Body Weight Changes, Motor Activity, Pulmonary Tuberculosis
Conditions
Keywords
Tempeh, Body weight, Handgrip strength, 6MWT, Supplementation, Wasting
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.
Interventions
Sponsors
Indonesian Directorate General of Higher Education
University of Giessen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months | Baseline, 2 months | The change of hand-grip strength of the participants over the two months intervention period was 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. The higher scores reflected the better physical function outcomes of the patients. |
| Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months | Baseline, 2 months | The change distance in meters scale as assessed by 6MWT according to American Thoracic Society (ATS) 2002 guidelines. The 6MWT was carried out on a track along the 30-meter corridor marked by two colored cones placed at both ends of the track alignment. The participants were asked using the standard instruction to walk at their self-selected pace back and forth between the cones as far as they could for 6 minutes. The distance taken by each participant was measured and then recorded. Instructions were given to every patient by reading a guideline with the same intonations to every patient before performing the test. The result of the 6MWT was expressed in meters. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected better physical function outcomes. |
| Change in Body Mass Index (BMI) From Baseline at 2 Months | Baseline, 2 months | The change in BMI was assessed by a digital weight scale and height scale (kg/m²). The formula for BMI is weight in kilograms divided by height in meters squared. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected the better nutritional status results of the patients. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | The average 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. |
| 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. | The average 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. |
Participant flow
Recruitment details
Between November 2013 and February 2015, patients who attended the lung clinics in Surabaya for newly diagnosed pulmonary TB were screened for study enrollment.
Pre-assignment details
After the enrollment of the study, several participants withdrew their assignment due to several reasons such as underlying disease, heavy smoker, they did not stay in the city, plan to move to other city, and dislike the food.
Participants by arm
| Arm | Count |
|---|---|
| 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
Rifampicin
Isoniazid
Pyrazinamide
Ethambutol
Fermented soybean | 65 |
| 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
Rifampicin
Isoniazid
Pyrazinamide
Ethambutol | 64 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 10 | 8 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 64 Participants | 129 Participants |
| Age, Continuous | 31.11 years STANDARD_DEVIATION 9.63 | 34.45 years STANDARD_DEVIATION 10.35 | 32.77 years STANDARD_DEVIATION 10.09 |
| Body Mass Index | 18.41 Kg/m² STANDARD_DEVIATION 3.1 | 18.57 Kg/m² STANDARD_DEVIATION 3.26 | 18.49 Kg/m² STANDARD_DEVIATION 3.17 |
| Education Bachelor | 4 Participants | 5 Participants | 9 Participants |
| Education Elementary School | 26 Participants | 27 Participants | 53 Participants |
| Education High school | 23 Participants | 24 Participants | 47 Participants |
| Education Middle School | 12 Participants | 8 Participants | 20 Participants |
| Income (million rupiahs) Between one to three | 26 Participants | 27 Participants | 53 Participants |
| Income (million rupiahs) Less than one | 38 Participants | 37 Participants | 75 Participants |
| Income (million rupiahs) More than three | 1 Participants | 0 Participants | 1 Participants |
| Occupation Part timer | 5 Participants | 3 Participants | 8 Participants |
| Occupation Private | 41 Participants | 39 Participants | 80 Participants |
| Occupation Unemployed | 19 Participants | 22 Participants | 41 Participants |
| Race/Ethnicity, Customized Javanese | 32 Participants | 28 Participants | 60 Participants |
| Race/Ethnicity, Customized Madurese | 31 Participants | 34 Participants | 65 Participants |
| Race/Ethnicity, Customized Others | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Indonesia Others | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Indonesia Surabaya, East Java | 65 Participants | 64 Participants | 129 Participants |
| Sex: Female, Male Female | 30 Participants | 29 Participants | 59 Participants |
| Sex: Female, Male Male | 35 Participants | 35 Participants | 70 Participants |
| Sputum Smear Negative | 21 Participants | 20 Participants | 41 Participants |
| Sputum Smear Positive | 44 Participants | 44 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 72 |
| other Total, other adverse events | 1 / 75 | 0 / 72 |
| serious Total, serious adverse events | 0 / 75 | 0 / 72 |
Outcome results
Primary
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.
