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

NCT02554318 | Completed Results

• 1 other identifier: DGHE 626/E4.4/K/2011
• Study Type: interventional
• Target: 147
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Tuberculosis; Body Weight Changes; Motor Activity

Keywords

Tempeh; Body weight; Handgrip strength; 6MWT; Supplementation; Wasting

Outcome Measures

Primary Outcomes (1)

• Change in Bodyweight on a Digital Weight Scale From Baseline at 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.

  Baseline, 2 months

Secondary Outcomes (3)

• Change in Hand-grip Strength on a Digital Dynamometer Scale 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 Body Mass Index (BMI) From Baseline at 2 Months

  Baseline, 2 months

Other Outcomes (2)

• Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th.

  In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.

• Protein Intake on 24-hour Dietary Recall Method.

  In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.

Study Arms (2)

Intervention

EXPERIMENTAL

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; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol; Dietary Supplement: Fermented soybean

Control

ACTIVE COMPARATOR

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; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol

Interventions

Rifampicin DRUG

Also known as: Rifampin, Rifadin

Control; Intervention

Isoniazid DRUG

Also known as: Hydra, Isovit

Control; Intervention

Pyrazinamide DRUG

Also known as: Actizid, Cavizide

Control; Intervention

Ethambutol DRUG

Also known as: Myambutol, Servambutol

Control; Intervention

Fermented soybean DIETARY_SUPPLEMENT

Also known as: Tempeh

Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Heavy smoker (\> 20 cigarettes per day)
• Pregnancy and lactation
• Extra pulmonary TB
• Known allergy to soybean
• Having clinical evidences of any underlying disease

Sponsors & Collaborators

• University of Giessen: lead
• Indonesian Directorate General of Higher Education: collaborator

Related Publications (4)

• 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.

  PMID: 15277171 BACKGROUND

• 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.

  PMID: 19858174 BACKGROUND

• 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.

  PMID: 21221502 BACKGROUND

• 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.

  PMID: 21729372 BACKGROUND

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Body Weight Changes; Motor Activity; Body Weight; Cachexia

Interventions

Rifampin; Isoniazid; Pyrazinamide; Ethambutol; Soy Foods

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Weight Loss; Thinness

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring; Pyrazines; Ethylenediamines; Diamines; Polyamines; Amines; Fermented Foods; Diet, Food, and Nutrition; Physiological Phenomena; Vegetable Products; Vegetables; Food; Food and Beverages

Limitations and Caveats

It needs more participants and not all patients were tested for HIV since it was not suitable for the local culture. High temperature which is involved in the cooking process could change the chemical properties of tempeh. Since physical activity consists of complex aspects, a combination of several tools can be used in a study to give a comprehensive view of interpretation.

Results Point of Contact

• Title: Dr. Budhi Setiawan
• Organization: Medical Faculty Wijaya Kusuma Surabaya

nehesa@gmail.com

+6287751644522

Study Officials

• Michael B Krawinkel, Prof. Dr.

  University of Giessen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr, M.Kes

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 18, 2015
• Study Start: November 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 21, 2022
• Results First Posted: June 21, 2022

Record last verified: 2022-05