Safety and Tolerability of Soy Fiber

Pennington Biomedical Research Center

Status: Completed

Conditions: Tolerance; Safety Issues

Treatments: Other: Food

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04499482

PBRC 2020-010

1K99AG065419-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 70 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 3 patient groups

Foods containing 10 g soy flour

Experimental group

Description:

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.

Treatment:

Other: Food

Foods containing 20 g soy flour

Experimental group

Description:

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.

Treatment:

Other: Food

Foods containing 30 g soy flour

Experimental group

Description:

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

Treatment:

Other: Food