Quality of LifeNCT03983772
Resistant Starch Blend Gastrointestinal Impact
A study testing RS blend in people with Quality of Life and Health, Subjective, run by Metagenics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Health, Subjective
- What is being tested?
- RS blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Willingness to maintain current lifestyle (diet and exercise) practices (other than avoiding or limiting alcohol)
- Willing to avoid alcohol during the study OR limit alcohol consumption to 1-2 glasses of light beer or wine for the 1-2 days after the stool collection for visits 2, 3 and 4 (Participants who choose to consume alcohol will be given List of Foods A and Participant Checklist A while others will be given the B versions)
- Willingness to give informed consent to participate in the study.
- Presence of minor symptoms of bloating or constipation or irregular bowel movements
- Willingness and ability to collect per the two stool test kit procedures 10 stool samples at home and ship per instructions
- Willing to have blood drawn 3 times (not applicable to those impacted by circumstances associated with COVID-19 pandemic)
- Ability to speak, read and understand English
- Ability to participate via telemedicine (phone or video calls for study visits and submit documents electronically and receive products and return unused products)
Exclusion criteria 4.1.1 Prohibited Medications, Supplements or Herbal Products Exclusionary
- 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
4.1.2 Medical History and Concurrent Diseases Exclusions
- 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.
- Any personal history of pre-Diabetes, Diabetes Mellitus Type 1 or 2 or hypoglycemia.
- Personal history of seizure disorder other than a single childhood febrile seizure that fully resolved.
- Any personal history of bipolar disorders, schizophrenia or psychotic behaviors.
- Any serious mental illness including depression, manic episodes, post-traumatic disorder, obsessive-compulsive disorder, personality disorders, history of attempted suicide or violence within 12 months prior to Screening and for the duration of the study.
- A major medical or surgical event requiring hospitalization (for any reason other than a scheduled medical procedure) within the preceding 3 months
- Malignancy within the last 5 years (with the exception of basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix)
- Women who are lactating, pregnant or planning pregnancy within the next three months 4.1.3 Substance Use Exclusions
- Smoking or use of nicotine containing products 30 days prior to Screening and for the duration of the study.
- History of alcohol abuse or a diagnosis of alcoholism within 12 months prior to Screening and for the duration of the study.
- Consumption of alcohol (or more than 4 glasses within the last 2 weeks if considered for the light alcohol use category, and no more than 2 glasses at once) for 14 days prior to Screening.
- Use of drugs of abuse and recreational drugs/substances (such as but not limited to opioids, cocaine, phencyclidine [PCP], and methamphetamine, including marijuana or cannabinoids) within 12 months prior to Screening and for the duration of the study.
4.1.4 Other Exclusionary Criteria
- Inability to comply with study and/or follow-up visits.
- Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance.
- Initiation of or changes to an exercise regimen within 28 days prior to screening
- Initiation of or changes to a food plan within 28 days prior to screening
- Current involvement or within 28 days prior to screening of a significant diet or weight loss program, such as NutriSystem, Jenny Craig, Atkin's or other low-carb diet programs, or very low calorie liquid diet programs (such as Optifast, Medifast, and/or HMR) or any diet that has led to a weight loss of 5% of body weight over a period of 10 weeks.
- Difficulty or aversion to taking powdered supplement
- Currently participating in another interventional research study or participated in another interventional study within the previous 28 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Personalized Lifestyle Medicine Center
Gig Harbor, Washington, 98332
About this study
Official title: A Pilot Study to Evaluate the Gastrointestinal Response to Increasing Doses of a Resistant Starch Blend in Healthy Subjects
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.
Read the detailed description
Low microbial diversity in the intestine correlates with chronic diseases such as Inflammatory Bowel diseases, colorectal cancer, obesity, Type 1 and Type 2 diabetes and more. The incidence of chronic diseases is greater in the industrialized society consuming a diet low in microbiota-accessible-carbohydrates. Thus, research is growing to seek prebiotics, which are substrates that host microbes selectively use, providing a health benefit.
