The Clinical Study on the Mangrove Sword Bean Food Bar Effect for Older People

Study Overview
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Brief Summary
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The goal of this clinical study is to assess the api-api mangrove sword bean food bar effect on the older people's weight affected by a landslide The main questions aimed to answer are: Can api-api mangrove sword bean food bar improve the weight of older people affected by landslide? Can balanced nutrition education increase the older peoples' knowledge? Participants divided in the two groups i.e.: Treatment group received 50 g mangrove sword bean food bar each day during 15 days. Control group received 50 g sword bean food bar each day during 15 days. Both groups obtained balanced nutrition of older people education once at the first week of study.

Detailed Description
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Treatment group received 50 g mangrove sword bean food bar each day during 15 days. Control group received 50 g sword bean food bar each day during 15 days. Both groups obtained balanced nutrition of older people education once at the first week of study. Compliance monitoring to control the food compliance by the subjects at two groups through home visit, weight measurement, three days food recall, and food bar distribution checking by trained enumerators.

Official Title
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School of Environmental Sciences - University of Indonesia

Conditions
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Nutrition Disorders in Old Age, Disaster

Intervention / Treatment
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* Dietary Supplement: Clinical study on the mangrove sword bean food bar effect for older people


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 60 years old or above Male and female Living in Cihanjuang Village, Sumedang District, West Java Province Indonesia who affected by the landslide disaster Had normal, under-, or over-nutrition status Not suffering from chronic diseases or degenerative diseases during the study. Willing to avoid consumption of any snacks other than the food bars and plain water. Exclusion Criteria: Having difficulty mobilities to run daily basic activities. Suffered from infectious and or a chronical diseases.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment group consumed mangrove sword bean food bar during 15 days. Control group consumed sword bean food bar during 15 days. Balanced nutrition education undertaken to all subjects at two groups once at the first week of study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Treatment group received 50 g mangrove sword bean food bar each day during 15 days. | Dietary Supplement: Clinical study on the mangrove sword bean food bar effect for older people<br>* The treatment group consumed 50 g mangrove sword bean food bar each day during 15 days.<br>* Other names: EFP;|
| Placebo Comparator: Control Group<br>Control group received 50 g sword bean food bar per day during 15 days. | Dietary Supplement: Clinical study on the mangrove sword bean food bar effect for older people<br>* The treatment group consumed 50 g mangrove sword bean food bar each day during 15 days.<br>* Other names: EFP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mangrove sword bean food bar on the weight of older people | 50 g mangrove sword bean food bar each day given to treatment group. 50 g sword bean food bar each day consumed by the control group. Weight measured by digital weighing SECA by trained enumerator at the first week and the second week of study. | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balanced nutrition knowledge of older people | Both groups received the balance nutrition education once at the second week of study. The knowledge change of older people measured by the baseline and end-line questionnaires by trained enumerators | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older people, disaster, weight, mangrove-sword bean food bar