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

June 12, 2023 updated by: Fatmah Fatmah, Indonesia University

School of Environmental Sciences - University of Indonesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Sumedang, West Java, Indonesia
        • Health integrated post for older people office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
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
The treatment group consumed 50 g mangrove sword bean food bar each day during 15 days.
Other Names:
  • EFP
Placebo Comparator: Control Group
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
The treatment group consumed 50 g mangrove sword bean food bar each day during 15 days.
Other Names:
  • EFP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mangrove sword bean food bar on the weight of older people
Time Frame: 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.
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balanced nutrition knowledge of older people
Time Frame: 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
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Fatmah Fatmah, Dr., Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

August 20, 2022

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SILUI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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