Ulcerative Colitis (UC)NCT07656233
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
A study testing Standard medical treatment, Tempeh Isoflavone and Vitamin D (Cholecalciferol ) in people with Ulcerative Colitis (UC) and Crohn Disease (CD), run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Inflammatory bowel disease (IBD) is a chronic immune-mediated disorder characterized by recurrent intestinal inflammation, impaired nutritional status, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC), Crohn Disease (CD)
- What is being tested?
- Standard medical treatment, Tempeh Isoflavone and Vitamin D (Cholecalciferol )
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Nov 2025to 25 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: 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
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).
Read the detailed description
Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), has emerged as a growing global health problem. Although historically more prevalent in Western countries, the incidence and prevalence of IBD have substantially increased throughout Asia over the past decade. The disease is characterized by chronic relapsing inflammation resulting from dysregulated interactions among genetic susceptibility, environmental factors, gut microbiota, and the immune system.
Several lifestyle and dietary factors have been implicated in disease pathogenesis. High-fat and refined-carbohydrate dietary patterns may promote pro-inflammatory responses, impair intestinal barrier function, alter mucus production, and contribute to gut microbial dysbiosis. Many patients experience recurrent disease activity despite clinical remission, highlighting the need for adjunctive strategies that may support long-term disease management.
Malnutrition is a common complication of IBD that encompasses a broad spectrum of nutritional disturbances. Patients may experience lean body mass loss, micronutrient deficiencies, protein depletion, altered hydration status, and reduced physical performance. Conversely, excessive adiposity and changes in fat distribution may also occur and can contribute to ongoing immune activation. Therefore, nutritional status assessment and composition measurements may provide a comprehensive evaluation than body mass index (BMI) alone.
Isoflavones are naturally occurring phytoestrogens found in soy-based foods. Fermentation of soybeans into tempeh increases isoflavone bioavailability by converting glycoside forms into more biologically active aglycones while reducing antinutritional factors. Emerging evidence suggests that isoflavones may modulate inflammatory pathways and influence cytokine production, including tumor necrosis factor-alpha (TNF-α), a key mediator involved in intestinal inflammation.
Vitamin D has important functions beyond skeletal health and participates in immune regulation through its effects on both innate and adaptive immune responses. Vitamin D deficiency is frequently observed in patients with inflammatory bowel disease and has been associated with poorer clinical outcomes. Previous studies have reported improvements in disease activity scores, quality of life, and vitamin D status following supplementation, although data regarding its effects on inflammatory cytokines remain limited.
The balance between proinflammatory and anti-inflammatory cytokines is central to the pathogenesis of IBD. TNF-α promotes inflammatory signalling, leukocyte recruitment, epithelial injury, and immune dysregulation. In contrast, interleukin-10 (IL-10) is a major anti-inflammatory cytokine that suppresses excessive immune responses and contributes to intestinal immune homeostasis. The evaluation of both cytokines may provide insight into the immunologic effects of nutritional interventions.
Quality of life is an important patient-centred outcome in IBD because the disease burden extends beyond gastrointestinal symptoms to include fatigue, emotional well-being, and social functioning. The validated Inflammatory Bowel Disease Questionnaire-9 (IBDQ 9) offers a practical assessment of health-related quality of life and has demonstrated good reliability in Indonesian patients.
This study aimed to investigate the effects of an 8-week nutritional intervention consisting of tempeh powder providing approximately 50 mg of isoflavones per day combined with vitamin D3 supplementation at a dose of 4,000 IU per day in patients with IBD. The study will assess changes in serum vitamin D levels, body composition indicators, inflammatory biomarkers (TNF-α and IL-10), and quality-of-life scores using the IBDQ-9. The findings of this study are expected to contribute to the development of evidence-based nutritional strategies that complement standard medical therapy and support the overall management of patients with IBD.
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD)
- Being tested
- Standard medical treatment, Tempeh Isoflavone, Vitamin D (Cholecalciferol )
- Keywords
- isoflavones, tempeh, vitamin D, inflammatory bowel disease, body composition, TNF-alpha, IL-10
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard medical treatmentOther
Participants do not receive tempeh powder of isoflavone and vitamin D. They receive standard medical therapy of IBD
Tempeh IsoflavoneDietary supplement
Participants receive 50 gram/day of tempeh powder providing approximately 50 mg of isoflavones, administered orally for 8 weeks in addition to standard medical therapy.
