Health Related Quality of life (HRQoL). sIBDQ score <60.
  • Stable dose of medications at screening; thiopurines, natalizumab, methotrexate (12 weeks), anti-TNF, ustekinumab (8 weeks), vedolizumab (8 weeks), 5-ASA (2 weeks),
  • steroids (1 week).
  • Willingness and capacity to significantly consume the cranberry supplement daily.
  • Willing and able to comply with specimen collection and other study procedures, and to complete the study.
  • Able to provide written informed consent.
  • Reside in Massachusetts, USA.

Exclusion Criteria:

  • Ostomy
  • Presence of symptomatic or significant stricture or history of obstruction in the past 6 months
  • Pregnancy
  • Use of Specific Carbohydrate Diet of IBD- AID within 4 weeks of screening
  • Use of probiotics within 4 weeks of screening
  • Use of antibiotics within 4 weeks of screening
  • > 20mg prednisone or equivalent
  • Recent C. difficile colitis
  • Unable to provide informed consent for themselves
  • Prisoners
  • Children

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cranberry

Participants in the intervention arm will be provided with 7 servings of Cranberry whole powder per week. Participants in the intervention arm are expected to consume 1 serving per day of cranberry whole powder for 10 weeks.

placebo comparator: Placebo

Participants in the placebo arm will be provided with 7 servings of placebo powder (placebo supplement matched in appearance and flavor) per week. Participants in the placebo arm are expected to consume a serving per day of placebo powder for 10 weeks.

Interventions

Cranberry powder

Cranberry whole powder equivalent to 100 g of fresh cranberries, 525 mg total (poly)phenols), and approximately 3.6 g of fiber.

Placebo

placebo powder (9 g powder, no (poly)phenols, no fibers

Primary outcome measure

  • Change in relative abundance of butyrate-producing Clostridia species, assessed with shotgun metagenomic sequencing and MetaPhlAn taxonomic profiling [ Time Frame: 15 weeks ]

Central Contacts and Locations

Central contacts

Madeline Johns

508-856-5279MadelineNunez.Johns@umassmed.edu

Locations

UMASS medical center

Recruiting

Worcester, Massachusetts, United States, 10655

Contacts

Madeline Johns

MadelineNunez.Johns@umassmed.edu

More Information

Sponsor

Ana Maldonado-Contreras

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • cranberry
  • dietary supplement
  • crohn disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ana Maldonado-Contreras on 2026-07-20.