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Completed

NCT Number: NCT05897892

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

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health integrated post for older people office

Sumedang, West Java, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical study on the mangrove sword bean food bar effect for older people

Dietary Supplement

The treatment group consumed 50 g mangrove sword bean food bar each day during 15 days.

Other names: EFP

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

School of Environmental Sciences - University of Indonesia

Acronym: FF

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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