HealthyNCT03385590
Feasibility and Acceptability of a Soy-fiber-maize Complementary Food in Malawi.
A study testing Soy-fiber-maize and Maize in people with Healthy, run by University of Florida at 1 site in Malawi.
Trial summary
The purpose of this intervention study is to assess the feasibility and acceptability of soy-fiber-maize versus soy-maize complementary foods on bowel movement frequency, transit time, growth, gastrointestinal symptoms, microbiota composition and activity. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Soy-fiber-maize and Maize
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteMalawi
- Study dates
- 21 Jun 2018to 30 Nov 2019
- 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 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Willing to have height and weight measured and provide demographic information (e.g age, race, sex).
- Willing to consume soy fiber or control porridge twice daily for a 6 months' period
- Willing to complete a weekly questionnaire throughout the entire 6 months' study.
- Willing to be interviewed for 24-Hour recall 3 times per 6 months' period throughout the study.
- Willing to provide 3 stool samples, one in each 2-weeks period throughout the study.
Who cannot join
- Have any known food allergies.
- Are currently taking medications for diarrhea.
- Have taken antibiotics within the past four weeks prior to randomization.
- Have more than 3 diarrheal episodes in the last week
- Currently participating in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility and Acceptability of a Soy-fiber-maize Blend Complementary Food and Its Effects on Stool Frequency, Stool Consistency, Microbiota Composition, Growth, and Dietary Intake of Children Aged 6 to 36 Months in Malawi.
The purpose of this intervention study is to assess the feasibility and acceptability of soy-fiber-maize versus soy-maize complementary foods on bowel movement frequency, transit time, growth, gastrointestinal symptoms, microbiota composition and activity.
Read the detailed description
This is a 6-month randomized study to assess the feasibility and acceptability of soy-fiber-maize complementary food. Participants (caregiver/mother - child pairs) will complete a 2-week baseline period during which stool frequency, and stool consistency will be collected by paper questionnaire, and participants will collect a single stool. Dietary data will be obtained at baseline, 3 months and at 6 months during the study period. Participants will receive soy-fiber-maize or maize complementary foods twice a day for 6 months. Participants will attend a study visit every week for study food collection. During the study visit at baseline, 3 and 6 months, participants will complete a 24-hour dietary recall and height, weight and Mid Upper Arm Circumference will be measured on the children. At these same times, participants will provide stool samples. Participants will complete weekly questionnaires to assess gastrointestinal health, stool frequency and stool form. Furthermore, participants will participate in a focus group discussion at the end of the 6 months' study period to assess the feasibility and acceptability of soy-fiber-maize complementary foods for their children. Stool samples will be analyzed for differences in the microbiota.
- Conditions
- Healthy
- Being tested
- Soy-fiber-maize, Maize
- Keywords
- healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy-fiber-maizeDietary supplement
Two servings of soy-maize porridge fortified with soy fiber (1.3 g per serving) will be consumed by the children each day for a period of six months.
MaizeDietary supplement
Two servings of maize porridge will be consumed by the children each day for a period of six months.
| Study group | Role | What they receive |
|---|---|---|
| Soy-fiber-maize | Experimental | Complementary food composed of soybean, soy fiber and maize flours. Receives: Dietary Supplement: Soy-fiber-maize |
| Maize | Active comparator | Complementary food composed of maize flour. Receives: Dietary Supplement: Maize |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to feeding protocol
Acceptability and feasibility of soy-fiber-maize blend versus maize only complementary food as measured by compliance to feeding complementary food.
Measured: Weekly - baseline through 6 months
Secondary outcomes (5)
Stool consistency
Stool consistency rating by Modified Bristol Stool Form Scale for Children, scale of 1-5, = with fewer 4 and 5 scores considered improvment.
