NCT07656233Completed
Effect of Isoflavone and Vitamin D Supplementation on Serum Vitamin D Levels, Body Composition, Inflammatory Markers, and Quality of Life in Patients With Inflammatory Bowel Disease
Effect of Isoflavone and Vitamin D Supplementation on Serum Vitamin D Levels, Body Composition, Inflammatory Markers, and Quality of Life in Patients With Inflammatory Bowel Disease: An Open-Label Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
Inflammatory bowel disease (IBD) is a chronic immune-mediated disorder characterized by recurrent intestinal inflammation, impaired nutritional status, and reduced quality of life. Nutritional deficiencies and alterations in body composition are frequently observed in patients with IBD and may contribute to disease burden and long-term complications. Isoflavones derived from fermented soy products, such as tempeh, have demonstrated anti-inflammatory properties in both experimental and clinical studies. Vitamin D is an important immunomodulatory nutrient, and its deficiency is common in patients with IBD. However, evidence regarding the combined effects of isoflavone and vitamin D supplementation on inflammatory markers, nutritional status, and quality of life in patients with IBD remains limited. This study aimed to evaluate the effects of daily tempeh powder supplementation providing approximately 50 mg of isoflavones and 4000 IU of vitamin D3 for 8 weeks in patients with IBD. Outcomes include changes in serum vitamin D concentration, body composition parameters, serum tumor necrosis factor-alpha (TNF-α), interleukin-10 (IL-10), and quality of life assessed using the Inflammatory Bowel Disease Questionnaire-9 (IBDQ-9).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 5 Jun 2026
- Start date
- 17 Nov 2025
- Primary completion date
- 19 Jan 2026
- Lead sponsor
- Universitas Indonesia
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07656233
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 17 Nov 2025 to the primary completion date, 19 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Vegetarian, diagnosed as unclassifed IBD, patient with severe clinical manifestation requiring immediate medical management, with other diagnosed gastrointestinal diseases, pregnancy or lactation, severe hepatic impairment, with implant, with amputation of at least one extremity, with active infectious skin wounds or lesions.
Who the study is looking for
- Male or female adults aged ≥18 years, diagnosed with inflammatory bowel disease including ulcerative colitis or Crohn's disease, receiving standard medical therapy for IBD, willing to provide written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia Coordinator of this site? Confirm its status | Jakarta Pusat | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.