Resistant Starch Blend Gastrointestinal Impact

NCT03983772 | Completed DMC

• 1 other identifier: RSBGI-PLMC
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test the hypothesis that a unique blend of resistant starches and fiber will promote gastrointestinal health, as measured by an increase in short-chain fatty acids and improvement in quality of life measures in conjunction with microbial community changes. This study specifically evaluates the impact on short-chain fatty acids and gut microbiota and the impact on quality of life from a resistant starch blend in healthy adult humans with occasional gastrointestinal distress.

Conditions

Quality of Life; Health, Subjective

Keywords

Prebiotics; Resistant starch; Gut microbiota; Microbial diversity; Dietary fiber; Short-chain fatty acid; Gastrointestinal symptom; Dose-ramping design; Resistant starch blend; Fecal consistency; Fecal frequency; PROMIS; Microbiome analysis; Virtual; Remote access

Outcome Measures

Primary Outcomes (1)

• Change in Concentration of short-chain fatty acids from baseline to each product intervention

  Concentration of total short-chain fatty acids, including valerate, isovalerate and isobutyrate, and individually-reported n-butyrate concentration as well as propionate and acetate % will be reported by Genova Diagnostics Report

  Baseline (2 week period) compared to each product completion period of 2 weeks

Secondary Outcomes (4)

• Change in fecal frequency (hours between stools) from baseline at each intervention

  Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination)

• Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Diarrhea 6a)

  Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination)

• Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Constipation)

  Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination)

• Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Gas and Bloating 13a 09-02-2016)

  Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination)

Study Arms (4)

RS10-10-10

EXPERIMENTAL

First 2 weeks is for baseline variability measurement (no product). Second 2 weeks is 10 g resistant starch (RS) blend. Third 2 weeks is 10 g RS blend. Fourth 2 weeks is 10 g RS blend.

Dietary Supplement: RS blend

RS10-20-20

EXPERIMENTAL

First 2 weeks are for baseline variability measurement (no product). Second 2 weeks is 10 g resistant starch (RS) blend. Third 2 weeks is 20 g RS blend. Fourth 2 weeks is 20 g RS blend.

Dietary Supplement: RS blend

RS10-20-30

EXPERIMENTAL

First 2 weeks are for baseline variability measurement (no product). Second 2 weeks is 10 g resistant starch (RS) blend. Third 2 weeks is 20 g RS blend. Fourth 2 weeks is 30 g RS blend.

Dietary Supplement: RS blend

Placebo10-10-10

PLACEBO COMPARATOR

First 2 weeks are for baseline variability measurement (no product). Second 2 weeks is 10 g placebo. Third 2 weeks is 10 g placebo. Fourth 2 weeks is 10 g placebo.

Other: Placebo

Interventions

RS blend DIETARY_SUPPLEMENT

The intervention is a proprietary resistant starch blend.

RS10-10-10; RS10-20-20; RS10-20-30

Placebo OTHER

The placebo is starch.

Placebo10-10-10

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Currently taking a probiotic, resistant starch, prebiotic or fiber supplement (or they were taken within the last 14 days)
• Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within the last 28 days)
• Initiation of/or changes to supplements or medications within 28 days prior to screening
• Currently taking any supplements or medications impacting gastrointestinal motility (e.g., SSRI's, PPI's, opioids) (one exception is use of PPI's if the PPI use is stable, i.e., dosage and frequency is consistent, has not changed in the last month, and will not change during the course of the study. Such individuals may be included in the study at the discretion of the investigator)
• The use of any supplements or medications which influences digestion and absorption of nutrients
• No serious, unstable illnesses including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurologic, immunologic, or hematologic disease.
• Known infection with Human Immunodeficiency Virus (HIV), Tuberculosis or Hepatitis B or C.
• Known intolerance or allergy to ingredients in test study product
• Active and severe gastrointestinal symptoms and/or infections
• The presence of any disease which influences digestion and absorption of nutrients
• History of any bariatric surgery procedure within the last 5 years
• History of gastrointestinal surgery within the last 5 years
• Currently have a colostomy or ileostomy bag in place
• Genito-urinary bacterial infections within the last 28 days
• Any cardiovascular disease including myocardial infarction, angina, cardiovascular surgery, congestive heart failure, cardiac arrhythmias or conduction abnormalities, cerebrovascular accident, transient ischemic attack (TIA), or peripheral vascular disease, deep vein thrombosis or pulmonary embolus.

Sponsors & Collaborators

• Metagenics, Inc.: lead
• Personalized Lifestyle Medicine Center: collaborator
• National University of Natural Medicine: collaborator

Study Sites (1)

Personalized Lifestyle Medicine Center

Gig Harbor, Washington, 98332, United States

Location

Study Officials

• Noelle Patno, PhD

  Metagenics, Inc.

  PRINCIPAL INVESTIGATOR

• Joseph Lamb, MD

  PLMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind (subject)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 12, 2019
• Study Start: June 14, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)