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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05897892
Other study ID # SILUI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date August 20, 2022

Study information

Verified date June 2023
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date August 20, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Dietary Supplement:
Clinical study on the mangrove sword bean food bar effect for older people
The treatment group consumed 50 g mangrove sword bean food bar each day during 15 days.

Locations

Country Name City State
Indonesia Health integrated post for older people office Sumedang West Java

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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