Safety and Tolerability of Soy Fiber

NCT04499482 | Completed Results DMC

• 2 other identifiers: PBRC 2020-0101K99AG065419-01A1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety Issues; Tolerance

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• 10 g Soy Intake Effect on Fecal Short Chain Fatty Acids

  One week

• 20 g Soy Intake Effect on Fecal Short Chain Fatty Acids

  One week

• 30 g Soy Intake Effect on Fecal Short Chain Fatty Acids

  One week

Study Arms (3)

Foods containing 10 g soy flour

EXPERIMENTAL

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

Foods containing 20 g soy flour

EXPERIMENTAL

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

Foods containing 30 g soy flour

EXPERIMENTAL

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

Other: Food

Interventions

Food OTHER

Soy-fiber containing food

Foods containing 10 g soy flour; Foods containing 20 g soy flour; Foods containing 30 g soy flour

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Candida Rebello
• Organization: Pennington Biomedical Research Center

Candida.Rebello@pbrc.edu

2252882411

Study Officials

• Candida Rebello, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Dose escalating cross over trial

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: October 4, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: May 18, 2023
• Results First Posted: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)