NCT05897892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

14 days

First QC Date

May 23, 2023

Last Update Submit

June 12, 2023

Conditions

Nutrition Disorders in Old AgeDisaster

Keywords

Older peopledisasterweightmangrove-sword bean food bar

Outcome Measures

Primary Outcomes (1)

  • 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.

    Two weeks

Secondary Outcomes (1)

  • Balanced nutrition knowledge of older people

    Two weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

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

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

Also known as: EFP
Control GroupTreatment Group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Having difficulty mobilities to run daily basic activities.
  • Suffered from infectious and or a chronical diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health integrated post for older people office

Sumedang, West Java, Indonesia

Location

Related Publications (1)

  • Fatmah F. Effectiveness of mangrove sword bean food bar addressed to older people of landslide disaster victims. Front Nutr. 2024 Apr 8;11:1291580. doi: 10.3389/fnut.2024.1291580. eCollection 2024.

    PMID: 38650640DERIVED

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fatmah Fatmah, Dr.

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Treatment group consumed mangrove sword bean food bar during 15 days. Control group consumed sword bean food bar during 15 days.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 9, 2023

Study Start

August 1, 2022

Primary Completion

August 15, 2022

Study Completion

August 20, 2022

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)