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

NCT07656233 | Completed

• 1 other identifier: 25-05-0719
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ulcerative Colitis (UC); Crohn Disease (CD)

Keywords

isoflavones; tempeh; vitamin D; inflammatory bowel disease; body composition; TNF-alpha; IL-10

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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).

  Baseline and week 8

Study Arms (2)

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.

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.

Other: Standard medical treatment

Interventions

Standard medical treatment OTHER

Participants do not receive tempeh powder of isoflavone and vitamin D. They receive standard medical therapy of IBD

Standard Therapy; Tempeh Isoflavone and vitamin D

Tempeh Isoflavone DIETARY_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.

Tempeh Isoflavone and vitamin D

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.

Tempeh Isoflavone and vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nutrition Specialist, Lecturer, Department of Clinical Nutrition, Faculty of Medicine, Universitas Indonesia

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 18, 2026
• Study Start: November 17, 2025
• Primary Completion: January 19, 2026
• Study Completion: February 25, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)