Clinical trial NCT04499482: Safety and Tolerability of Soy Fiber
Official title: Safety and Tolerability of Soy Fiber in the Elderly: A Dose Escalation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety Issues
Tolerance
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-08-05
Enrollment: 8
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Dose escalating cross over trial
Primary purpose: OTHER

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 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy
timeFrame: One week at each dose
measure: 10 g Soy-related Gastrointestinal Symptoms
timeFrame: One week
measure: 20 g Soy-related Gastrointestinal Symptoms
timeFrame: One week
measure: 30 g Soy-related Gastrointestinal Symptoms
timeFrame: One week
measure: 10 g Soy-related Stool Frequency
timeFrame: One week
measure: 20 g Soy-related Stool Frequency
timeFrame: One week
measure: 30 g Soy-related Stool Frequency
timeFrame: One week
measure: 10 Soy-related Stool Consistency
timeFrame: One week
measure: 20 g Soy-related Stool Consistency
timeFrame: One week
measure: 30 g Soy-related Stool Consistency
timeFrame: One week
Secondary outcomes:
measure: 10 g Soy Intake Effect on Fecal Short Chain Fatty Acids
timeFrame: One week
measure: 20 g Soy Intake Effect on Fecal Short Chain Fatty Acids
timeFrame: One week
measure: 30 g Soy Intake Effect on Fecal Short Chain Fatty Acids
timeFrame: One week
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Candida Rebello, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: