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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-18

No results posted yet for this study

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)

Interventions

OTHER

Standard medical treatment

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

DIETARY_SUPPLEMENT

Tempeh Isoflavone

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.

DIETARY_SUPPLEMENT

Vitamin D (Cholecalciferol )

Participants receive oral supplementation of vitamin D3 4000 IU/day , administered orally for 8 weeks in addition to standard medical therapy.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2026-01-19
Completion
2026-02-25

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07656233 on ClinicalTrials.gov