Status:
COMPLETED
Safety and Tolerability of Soy Fiber
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Safety Issues
Tolerance
Eligibility:
All Genders
70-85 years
Phase:
NA
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04499482
Start Date
October 4 2021
End Date
April 14 2022
Last Update
May 18 2023
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808