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

University of Giessen

Status: Completed

Conditions: Pulmonary Tuberculosis; Motor Activity; Body Weight Changes

Treatments: Dietary Supplement: Fermented soybean; Drug: Ethambutol; Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02554318

DGHE 626/E4.4/K/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Drug: Pyrazinamide

Drug: Isoniazid

Drug: Rifampicin

Drug: Ethambutol

Dietary Supplement: Fermented soybean

Control

Active Comparator group

Description:

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

Treatment:

Drug: Pyrazinamide

Drug: Isoniazid

Drug: Rifampicin

Drug: Ethambutol