Clinical trial NCT02554318: Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia
Official title: The Effect of Fermented Soybean Supplementation on the Body Weight and Physical Function of Tuberculosis Patients With Standard Therapy in Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Tuberculosis
Body Weight Changes
Motor Activity
Keywords: Tempeh
Body weight
Handgrip strength
6MWT
Supplementation
Wasting
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Indonesian Directorate General of Higher Education
First posted: 2015-09-18
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months
timeFrame: Baseline, 2 months
Secondary outcomes:
measure: Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months
timeFrame: Baseline, 2 months
measure: Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months
timeFrame: Baseline, 2 months
measure: Change in Body Mass Index (BMI) From Baseline at 2 Months
timeFrame: Baseline, 2 months
Other outcomes:
measure: Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th.
timeFrame: In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.
measure: Protein Intake on 24-hour Dietary Recall Method.
timeFrame: In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.
Locations:
Study officials:
affiliation: University of Giessen
name: Michael B Krawinkel, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.