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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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