Measured: Weekly - baseline through 6 months
Number of bowel movements
Number of bowel movements per week
Measured: Weekly - baseline through 6 months
Microbiota profile changes
Percent change at phylum and genus levels; changes in OTUs
Measured: Baseline, month 3 and month 6
Growth
Increase in height, weight and Mid Upper Arm Circumference
Measured: Baseline, month 3 and month 6
Dietary intake
24-hour dietary recall assessing intake of children
Measured: Baseline, month 3 and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start21 Jun 2018
- Primary completion31 Dec 2018
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children 6-36 months will be fed soy-fiber-maize or soy-maize complementary foods for 6 months.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University
- Responsible party
- Sponsor
- Investigators
- Wendy Dahl, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385590
- Sponsor's protocol ID
- IRB201700644
- Status last verified
- Dec 2019
- First submitted
- 20 Dec 2017
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Acceptability of a Soy-fiber-maize Blend Complementary Food and Its Effects on Stool Frequency, Stool Consistency, Microbiota Composition, Growth, and Dietary Intake of Children Aged 6 to 36 Months in Malawi.
- ClinicalTrials.gov ID
- NCT03385590
- Acronym / sponsor ID
- IRB201700644
- Conditions
- Healthy
- Keywords
- healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Michigan State University
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 28 Dec 2017 (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 purpose of this intervention study is to assess the feasibility and acceptability of soy-fiber-maize versus soy-maize complementary foods on bowel movement frequency, transit time, growth, gastrointestinal symptoms, microbiota composition and activity.
Detailed description
This is a 6-month randomized study to assess the feasibility and acceptability of soy-fiber-maize complementary food. Participants (caregiver/mother - child pairs) will complete a 2-week baseline period during which stool frequency, and stool consistency will be collected by paper questionnaire, and participants will collect a single stool. Dietary data will be obtained at baseline, 3 months and at 6 months during the study period. Participants will receive soy-fiber-maize or maize complementary foods twice a day for 6 months. Participants will attend a study visit every week for study food collection. During the study visit at baseline, 3 and 6 months, participants will complete a 24-hour dietary recall and height, weight and Mid Upper Arm Circumference will be measured on the children. At these same times, participants will provide stool samples. Participants will complete weekly questionnaires to assess gastrointestinal health, stool frequency and stool form. Furthermore, participants will participate in a focus group discussion at the end of the 6 months' study period to assess the feasibility and acceptability of soy-fiber-maize complementary foods for their children. Stool samples will be analyzed for differences in the microbiota.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Children 6-36 months will be fed soy-fiber-maize or soy-maize complementary foods for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Soy-fiber-maize | Experimental | Dietary Supplement: Soy-fiber-maizeComplementary food composed of soybean, soy fiber and maize flours. |
| Maize | Active comparator | Dietary Supplement: MaizeComplementary food composed of maize flour. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Willing to have height and weight measured and provide demographic information (e.g age, race, sex).
- Willing to consume soy fiber or control porridge twice daily for a 6 months' period
- Willing to complete a weekly questionnaire throughout the entire 6 months' study.
- Willing to be interviewed for 24-Hour recall 3 times per 6 months' period throughout the study.
- Willing to provide 3 stool samples, one in each 2-weeks period throughout the study.
Key exclusion criteria (5 listed)
- Have any known food allergies.
- Are currently taking medications for diarrhea.
- Have taken antibiotics within the past four weeks prior to randomization.
- Have more than 3 diarrheal episodes in the last week
- Currently participating in a clinical trial.
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 |
|---|---|---|
| Soy-fiber-maizeTwo servings of soy-maize porridge fortified with soy fiber (1.3 g per serving) will be consumed by the children each day for a period of six months. | Dietary supplement | Soy-fiber-maize |
| MaizeTwo servings of maize porridge will be consumed by the children each day for a period of six months. | Dietary supplement | Maize |
Primary outcome
Compliance to feeding protocol
Time frame: Weekly - baseline through 6 months
Acceptability and feasibility of soy-fiber-maize blend versus maize only complementary food as measured by compliance to feeding complementary food.
5 secondary outcomes
Stool consistency
Time frame: Weekly - baseline through 6 months
Number of bowel movements
Time frame: Weekly - baseline through 6 months
Microbiota profile changes
Time frame: Baseline, month 3 and month 6
Growth
Time frame: Baseline, month 3 and month 6
Dietary intake
Time frame: Baseline, month 3 and month 6
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 12 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Wendy Dahl, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy-fiber-maize and Maize in people with Healthy, run by University of Florida at 1 site in Malawi.
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 5 inclusion and 5 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 12 Dec 2019. 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 Malawi. 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. 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?
Compliance to feeding protocol (time frame: Weekly - baseline through 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2019.