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

NCT ID: NCT02554318

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-02-28

Brief 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.

Conditions

Pulmonary Tuberculosis; Body Weight Changes; Motor Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Rifampicin

Intervention Type: DRUG

Isoniazid

Intervention Type: DRUG

Pyrazinamide

Intervention Type: DRUG

Ethambutol

Intervention Type: DRUG

Fermented soybean

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: ACTIVE_COMPARATOR

Rifampicin

Intervention Type: DRUG

Isoniazid

Intervention Type: DRUG

Pyrazinamide

Intervention Type: DRUG

Ethambutol

Intervention Type: DRUG

Interventions

Rifampicin

Intervention Type: DRUG

Isoniazid

Intervention Type: DRUG

Pyrazinamide

Intervention Type: DRUG

Ethambutol

Intervention Type: DRUG

Fermented soybean

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Rifampin; Rifadin; Hydra; Isovit; Actizid; Cavizide; Myambutol; Servambutol; Tempeh

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesian Directorate General of Higher Education

OTHER_GOV

Sponsor Role: collaborator

University of Giessen

OTHER

Sponsor Role: lead

Responsible Party

Budhi Setiawan

dr, M.Kes

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael B Krawinkel, Prof. Dr.

Role: STUDY_DIRECTOR

University of Giessen

References

Paton NI, Chua YK, Earnest A, Chee CB. Randomized controlled trial of nutritional supplementation in patients with newly diagnosed tuberculosis and wasting. Am J Clin Nutr. 2004 Aug;80(2):460-5. doi: 10.1093/ajcn/80.2.460.

Reference Type: BACKGROUND

PMID: 15277171 (View on PubMed)

Martins N, Morris P, Kelly PM. Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste. BMJ. 2009 Oct 26;339:b4248. doi: 10.1136/bmj.b4248.

Reference Type: BACKGROUND

PMID: 19858174 (View on PubMed)

Jahnavi G, Sudha CH. Randomised controlled trial of food supplements in patients with newly diagnosed tuberculosis and wasting. Singapore Med J. 2010 Dec;51(12):957-62.

Reference Type: BACKGROUND

PMID: 21221502 (View on PubMed)

PrayGod G, Range N, Faurholt-Jepsen D, Jeremiah K, Faurholt-Jepsen M, Aabye MG, Jensen L, Jensen AV, Grewal HM, Magnussen P, Changalucha J, Andersen AB, Friis H. The effect of energy-protein supplementation on weight, body composition and handgrip strength among pulmonary tuberculosis HIV-co-infected patients: randomised controlled trial in Mwanza, Tanzania. Br J Nutr. 2012 Jan;107(2):263-71. doi: 10.1017/S0007114511002832. Epub 2011 Jul 6.

Reference Type: BACKGROUND

PMID: 21729372 (View on PubMed)

Other Identifiers

DGHE 626/E4.4/K/2011

Identifier Type: -

Identifier Source: org_study_id