Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia
Condition: Pulmonary Tuberculosis; Body Weight Changes; Motor Activity
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary; Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Rifampicin; Isoniazid; Pyrazinamide; Ethambutol; Fermented soybean
Intervention type(s): Drug; Drug; Drug; Drug; Dietary Supplement
Other intervention name(s): Rifampin; Rifadin; Hydra; Isovit; Actizid; Cavizide; Myambutol; Servambutol; Tempeh
Intervention MeSH terms: Rifampin; Isoniazid; Pyrazinamide; Ethambutol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Tempeh; Body weight; Handgrip strength; 6MWT; Supplementation; Wasting