Vitamin D (Cholecalciferol )Dietary supplement
Participants receive oral supplementation of vitamin D3 4000 IU/day , administered orally for 8 weeks in addition to standard medical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Tempeh Isoflavone and vitamin D | Experimental | Participants receive 50 gram/day tempeh powder providing approximately 50 mg isoflavones and oral supplementation of vitamin D3 4000 IU/day for 8 weeks in addition to standard therapy. Receives: Other: Standard medical treatment; Dietary Supplement: Tempeh Isoflavone; Dietary Supplement: Vitamin D (Cholecalciferol ) |
| Standard Therapy | Active comparator | Participants receive standard medical therapy for inflammatory bowel disease for 8 weeks. Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum 25-hydroxyvitamin D levels between baseline and week 8
Serum 25-hydroxyvitamin D levels, measured in ng/mL, will be assessed at baseline and week 8. The change both from baseline and week 8 will be compared between the intervention and control groups.
Measured: Baseline and week 8
Change in serum tumor necrosis factor-alpha (TNF-α) levels between baseline and week 8
Serum TNF-α levels, measured in pg/mL, will be assessed at baseline and week 8. The change both from baseline and week 8 will be compared between the intervention and control groups.
Measured: Baseline and week 8
Change in serum interleukin (IL)-10 levels between baseline and week 8
Serum IL-10 levels, measured in pg/mL, will be assessed at baseline and week 8. The change both from baseline and week 8 will be compared between the intervention and control groups.
Measured: Baseline and week 8
Change in Inflammatory Bowel Disease Questionnaire (IBDQ)-9 score between baseline and week 8
Score of IBDQ-9, range: 0-100, will be assessed at baseline and week 8. The change both from baseline and week 8 will be compared between the intervention and control groups.
Measured: Baseline and week 8
Change in appendicular skeletal muscle index (ASMI) between baseline and week 8
Body composition will be assessed using bioelectrical impedance analysis (BIA) with electrodes placed on both hands and feet. Appendicular skeletal muscle mass will be expressed as the Appendicular Skeletal Muscle Index (ASMI, kg/m²), calculated as the sum of skeletal muscle mass in the right arm, left arm, right leg, and left leg (kg) divided by height squared (m²).
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start17 Nov 2025
- Primary completion19 Jan 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into intervention and control groups. The intervention group will receive tempeh powder and vitamin D supplementation in addition to standard therapy, while the control group will receive standard therapy without placebo according to the study protocol.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krisadelfa Sutanto, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656233
- Sponsor's protocol ID
- 25-05-0719
- Status last verified
- May 2026
- First submitted
- 5 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to confidentiality and privacy considerations
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07656233
- Acronym / sponsor ID
- 25-05-0719
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD)
- Keywords
- isoflavones, tempeh, vitamin D, inflammatory bowel disease, body composition, TNF-alpha, IL-10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), has emerged as a growing global health problem. Although historically more prevalent in Western countries, the incidence and prevalence of IBD have substantially increased throughout Asia over the past decade. The disease is characterized by chronic relapsing inflammation resulting from dysregulated interactions among genetic susceptibility, environmental factors, gut microbiota, and the immune system.
Several lifestyle and dietary factors have been implicated in disease pathogenesis. High-fat and refined-carbohydrate dietary patterns may promote pro-inflammatory responses, impair intestinal barrier function, alter mucus production, and contribute to gut microbial dysbiosis. Many patients experience recurrent disease activity despite clinical remission, highlighting the need for adjunctive strategies that may support long-term disease management.
Malnutrition is a common complication of IBD that encompasses a broad spectrum of nutritional disturbances. Patients may experience lean body mass loss, micronutrient deficiencies, protein depletion, altered hydration status, and reduced physical performance. Conversely, excessive adiposity and changes in fat distribution may also occur and can contribute to ongoing immune activation. Therefore, nutritional status assessment and composition measurements may provide a comprehensive evaluation than body mass index (BMI) alone.
Isoflavones are naturally occurring phytoestrogens found in soy-based foods. Fermentation of soybeans into tempeh increases isoflavone bioavailability by converting glycoside forms into more biologically active aglycones while reducing antinutritional factors. Emerging evidence suggests that isoflavones may modulate inflammatory pathways and influence cytokine production, including tumor necrosis factor-alpha (TNF-α), a key mediator involved in intestinal inflammation.
Vitamin D has important functions beyond skeletal health and participates in immune regulation through its effects on both innate and adaptive immune responses. Vitamin D deficiency is frequently observed in patients with inflammatory bowel disease and has been associated with poorer clinical outcomes. Previous studies have reported improvements in disease activity scores, quality of life, and vitamin D status following supplementation, although data regarding its effects on inflammatory cytokines remain limited.
