Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia (FSS)

May 23, 2022 updated by: Budhi Setiawan, University of Giessen

The Effect of Fermented Soybean Supplementation on the Body Weight and Physical Function of Tuberculosis Patients With Standard Therapy in Indonesia

Tuberculosis (TB) patients often have a lower body mass index (BMI) and experience wasting. Wasting reduces lean body mass and may cause physical function impairment. This study aimed to determine the efficacy of fermented soybeans (tempeh) as a food supplement on body weight and physical function changes among active pulmonary tuberculosis patients with standard therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was carried out at the outpatient department building, lung hospital Surabaya, Indonesia. As a national health referral system in TB program, the hospital was related to four local sub district health centers that were involved in the recruitment of participants in the study.

Patients with newly diagnosed pulmonary tuberculosis were randomly assigned into two groups, namely intervention group, which consisted of 65 participants and control group which had 64 participants. Randomization was carried out using sealed, unmarked opaque envelopes that are allocated to participants in this study. A minimum sample size of per group (n=64) was determined by Windows version G*Power 3.1.5 software to identify a mean difference in body weight change of ≥1.1 kg between intervention and control groups.

The intervention group obtained the standard therapy of TB and an additional 166.5 grams of boiled tempeh daily for two months. The control group obtained only standard TB therapy. Patients in the intervention group were instructed to divide one cake tempeh into three pieces and eat them three times in a day. Consumption frequencies of supplements were recorded in a logbook by an enumerator during random visits once a week. One of the patient family members was asked to help to supervise compliance.

The participants were assessed before and after the intervention period for both groups. Body weight of the participants was evaluated by measuring the change in body weight. The change of physical function was assessed by handgrip strength using a digital dynamometer and 6-minute walk test (6MWT). Protein and caloric intakes were estimated twice, measured during the first and second months using 24-hour dietary recall method during the intervention period.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly diagnosed adult male and female TB active patients
  • Having clinical evidences of active TB symptoms
  • Positive or negative sputum smears
  • Having positive chest X-ray that compatible with a diagnosis of tuberculosis
  • No history of previous anti tuberculosis treatment
  • Give a written informed consent and basic contact data

Exclusion Criteria:

  • Heavy smoker (> 20 cigarettes per day)
  • Pregnancy and lactation
  • Extra pulmonary TB
  • Known allergy to soybean
  • Having clinical evidences of any underlying disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

TB standard therapy with fixed dose combination :

once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,

Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets

and 166.5 grams cooked fermented soybean (tempeh) daily for two months
Drug: Rifampicin
Other Names:
  • Rifampin
  • Rifadin
Drug: Pyrazinamide
Other Names:
  • Actizid
  • Cavizide
Drug: Ethambutol
Other Names:
  • Myambutol
  • Servambutol
Drug: Isoniazid
Other Names:
  • Hydra
  • Isovit
Dietary supplement: Fermented soybean
Other Names:
  • Tempeh
Active Comparator: Control

TB standard therapy with fixed dose combination :

once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,

Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets
Drug: Rifampicin
Other Names:
  • Rifampin
  • Rifadin
Drug: Pyrazinamide
Other Names:
  • Actizid
  • Cavizide
Drug: Ethambutol
Other Names:
  • Myambutol
  • Servambutol
Drug: Isoniazid
Other Names:
  • Hydra
  • Isovit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months
Time Frame: Baseline, 2 months
Change of body weight of the participants over the two months intervention period as measured on a kilograms scale. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Positive numbers represent increases and negative numbers represent decreases. A higher value score in change means a better outcome on nutritional status for the patients after the study.
Baseline, 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months
Time Frame: Baseline, 2 months
The change of hand-grip strength of the participants over the two months intervention period was measured on a kilograms scale. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Positive numbers represent increases and negative numbers represent decreases. The higher scores reflected the better physical function outcomes of the patients.
Baseline, 2 months
Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months
Time Frame: Baseline, 2 months
The change distance in meters scale as assessed by 6MWT according to American Thoracic Society (ATS) 2002 guidelines. The 6MWT was carried out on a track along the 30-meter corridor marked by two colored cones placed at both ends of the track alignment. The participants were asked using the standard instruction to walk at their self-selected pace back and forth between the cones as far as they could for 6 minutes. The distance taken by each participant was measured and then recorded. Instructions were given to every patient by reading a guideline with the same intonations to every patient before performing the test. The result of the 6MWT was expressed in meters. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected better physical function outcomes.
Baseline, 2 months
Change in Body Mass Index (BMI) From Baseline at 2 Months
Time Frame: Baseline, 2 months
The change in BMI was assessed by a digital weight scale and height scale (kg/m²). The formula for BMI is weight in kilograms divided by height in meters squared. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected the better nutritional status results of the patients.
Baseline, 2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th.
Time Frame: In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.
The average calorie intake (in kcal/day) was assessed by the 24-hour dietary recall questionnaire and calculated by NutriSurvey software version 2005, with the country-specific food database for Indonesia.
In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.
Protein Intake on 24-hour Dietary Recall Method.
Time Frame: In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.
The average protein intake (in Gram/day) was assessed by the 24-hour dietary recall questionnaire and calculated using NutriSurvey software version 2005, with the country specific food database for Indonesia.
In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Collaborators

Indonesian Directorate General of Higher Education

Investigators

  • Study Director: Michael B Krawinkel, Prof. Dr., University of Gießen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGHE 626/E4.4/K/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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