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

Primary Purpose

Nutrition Disorders in Old Age, Disaster

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Clinical study on the mangrove sword bean food bar effect for older people
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nutrition Disorders in Old Age focused on measuring Older people, disaster, weight, mangrove-sword bean food bar

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Health integrated post for older people office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Control Group

Arm 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 per day during 15 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2023
Last Updated
June 12, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05897892
Brief Title
The Clinical Study on the Mangrove Sword Bean Food Bar Effect for Older People
Acronym
FF
Official Title
School of Environmental Sciences - University of Indonesia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders in Old Age, Disaster
Keywords
Older people, disaster, weight, mangrove-sword bean food bar

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Treatment group consumed mangrove sword bean food bar during 15 days. Control group consumed sword bean food bar during 15 days.
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Treatment group received 50 g mangrove sword bean food bar each day during 15 days.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Control group received 50 g sword bean food bar per day during 15 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Clinical study on the mangrove sword bean food bar effect for older people
Other Intervention Name(s)
EFP
Intervention Description
The treatment group consumed 50 g mangrove sword bean food bar each day during 15 days.
Primary Outcome Measure Information:
Title
Mangrove sword bean food bar on the weight of older people
Description
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.
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Balanced nutrition knowledge of older people
Description
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
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatmah Fatmah, Dr.
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health integrated post for older people office
City
Sumedang
State/Province
West Java
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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