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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT05897892
Collaborator
(none)
31
Enrollment
1
Location
2
Arms
19
Actual Duration (Days)
49.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Clinical study on the mangrove sword bean food bar effect for older people
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant)
Masking Description:
Treatment group consumed mangrove sword bean food bar during 15 days. Control group consumed sword bean food bar during 15 days.
Primary Purpose:
Prevention
Official Title:
School of Environmental Sciences - University of Indonesia
Actual Study Start Date :
Aug 1, 2022
Actual Primary Completion Date :
Aug 15, 2022
Actual Study Completion Date :
Aug 20, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Health integrated post for older people office Sumedang West Java Indonesia

    Sponsors and Collaborators

    • Indonesia University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fatmah Fatmah, Principal Investigator, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT05897892
    Other Study ID Numbers:
    • SILUI
    First Posted:
    Jun 9, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fatmah Fatmah, Principal Investigator, Indonesia University
    Older people
    disaster
    weight
    mangrove-sword bean food bar
    Additional relevant MeSH terms:
    Nutrition Disorders

    Study Results

    No Results Posted as of Jun 15, 2023