Safety and Tolerability of Soy Fiber

Safety Issues Clinical Trial

Official title:

Safety and Tolerability of Soy Fiber in the Elderly: A Dose Escalation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499482
• Other study ID #: PBRC 2020-010
• Secondary ID: 1K99AG065419-01A
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: April 14, 2022

Study information

• Verified date: May 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Safety Issues
• Tolerance

Intervention

Other:
• Food
Soy-fiber containing food

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One week at each dose
Primary	10 g Soy-related Gastrointestinal Symptoms	Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.	One week
Primary	20 g Soy-related Gastrointestinal Symptoms	Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.	One week
Primary	30 g Soy-related Gastrointestinal Symptoms	Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.	One week
Primary	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	One week
Primary	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	One week
Primary	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	One week
Primary	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.	One week
Primary	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.	One week
Primary	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.	One week
Secondary	10 g Soy Intake Effect on Fecal Short Chain Fatty Acids	Measurement of fecal short chain fatty acids in response to intake of soy	One week
Secondary	20 g Soy Intake Effect on Fecal Short Chain Fatty Acids	Measurement of fecal short chain fatty acids in response to intake of soy	One week
Secondary	30 g Soy Intake Effect on Fecal Short Chain Fatty Acids	Measurement of fecal short chain fatty acids in response to intake of soy	One week