Safety and Tolerability of Soy Fiber
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Foods containing 10 g soy flour Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week. |
Other: Food
Soy-fiber containing food
|
| Experimental: Foods containing 20 g soy flour Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week. |
Other: Food
Soy-fiber containing food
|
| Experimental: Foods containing 30 g soy flour Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week. |
Other: Food
Soy-fiber containing food
|
Outcome Measures
Primary Outcome Measures
- Incidence of Treatment-emergent Adverse Events following each dose of soy [Three weeks during which each escalating dose will be ingested for one week.]
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 [One week]
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
- 20 g soy-related gastrointestinal symptoms [One week]
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
- 30 g soy-related gastrointestinal symptoms [One week]
Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
- 10 g soy-related stool frequency [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 [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 stood frequency [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 [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
- 20 g soy-related stool consistency [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
- 30 g soy-related stool consistency [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
Secondary Outcome Measures
- 10 g soy-related compliance [One week]
Measurement of fecal short chain fatty acids.
- 20 g soy-related compliance [One week]
Measurement of fecal short chain fatty acids.
- 30 g soy-related compliance [One week]
Measurement of fecal short chain fatty acids.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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).
Exclusion Criteria:
-
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.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pennington Biomedical Research Center | Baton Rouge | Louisiana | United States | 70808 |
Sponsors and Collaborators
- Pennington Biomedical Research Center
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Candida Rebello, Ph.D., Pennington Biomedical Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-010
- 1K99AG065419-01A1