Effect of Isoflavone and Vitamin D Supplementation on Serum Vitamin D Levels, Body Composition, I… (NCT07656233) | Clinical Trial Compass
CompletedNot Applicable
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
Indonesia50 participantsStarted 2025-11-17
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a combination of isoflavones and vitamin D supplements in people with ulcerative colitis or Crohn's disease — given that it's now completed, has any data been published yet, and do the results suggest this combination had any meaningful effect on inflammation markers like TNF-α or IL-10 in people with a situation like mine?
2The trial ran for only 8 weeks — is that long enough to know whether these supplements could have lasting benefits for IBD, or does the short timeframe limit how much we can take away from the findings?
3The trial tracked muscle mass using something called the appendicular skeletal muscle index — is muscle loss actually a concern for me given my diagnosis, and should we be monitoring that as part of my care regardless of what this trial found?
4Since this study was classified as 'phase NA,' meaning it wasn't a standard drug trial testing safety and dosing in stages, how confident can we be in the safety of combining isoflavone and vitamin D supplements at the doses used, especially given my specific IBD medications or health history?
5Before considering anything from this trial, would you recommend I focus first on getting my vitamin D levels checked, since the study measured changes starting from baseline — and do you think my current levels might be low enough that supplementation alone is worth discussing as part of my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in serum 25-hydroxyvitamin D levels between baseline and week 8
Timeframe: Baseline and week 8
2
Change in serum tumor necrosis factor-alpha (TNF-α) levels between baseline and week 8
Timeframe: Baseline and week 8
3
Change in serum interleukin (IL)-10 levels between baseline and week 8
Timeframe: Baseline and week 8
4
Change in Inflammatory Bowel Disease Questionnaire (IBDQ)-9 score between baseline and week 8
Timeframe: Baseline and week 8
5
Change in appendicular skeletal muscle index (ASMI) between baseline and week 8