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

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ClinicalTrials.gov Identifier: NCT02554318
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : September 18, 2015
Sponsor:
Collaborator:
Indonesian Directorate General of Higher Education
Information provided by (Responsible Party):
Budhi Setiawan, University of Giessen

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.

Condition or disease Intervention/treatment Phase
Pulmonary Tuberculosis Body Weight Changes Motor Activity Drug: Rifampicin Drug: Isoniazid Drug: Pyrazinamide Drug: Ethambutol Dietary Supplement: Fermented soybean Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Fermented Soybean Supplementation on the Body Weight and Physical Function of Tuberculosis Patients With Standard Therapy in Indonesia
Study Start Date : October 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

Drug: Rifampicin
Other Names:
  • Rifampin
  • Rifadin

Drug: Isoniazid
Other Names:
  • Hydra
  • Isovit

Drug: Pyrazinamide
Other Names:
  • Actizid
  • Cavizide

Drug: Ethambutol
Other Names:
  • Myambutol
  • Servambutol

Dietary Supplement: Fermented soybean
Other Name: Tempeh

Active Comparator: 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

Drug: Rifampicin
Other Names:
  • Rifampin
  • Rifadin

Drug: Isoniazid
Other Names:
  • Hydra
  • Isovit

Drug: Pyrazinamide
Other Names:
  • Actizid
  • Cavizide

Drug: Ethambutol
Other Names:
  • Myambutol
  • Servambutol




Primary Outcome Measures :
  1. Body weight on a digital weight scale [ Time Frame: Baseline, 2 months ]
    The change of body weight to the participants over the two months intervention period as measured in kilograms scale.


Secondary Outcome Measures :
  1. Hand-grip strength on a baseline digital dynamometer scale [ Time Frame: Baseline, 2 months ]
    The change of hand-grip strength to the participants over the two months intervention period as measured in kilograms scale.

  2. The distance on 6-minute walk test (6MWT) [ Time Frame: Baseline, 2 months ]
    The change distance in meters scale as assessed by 6MWT according to American Thoracic Society (ATS) 2002 guidelines over the two months intervention period.

  3. Body mass index (BMI) [ Time Frame: Baseline, 2 months ]
    The change of BMI to the participants as assessed by a digital weight scale and height scale (kg/m2) over the two months intervention period.


Other Outcome Measures:
  1. Caloric intake on 24-hour dietary recall method. [ Time Frame: In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week. ]
    The average of calorie intake (in kcal/day) was assessed by the 24-hour dietary recall questionnaire and calculated by NutriSurvey software version 2005, with the country specific food database for Indonesia.

  2. Protein intake on 24-hour dietary recall method. [ Time Frame: In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week. ]
    The average of protein intake (in gram/day) was assessed by the 24-hour dietary recall questionnaire and calculated using NutriSurvey software version 2005, with the country specific food database for Indonesia.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554318


Sponsors and Collaborators
University of Giessen
Indonesian Directorate General of Higher Education
Investigators
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Study Director: Michael B Krawinkel, Prof. Dr. University of Giessen

Publications:
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Responsible Party: Budhi Setiawan, dr, M.Kes, University of Giessen
ClinicalTrials.gov Identifier: NCT02554318     History of Changes
Other Study ID Numbers: DGHE 626/E4.4/K/2011
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015

Keywords provided by Budhi Setiawan, University of Giessen:
Tempeh
Body weight
Handgrip strength
6MWT
Supplementation
Wasting

Additional relevant MeSH terms:
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Tuberculosis
Body Weight
Tuberculosis, Pulmonary
Body Weight Changes
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Rifampin
Isoniazid
Pyrazinamide
Ethambutol
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers