Safety and Tolerability of Soy Fiber

NCT ID: NCT04499482

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2022-04-14

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.

Conditions

Safety Issues; Tolerance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Soy-fiber containing food

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.

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Soy-fiber containing food

Foods containing 30 g soy flour

Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Soy-fiber containing food

Interventions

Food

Soy-fiber containing food

Intervention Type: OTHER

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.

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Candida Rebello

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Candida Rebello, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1K99AG065419-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBRC 2020-010

Identifier Type: -

Identifier Source: org_study_id