Nutrition Disorders in Old AgeFFNCT05897892
The Clinical Study on the Mangrove Sword Bean Food Bar Effect for Older People
A study testing Clinical study on the mangrove sword bean food bar effect for older people in people with Nutrition Disorders in Old Age and Disaster, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorders in Old Age, Disaster
- What is being tested?
- Clinical study on the mangrove sword bean food bar effect for older people
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2022to 20 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Having difficulty mobilities to run daily basic activities.
- Suffered from infectious and or a chronical diseases.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Health integrated post for older people office
Sumedang, West Java
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutrition Disorders in Old Age, Disaster
- Being tested
- Clinical study on the mangrove sword bean food bar effect for older people
- Keywords
- Older people, disaster, weight, mangrove-sword bean food bar
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical study on the mangrove sword bean food bar effect for older peopleDietary supplement
Also called EFP
The treatment group consumed 50 g mangrove sword bean food bar each day during 15 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment group received 50 g mangrove sword bean food bar each day during 15 days. Receives: 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. Receives: Dietary Supplement: Clinical study on the mangrove sword bean food bar effect for older people |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Secondary outcomes (1)
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
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Aug 2022
- Primary completion15 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition Disorders in Old AgeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatmah Fatmah, Universitas Indonesia
- Investigators
- Fatmah Fatmah, Dr., Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897892
- Sponsor's protocol ID
- SILUI
- Acronym
- FF
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38650640
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School of Environmental Sciences - University of Indonesia
- ClinicalTrials.gov ID
- NCT05897892
- Acronym / sponsor ID
- FF / SILUI
- Conditions
- Nutrition Disorders in Old Age, Disaster
- Keywords
- Older people, disaster, weight, mangrove-sword bean food bar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: Clinical study on the mangrove sword bean food bar effect for older peopleTreatment group received 50 g mangrove sword bean food bar each day during 15 days. |
| Control Group | Placebo comparator | Dietary Supplement: Clinical study on the mangrove sword bean food bar effect for older peopleControl group received 50 g sword bean food bar per day during 15 days. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Having difficulty mobilities to run daily basic activities.
- Suffered from infectious and or a chronical diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical study on the mangrove sword bean food bar effect for older peopleAlso: EFPThe treatment group consumed 50 g mangrove sword bean food bar each day during 15 days. | Dietary supplement | Control Group, Treatment Group |
Primary outcome
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.
1 secondary outcome
Balanced nutrition knowledge of older people
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 38650640Fatmah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatmah Fatmah, Dr. principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical study on the mangrove sword bean food bar effect for older people in people with Nutrition Disorders in Old Age and Disaster, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mangrove sword bean food bar on the weight of older people (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05897892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.