The Effect of Fermented Soybean Supplementation on the Body Weight and Physical Function of Tuberculosis Patients With Standard Therapy in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 主要终点
- Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Heavy smoker (> 20 cigarettes per day)
- •Pregnancy and lactation
- •Extra pulmonary TB
- •Known allergy to soybean
- •Having clinical evidences of any underlying disease
研究组 & 干预措施
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
干预措施: Rifampicin (Drug)
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
干预措施: Isoniazid (Drug)
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
干预措施: Pyrazinamide (Drug)
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
干预措施: Ethambutol (Drug)
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
干预措施: Fermented soybean (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
干预措施: Rifampicin (Drug)
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
干预措施: Isoniazid (Drug)
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
干预措施: Pyrazinamide (Drug)
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
干预措施: Ethambutol (Drug)
结局指标
主要结局
Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months
时间窗: 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.
次要结局
- Change in Body Mass Index (BMI) From Baseline at 2 Months(Baseline, 2 months)
- Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months(Baseline, 2 months)
- Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months(Baseline, 2 months)
研究者
Budhi Setiawan
dr, M.Kes
University of Giessen