The balance between proinflammatory and anti-inflammatory cytokines is central to the pathogenesis of IBD. TNF-α promotes inflammatory signalling, leukocyte recruitment, epithelial injury, and immune dysregulation. In contrast, interleukin-10 (IL-10) is a major anti-inflammatory cytokine that suppresses excessive immune responses and contributes to intestinal immune homeostasis. The evaluation of both cytokines may provide insight into the immunologic effects of nutritional interventions.
Quality of life is an important patient-centred outcome in IBD because the disease burden extends beyond gastrointestinal symptoms to include fatigue, emotional well-being, and social functioning. The validated Inflammatory Bowel Disease Questionnaire-9 (IBDQ 9) offers a practical assessment of health-related quality of life and has demonstrated good reliability in Indonesian patients.
This study aimed to investigate the effects of an 8-week nutritional intervention consisting of tempeh powder providing approximately 50 mg of isoflavones per day combined with vitamin D3 supplementation at a dose of 4,000 IU per day in patients with IBD. The study will assess changes in serum vitamin D levels, body composition indicators, inflammatory biomarkers (TNF-α and IL-10), and quality-of-life scores using the IBDQ-9. The findings of this study are expected to contribute to the development of evidence-based nutritional strategies that complement standard medical therapy and support the overall management of patients with IBD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into intervention and control groups. The intervention group will receive tempeh powder and vitamin D supplementation in addition to standard therapy, while the control group will receive standard therapy without placebo according to the study protocol.
| Arm | Type | Receives |
|---|---|---|
| Tempeh Isoflavone and vitamin D | Experimental | Other: Standard medical treatment, Dietary Supplement: Tempeh Isoflavone, Dietary Supplement: Vitamin D (Cholecalciferol )Participants receive 50 gram/day tempeh powder providing approximately 50 mg isoflavones and oral supplementation of vitamin D3 4000 IU/day for 8 weeks in addition to standard therapy. |
| Standard Therapy | Active comparator | Other: Standard medical treatmentParticipants receive standard medical therapy for inflammatory bowel disease for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard medical treatmentParticipants do not receive tempeh powder of isoflavone and vitamin D. They receive standard medical therapy of IBD | Other | Standard Therapy, Tempeh Isoflavone and vitamin D |
| Tempeh IsoflavoneParticipants receive 50 gram/day of tempeh powder providing approximately 50 mg of isoflavones, administered orally for 8 weeks in addition to standard medical therapy. | Dietary supplement | Tempeh Isoflavone and vitamin D |
| Vitamin D (Cholecalciferol )Participants receive oral supplementation of vitamin D3 4000 IU/day , administered orally for 8 weeks in addition to standard medical therapy. | Dietary supplement | Tempeh Isoflavone and vitamin D |
Primary outcome
Change in serum 25-hydroxyvitamin D levels between baseline and week 8
Time frame: Baseline and week 8
Serum 25-hydroxyvitamin D levels, measured in ng/mL, will be assessed at baseline and week 8. The change both from baseline and week 8 will be compared between the intervention and control groups.
Change in serum tumor necrosis factor-alpha (TNF-α) levels between baseline and week 8
Time frame: Baseline and week 8
Serum TNF-α levels, measured in pg/mL, will be assessed at baseline and week 8. The change both from baseline and week 8 will be compared between the intervention and control groups.
Change in serum interleukin (IL)-10 levels between baseline and week 8
Time frame: Baseline and week 8
Serum IL-10 levels, measured in pg/mL, will be assessed at baseline and week 8. The change both from baseline and week 8 will be compared between the intervention and control groups.
Change in Inflammatory Bowel Disease Questionnaire (IBDQ)-9 score between baseline and week 8
Time frame: Baseline and week 8
Score of IBDQ-9, range: 0-100, will be assessed at baseline and week 8. The change both from baseline and week 8 will be compared between the intervention and control groups.
Change in appendicular skeletal muscle index (ASMI) between baseline and week 8
Time frame: Baseline and week 8
Body composition will be assessed using bioelectrical impedance analysis (BIA) with electrodes placed on both hands and feet. Appendicular skeletal muscle mass will be expressed as the Appendicular Skeletal Muscle Index (ASMI, kg/m²), calculated as the sum of skeletal muscle mass in the right arm, left arm, right leg, and left leg (kg) divided by height squared (m²).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to confidentiality and privacy considerations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard medical treatment, Tempeh Isoflavone and Vitamin D (Cholecalciferol ) in people with Ulcerative Colitis (UC) and Crohn Disease (CD), run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum 25-hydroxyvitamin D levels between baseline and week 8 (time frame: Baseline and week 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.