Safety IssuesNCT04499482
Safety and Tolerability of Soy Fiber
A study testing Food in people with Safety Issues and Tolerance, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This is a dose escalation trial in the elderly with obesity to determine the maximum tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods. Read more about this study
- Who is it for?
- Ages 70 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Tolerance
- What is being tested?
- Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 14 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adult (70 - 85 years).
- Body mass index between 30 and 40 kg/m2.
- No evidence of diabetes (fasting blood sugar <126 mg/dL).
- No evidence of dementia (MMSE score > 25).
- No evidence of depression. (Geriatric Depression Scale-15 [GDS-15] < 6.
- Are weight stable (< 3 kg weight change in the past three months).
Who cannot join
- Have type 1 or type 2 diabetes currently being treated by medication.
- Report clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, or celiac disease.
- Are being treated with medications that have a significant effect on insulin resistance, obesity, and metabolic rate, or medications that significantly increase body weight such as antidepressants, second-generation antipsychotics, systemic glucocorticoids, and adrenergic blockers or stimulators (unless the dose and body weight have been stable for six months).
- Have serum triglyceride concentrations > 400 mg/dl.
- Clinically significant abnormal laboratory markers (as determined by the medical investigator).
- Subjects with anticipated surgery during the study period.
Show all 10Show fewer
- Subjects with a reported history of substance abuse or alcoholism or significant psychiatric disorder that would interfere with the ability to complete the study.
- Subjects who are current smokers or have smoked within the previous three months. Smoking is not permitted during the study.
- Subjects who are unable to provide a baseline blood or fecal sample or if they have any condition that impedes testing of the study hypothesis or makes it unsafe to consume the food being tested in the study (determined by the investigative team).
- Women on hormone replacement therapy unless weight has been stable over the last six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Safety and Tolerability of Soy Fiber in the Elderly: A Dose Escalation Study
This is a dose escalation trial in the elderly with obesity to determine the maximum tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.
Read the detailed description
The tolerability to 10 g, 20 g, and 30 g of soy will be tested. At each dose, eight subjects will incorporate the foods containing soy into their usual diet for one week. The tolerability to each dose will be evaluated and fecal short chain fatty acids will be measured as a biomarker of compliance. Subjects who satisfy the eligibility criteria and express willingness to consume the study foods will be enrolled.
- Conditions
- Safety Issues, Tolerance
- Being tested
- Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodOther
Soy-fiber containing food
| Study group | Role | What they receive |
|---|---|---|
| Foods containing 10 g soy flour | Experimental | Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period. Receives: Other: Food |
| Foods containing 20 g soy flour | Experimental | Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period. Receives: Other: Food |
| Foods containing 30 g soy flour | Experimental | Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week. Receives: Other: Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy
Dose safety will be investigated by compiling by treatment (e.g. 10 g dose, 20 g dose, 30 g dose) a list of adverse events such as frequency of headaches, nausea, vomiting. The study physician in consultation with the coordinator will review and determine safety
Measured: One week at each dose
10 g Soy-related Gastrointestinal Symptoms
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
Measured: One week
20 g Soy-related Gastrointestinal Symptoms
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
Measured: One week
30 g Soy-related Gastrointestinal Symptoms
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
Measured: One week
10 g Soy-related Stool Frequency
Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
Measured: One week
20 g Soy-related Stool Frequency
Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
Measured: One week
30 g Soy-related Stool Frequency
Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
Measured: One week
10 Soy-related Stool Consistency
Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
Measured: One week
20 g Soy-related Stool Consistency
Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
Measured: One week
30 g Soy-related Stool Consistency
Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
Measured: One week
Secondary outcomes (3)
10 g Soy Intake Effect on Fecal Short Chain Fatty Acids
Measurement of fecal short chain fatty acids in response to intake of soy
Measured: One week
20 g Soy Intake Effect on Fecal Short Chain Fatty Acids
Measurement of fecal short chain fatty acids in response to intake of soy
Measured: One week
30 g Soy Intake Effect on Fecal Short Chain Fatty Acids
Measurement of fecal short chain fatty acids in response to intake of soy
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start4 Oct 2021
- Primary completion14 Apr 2022
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Dose escalating cross over trial
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Candida Rebello, Pennington Biomedical Research Center
- Investigators
- Candida Rebello, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499482
- Sponsor's protocol ID
- PBRC 2020-010
- Other IDs
- 1K99AG065419-01A1
- Status last verified
- May 2023
- First submitted
- 31 Jul 2020
- Last updated
- 18 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Soy Fiber in the Elderly: A Dose Escalation Study
- ClinicalTrials.gov ID
- NCT04499482
- Acronym / sponsor ID
- PBRC 2020-010
- Conditions
- Safety Issues, Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Posted 18 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a dose escalation trial in the elderly with obesity to determine the maximum tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.
