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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

Other trials in United States

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 groups in NCT04499482
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.

4 Oct 202114 Apr 2022

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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

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

Results posted to the registry on 18 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Foods Containing 10 g Soy Flour	8	7

Primary outcome: Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy

Time frame: One week at each dose. Count of participants. Unit: Participants

Measure	Foods Containing 10 g Soy Flour n = 7	Foods Containing 20 g Soy Flour n = 7	Foods Containing 30 g Soy Flour n = 7
Value	0	1	1

Population analysed: One subject dropped from the study at Day 3 of week one and was not included in the analysis.

Primary outcome: 10 g Soy-related Gastrointestinal Symptoms

Time frame: One week. Count of participants. Unit: Participants

Measure	Foods Containing 10 g Soy Flour n = 7
Bloating: Mild	1
Bloating: None	6
Abdominal Rumbling: Mild	2
Abdominal Rumbling: None	5
Flatulence: Mild	2
Flatulence: None	5
Abdominal Pain: Mild	0
Abdominal Pain: None	7

Population analysed: One subject dropped from the study at Day 3 of week one and was excluded from the analysis.

Primary outcome: 20 g Soy-related Gastrointestinal Symptoms

Time frame: One week. Count of participants. Unit: Participants

Measure	Foods Containing 20 g Soy Flour n = 7
Bloating: Mild	0
Bloating: None	7
Abdominal Rumbling: Mild	1
Abdominal Rumbling: None	6
Flatulence: Mild	5
Flatulence: None	2
Abdominal pain: Mild	0
Abdominal pain: None	7

Population analysed: One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.

Primary outcome: 30 g Soy-related Gastrointestinal Symptoms

Time frame: One week. Count of participants. Unit: Participants

Measure	Foods Containing 30 g Soy Flour n = 7
Bloating: Mild	1
Bloating: None	6
Abdominal Rumbling: Mild	1
Abdominal Rumbling: None	6
Flatulence: Mild	5
Flatulence: None	2
Abdominal Pain: Mild	1
Abdominal Pain: None	6

Population analysed: One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: One week at each dose. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Foods Containing 10g Soy Flour	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Foods Containing 20g Soy Flour	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
Foods Containing 30g Soy Flour	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7

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?

On the ClinicalTrials.gov record for NCT04499482.

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.