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

Not Applicable

Completed

• Conditions: Nutrition Disorders in Old Age; Disaster
• Interventions: Dietary Supplement: Clinical study on the mangrove sword bean food bar effect for older people

• Registration Number: NCT05897892
• Lead Sponsor: Indonesia University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-20
• Study First Submitted: 2023-05-23
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-09
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Clinical study on the mangrove sword bean food bar effect for older people	Treatment group received 50 g mangrove sword bean food bar each day during 15 days.
Control Group	Clinical study on the mangrove sword bean food bar effect for older people	Control group received 50 g sword bean food bar per day during 15 days.

Primary Outcome Measures

Name	Time	Method
Mangrove sword bean food bar on the weight of older people	Two weeks	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.

Secondary Outcome Measures

Name	Time	Method
Balanced nutrition knowledge of older people	Two weeks	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

Trial Locations

Locations (1)

Health integrated post for older people office; 🇮🇩 Sumedang, West Java, Indonesia