Detailed description
The tolerability to 10 g, 20 g, and 30 g of soy will be tested. At each dose, eight subjects will incorporate the foods containing soy into their usual diet for one week. The tolerability to each dose will be evaluated and fecal short chain fatty acids will be measured as a biomarker of compliance. Subjects who satisfy the eligibility criteria and express willingness to consume the study foods will be enrolled.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose escalating cross over trial
| Arm | Type | Receives |
|---|---|---|
| Foods containing 10 g soy flour | Experimental | Other: FoodParticipants will receive foods containing 10 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period. |
| Foods containing 20 g soy flour | Experimental | Other: FoodParticipants will receive foods containing 20 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period. |
| Foods containing 30 g soy flour | Experimental | Other: FoodParticipants will receive foods containing 30 g of soy flour to be consumed everyday for one week. |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Adult (70 - 85 years).
- Body mass index between 30 and 40 kg/m2.
- No evidence of diabetes (fasting blood sugar <126 mg/dL).
- No evidence of dementia (MMSE score > 25).
- No evidence of depression. (Geriatric Depression Scale-15 [GDS-15] < 6.
Key exclusion criteria (10 listed)
- Have type 1 or type 2 diabetes currently being treated by medication.
- Report clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, or celiac disease.
- Are being treated with medications that have a significant effect on insulin resistance, obesity, and metabolic rate, or medications that significantly increase body weight such as antidepressants, second-generation antipsychotics, systemic glucocorticoids, and adrenergic blockers or stimulators (unless the dose and body weight have been stable for six months).
- Have serum triglyceride concentrations > 400 mg/dl.
- Clinically significant abnormal laboratory markers (as determined by the medical investigator).
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 |
|---|---|---|
| FoodSoy-fiber containing food | Other | Foods containing 10 g soy flour, Foods containing 20 g soy flour, Foods containing 30 g soy flour |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy
Time frame: One week at each dose
Dose safety will be investigated by compiling by treatment (e.g. 10 g dose, 20 g dose, 30 g dose) a list of adverse events such as frequency of headaches, nausea, vomiting. The study physician in consultation with the coordinator will review and determine safety
10 g Soy-related Gastrointestinal Symptoms
Time frame: One week
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
20 g Soy-related Gastrointestinal Symptoms
Time frame: One week
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
30 g Soy-related Gastrointestinal Symptoms
Time frame: One week
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
10 g Soy-related Stool Frequency
Time frame: One week
Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
20 g Soy-related Stool Frequency
Time frame: One week
Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
30 g Soy-related Stool Frequency
Time frame: One week
Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
10 Soy-related Stool Consistency
Time frame: One week
Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
20 g Soy-related Stool Consistency
Time frame: One week
Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
30 g Soy-related Stool Consistency
Time frame: One week
Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
3 secondary outcomes
10 g Soy Intake Effect on Fecal Short Chain Fatty Acids
Time frame: One week
20 g Soy Intake Effect on Fecal Short Chain Fatty Acids
Time frame: One week
30 g Soy Intake Effect on Fecal Short Chain Fatty Acids
Time frame: One week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Candida Rebello, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food in people with Safety Issues and Tolerance, run by Pennington Biomedical Research Center at 1 site in United States.
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 10 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 18 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy (time frame: One week at each dose). The study lists 10 primary outcomes in all. 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 18 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.