Better-tolerated prebiotics may be desirable, particularly for those avoiding FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) due to gastrointestinal distress. Additionally, the intestinal microbiome may benefit from a diversity of prebiotics that may affect different types of bacteria to contribute to overall microbial diversity as well as provide stronger effects on positive outcomes. Resistant starch type 2, also called RS2, so named due to its ability to resist digestion in the upper gastrointestinal tract, is a candidate prebiotic, growing in popularity for increasing beneficial intestinal bacteria and improving gastrointestinal symptoms and reducing glycemic responses.
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
- Being tested
- RS blend, Placebo
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS blendDietary supplement
The intervention is a proprietary resistant starch blend.
PlaceboOther
The placebo is starch.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Fecal frequency (time in hours between stools) will be evaluated for each time period and compared between baseline (2 week period) and product intervention period (each 2 week period)
Measured: 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)
Response pattern score on PROMIS Scale v1.0 - GI Diarrhea will be compared between baseline and each intervention period
Measured: 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)
Response pattern score on PROMIS Scale v1.0 - GI Constipation will be compared between baseline and each intervention period
Measured: 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)
Response pattern score on PROMIS Scale v1.0 - GI Gas and Bloating 13a 09-02-2016 will be compared between baseline and each intervention period
Measured: Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start14 Jun 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metagenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Personalized Lifestyle Medicine Center, National University of Natural Medicine
- Responsible party
- Sponsor
- Investigators
- Noelle Patno, PhD, Principal investigator, Metagenics, Inc.Joseph Lamb, MD, Principal investigator, PLMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983772
- Sponsor's protocol ID
- RSBGI-PLMC
- Status last verified
- Apr 2022
- First submitted
- 7 Jun 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Gastrointestinal Response to Increasing Doses of a Resistant Starch Blend in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03983772
- Acronym / sponsor ID
- RSBGI-PLMC
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Metagenics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Personalized Lifestyle Medicine Center, National University of Natural Medicine
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Low microbial diversity in the intestine correlates with chronic diseases such as Inflammatory Bowel diseases, colorectal cancer, obesity, Type 1 and Type 2 diabetes and more. The incidence of chronic diseases is greater in the industrialized society consuming a diet low in microbiota-accessible-carbohydrates. Thus, research is growing to seek prebiotics, which are substrates that host microbes selectively use, providing a health benefit.
Better-tolerated prebiotics may be desirable, particularly for those avoiding FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) due to gastrointestinal distress. Additionally, the intestinal microbiome may benefit from a diversity of prebiotics that may affect different types of bacteria to contribute to overall microbial diversity as well as provide stronger effects on positive outcomes. Resistant starch type 2, also called RS2, so named due to its ability to resist digestion in the upper gastrointestinal tract, is a candidate prebiotic, growing in popularity for increasing beneficial intestinal bacteria and improving gastrointestinal symptoms and reducing glycemic responses.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RS10-10-10 | Experimental | Dietary Supplement: RS blendFirst 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. |
| RS10-20-20 | Experimental | Dietary Supplement: RS blendFirst 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. |
| RS10-20-30 | Experimental | Dietary Supplement: RS blendFirst 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. |
| Placebo10-10-10 | Placebo comparator | Other: PlaceboFirst 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RS blendThe intervention is a proprietary resistant starch blend. | Dietary supplement | RS10-10-10, RS10-20-20, RS10-20-30 |
| PlaceboThe placebo is starch. | Other | Placebo10-10-10 |
Primary outcome
Change in Concentration of short-chain fatty acids from baseline to each product intervention
Time frame: Baseline (2 week period) compared to each product completion period of 2 weeks
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
4 secondary outcomes
Change in fecal frequency (hours between stools) from baseline at each intervention
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noelle Patno, PhD principal investigator
Metagenics, Inc.
Joseph Lamb, MD principal investigator
PLMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RS blend in people with Quality of Life and Health, Subjective, run by Metagenics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Concentration of short-chain fatty acids from baseline to each product intervention (time frame: Baseline (2 week period) compared to each product completion period of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.