Safety and Tolerability of Soy Fiber

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

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.

Study Overview

• Status: Completed
• Conditions: Tolerance; Safety Issues
• Intervention / Treatment: Other: Food

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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. If they tolerate the dose, they will receive the next dose without any wash-out period.	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. If they tolerate the dose, they will receive the next dose without any wash-out period.	Other: Food; Soy-fiber containing food
Experimental: Foods containing 30 g soy flour; Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.	Other: Food; Soy-fiber containing food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
10 g Soy-related Gastrointestinal Symptoms	Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.	One week
20 g Soy-related Gastrointestinal Symptoms	Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.	One week
30 g Soy-related Gastrointestinal Symptoms	Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.	One week
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Candida Rebello, Ph.D., Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): April 14, 2022
• Study Completion (Actual): April 14, 2022

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PBRC 2020-010; 1K99AG065419-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No