N/A
Completed N=8
Safety and Tolerability of Soy Fiber
Safety Issues · Tolerance
Source: ClinicalTrials.gov NCT04499482 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy — 0; 1; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy |
0; 1; 1 | — |
| PRIMARY 10 g Soy-related Gastrointestinal Symptoms |
1; 6; 2; 5; 2; 5 | — |
| PRIMARY 20 g Soy-related Gastrointestinal Symptoms |
0; 7; 1; 6; 5; 2 | — |
| PRIMARY 30 g Soy-related Gastrointestinal Symptoms |
1; 6; 1; 6; 5; 2 | — |
| PRIMARY 10 g Soy-related Stool Frequency |
2; 4; 1 | — |
| PRIMARY 20 g Soy-related Stool Frequency |
1; 5; 1 | — |
| PRIMARY 30 g Soy-related Stool Frequency |
1; 3; 3 | — |
| PRIMARY 10 Soy-related Stool Consistency |
2; 3; 2; 0; 0; 0 | — |
| PRIMARY 20 g Soy-related Stool Consistency |
0; 5; 2; 0; 0; 0 | — |
| PRIMARY 30 g Soy-related Stool Consistency |
0; 2; 4; 1; 0; 0 | — |
| SECONDARY 10 g Soy Intake Effect on Fecal Short Chain Fatty Acids |
5736.93 | — |
| SECONDARY 20 g Soy Intake Effect on Fecal Short Chain Fatty Acids |
6577.87 | — |
| SECONDARY 30 g Soy Intake Effect on Fecal Short Chain Fatty Acids |
6191.89 | — |
Eligibility Criteria
Inclusion Criteria
- Adult (70 - 85 years).
- Body mass index between 30 and 40 kg/m2.
- No evidence of diabetes (fasting blood sugar 25).
- No evidence of depression. (Geriatric Depression Scale-15 [GDS-15] 400 mg/dl.
- Clinically significant abnormal laboratory markers (as determined by the medical investigator).
- Subjects with anticipated surgery during the study period.
- 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.
Data sourced from ClinicalTrials.gov (NCT04499482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.