Time frame: Baseline, 2 months
Population: All participants were assessed their body weight (kg) using an electronic weight scale before and after the study to determine its change.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months | 2.80 Kilogram | Standard Deviation 2.33 |
| Control | Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months | 1.44 Kilogram | Standard Deviation 2.42 |
Secondary
Change in Body Mass Index (BMI) From Baseline at 2 Months
The change in BMI was assessed by a digital weight scale and height scale (kg/m²). The formula for BMI is weight in kilograms divided by height in meters squared. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected the better nutritional status results of the patients.
Time frame: Baseline, 2 months
Population: All participants were assessed before and after the study using a standard formula to determine the change of the body mass index (BMI).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Body Mass Index (BMI) From Baseline at 2 Months | 1.13 Kg/m² | Standard Deviation 0.93 |
| Control | Change in Body Mass Index (BMI) From Baseline at 2 Months | 0.54 Kg/m² | Standard Deviation 0.94 |
Secondary
Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months
The change distance in meters scale as assessed by 6MWT according to American Thoracic Society (ATS) 2002 guidelines. The 6MWT was carried out on a track along the 30-meter corridor marked by two colored cones placed at both ends of the track alignment. The participants were asked using the standard instruction to walk at their self-selected pace back and forth between the cones as far as they could for 6 minutes. The distance taken by each participant was measured and then recorded. Instructions were given to every patient by reading a guideline with the same intonations to every patient before performing the test. The result of the 6MWT was expressed in meters. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected better physical function outcomes.
Time frame: Baseline, 2 months
Population: Not all participants were analyzed before and after the study to measure the change in the distance. Only 64 participants from the intervention group and 63 participants from the control group contributed to data collection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months | 49.67 Meter | Standard Deviation 58.49 |
| Control | Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months | 25.75 Meter | Standard Deviation 56.85 |
Secondary
Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months
The change of hand-grip strength of the participants over the two months intervention period was 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. The higher scores reflected the better physical function outcomes of the patients.
Time frame: Baseline, 2 months
Population: All participants were measured from two-times points, before and after the study in order to analyze their change after 2 months of intervention. Higher values reflected better physical function results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months | 3.90 Kilogram | Standard Deviation 4.5 |
| Control | Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months | 0.84 Kilogram | Standard Deviation 4.83 |
Other Pre-specified
Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th.
The average 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.
Time frame: In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.
Population: Not all participants were assessed their calorie intake, only 61 participants in the control arm and all participants from intervention contributed to the data collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th. | 2nd week | 1980.10 Kcal/day | Standard Deviation 437.79 |
| Intervention | Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th. | 6th week | 2227.98 Kcal/day | Standard Deviation 463.72 |
| Intervention | Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th. | Average | 2113.16 Kcal/day | Standard Deviation 429.41 |
| Control | Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th. | 2nd week | 1844.64 Kcal/day | Standard Deviation 592.13 |
| Control | Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th. | 6th week | 2059.27 Kcal/day | Standard Deviation 550.52 |
| Control | Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th. | Average | 1972.12 Kcal/day | Standard Deviation 530.04 |
Other Pre-specified
Protein Intake on 24-hour Dietary Recall Method.
The average 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.
Time frame: In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.
Population: Not all participants were assessed before and after the study, only 61 participants from the control group contributed to the data collection of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Protein Intake on 24-hour Dietary Recall Method. | 2nd week | 77.34 Gram/day | Standard Deviation 27.98 |
| Intervention | Protein Intake on 24-hour Dietary Recall Method. | 6th week | 77.70 Gram/day | Standard Deviation 26.72 |
| Intervention | Protein Intake on 24-hour Dietary Recall Method. | Average | 77.52 Gram/day | Standard Deviation 26.63 |
| Control | Protein Intake on 24-hour Dietary Recall Method. | 2nd week | 69.49 Gram/day | Standard Deviation 22.81 |
| Control | Protein Intake on 24-hour Dietary Recall Method. | 6th week | 73.35 Gram/day | Standard Deviation 24.37 |
| Control | Protein Intake on 24-hour Dietary Recall Method. | Average | 71.42 Gram/day | Standard Deviation 21.06 |