Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome

NCT02656056 | Completed Phase 1

• 1 other identifier: 1507016139
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The consumption of fermented soy foods can alter the human microbiome and may confer health benefits. Researchers propose a line of inquiry to assess the effects of Q-Can Plus ("QC") fermented soy beverage in humans, assessing immunological, microbiological, and clinical parameters.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Change in microbiome species proportion- Oral

  Microbiome analysis will be conducted by calculating the significance in changes in the proportion of species between the groups, and by principal component analysis (PCA) to identify patterns of shift in the microbiome populations in relation to QC-induced changes.

  baseline to week 12

• Change in microbiome species proportion- Intestinal

  Microbiome analysis will be conducted by calculating the significance in changes in the proportion of species between the groups, and by principal component analysis (PCA) to identify patterns of shift in the microbiome populations in relation to QC-induced changes.

  baseline to week 12

Secondary Outcomes (6)

• Change in activation of the inflammasome machinery in peripheral blood cells with Pro-Il-1β

  baseline to week 12

• Change in activation of the inflammasome machinery in peripheral blood cells with Pro-TNF-α

  baseline to week 12

• Change in activation of the inflammasome machinery in peripheral blood cells with caspase-1 cleavage

  baseline to week 12

• Change in activation of the inflammasome machinery in peripheral blood cells with IL-1β

  baseline to week 12

• Change in activation of the inflammasome machinery in peripheral blood cells with TNF-α

  baseline to week 12

Other Outcomes (4)

• 24-hour Dietary Recall

  2 weeks prior to baseline (at baseline)

• 24-hour Dietary Recall

  baseline

• 24-hour Dietary Recall

  4 weeks

Study Arms (2)

Lean Adults

EXPERIMENTAL

Adults with a BMI between 21-25 will consume 8 oz of the fermented soybean beverage, twice daily.

Other: Food: (Q-Can Plus fermented soybean beverage)

Obese Adults

EXPERIMENTAL

Adults with a BMI between 32-37 will consume 8 oz of the fermented soybean beverage, twice daily.

Other: Food: (Q-Can Plus fermented soybean beverage)

Interventions

Food: (Q-Can Plus fermented soybean beverage) OTHER

Fermented soybean beverage. Dose is 8 oz, twice daily.

Lean Adults; Obese Adults

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (aged between 18 and 70) that are obese (BMI 32-37) (n=10)
• Adults (aged between 18 and 70) that are lean (BMI 21-25) (n=10)

You may not qualify if:

• Allergy to soy or soy derivatives.
• Patients will be excluded if they had abdominal surgeries (excluding cholecystectomy, appendectomy, hysterectomy, and hernia repair).
• History of inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) and/or gastrointestinal bleeding.
• Medications: Antibiotics, probiotics, or systemic corticosteroids (within 6 months of enrollment).
• Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function.
• Patients will be excluded if using medications which are known to be affected by modest dietary changes. This will include, but is not limited to, warfarin and immunosuppressives such as cyclosporin.
• Alcohol use disorder, anorexia nervosa, autoimmune disease, bulimia, celiac disease, chronic infections, and illicit drug use.
• Major changes in dietary habits in past six months.
• Pregnancy or intent to get pregnant during study period
• Use of tobacco, including cigarettes, smokeless tobacco, cigars, and pipes within 30 days of enrollment.

Sponsors & Collaborators

• Yale University: lead
• BESO Biological Research, Inc.: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• Dioletis E, Paiva RS, Kaffe E, Secor ER, Weiss TR, Fields MR, Ouyang X, Ali A. The fermented soy beverage Q-CAN(R) plus induces beneficial changes in the oral and intestinal microbiome. BMC Nutr. 2021 Mar 4;7(1):6. doi: 10.1186/s40795-021-00408-4.

  PMID: 33658080 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Food

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Eugene Shapiro, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Wajahat Mehal, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 14, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)