Diet ModificationNCT03255603
Gastrointestinal Assessment of Three Novel RS4
A study testing Resistant Starch Type 4 Supplementation and Digestible Starch Supplementation in people with Diet Modification, run by University of Alberta at 1 site in Canada.
Trial summary
The rates of chronic diseases like obesity, diabetes, and heart disease are rising across the world. This is especially true in industrialized countries like Canada and the USA. Even though there are many possible causes for these increases. One prominent cause is our refined diet, which greatly lacks dietary fiber. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Resistant Starch Type 4 Supplementation and Digestible Starch Supplementation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 22 Dec 2018
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- men and pre-menopausal, non-pregnant or non-lactating women
- non-vegetarian
- non-smoking
- alcohol intake ≤8 drinks/week
- ≤5 h/week of moderate-vigorous exercise
Who cannot join
- acute or chronic GI illnesses, conditions, or issues
- history of GI surgical intervention
- chronic or current use of anti-hypertensive, lipid-lowering, anti-diabetic, analgesic, or laxative medications
- antibiotic treatment in the last 3 months
- use of fiber or probiotics supplements
- allergies or intolerances to fiber sources
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alberta Diabetes Institute Clinical Research Unit
Edmonton, Alberta, T6G 2E1
About this study
Official title: Gastrointestinal Assessment of Three Novel Resistant Starch Type IV
The rates of chronic diseases like obesity, diabetes, and heart disease are rising across the world. This is especially true in industrialized countries like Canada and the USA. Even though there are many possible causes for these increases. One prominent cause is our refined diet, which greatly lacks dietary fiber. This 'fiber gap' between the amount of fiber actually eaten and the amount that should be eaten is likely promoting these diseases.
It is known that a high fiber diet can benefit health and the health of the gut bacteria. It is also know that these gut microbes can help cause and prevent diseases. When fiber is eaten, it gets broken down not by us, but by our gut microbes. During this process by-products called short-chain fatty acids (SCFA) are made. These SCFA have been shown to promote health. Therefore, it is thought that fiber changes the gut microbes to produce more SCFA, which may improve overall health.
In order to aid our microbes and improve our health we need to find ways to reduce this 'fiber gap'. One possibility is to add fiber to our refined diet. To do so we must first learn how different fibers perform in our gut. This includes how our gut tolerates increasing amounts of fiber, and how our microbes respond. The purpose of this study is to learn how different types of resistant starch perform in our gut, including gastrointestinal tolerance. By doing so we will determine the ideal dose and type of these fibers to use in future studies.
Read the detailed description
The investigators propose a 4 week gastrointestinal (GI) assessment study to determine both the ideal dose and type of resistant starch to use in future studies. The following specific aims are offered:
AIM 1: GI Tolerance. Preform a randomized, placebo-controlled, double-blind, parallel-four-arm human intervention study to assess the GI tolerance of 3 novel resistant starch type IV (RS4) at dose up to 50 g per day.
Interested participants will be asked to attend a screening visit at Human Nutrition Research Unit, where lifestyle and anthropometric information will be collected to determine eligibility. Eligible participants (N = 40) will be stratified based on gender and randomly assigned to 1 of 4 groups, where they will be asked to supplement their diet for 4 weeks with either a RS4 (experimental arms) or a digestible starch (control arm). The weight of total starch (digestible plus RS) provided in each experimental arm will be dependent on the purity of the individual RS4 products. Subjects will supplement their diet with 10 g, 20 g, 35 g and 50 g of total dietary fiber (as RS) daily over the course of weeks 1, 2, 3 and 4, respectively. The amount of digestible starch provided in the control arm will be equal to the mean amount of total starch provided across the 3 experimental arms. All starch products will be provided in powder form.
Methodologies previously described by Maki et al. will be employed to evaluate the overall GI tolerance of the RS4 products by assessing changes in GI symptom, bowel movement frequency, and bowel movement consistency, and by comparing these changes to those changes observed in the control arm (digestible starch - Maki et al., Int J Food Sci Nutr, 2013). Participants will keep a daily study journal, which included a bowel habits questionnaire, over the course of the 4 week study, and they will also complete weekly GI tolerance and satiety questionnaires during their weekly study visits. Participants will also be asked to complete two 24-h recalls, both prior to starting the dietary intervention and during week 4. All 24-h recalls will be completed online through the Canadian Automated Self-Administered 24h (ASA24) recall system.
AIM 2: Evaluate prebiotic and dose dependent effect on the microbiome. Evaluate the effect of the 3 distinct RS4 types on gut microbiota composition and structure in a dose dependent manner.
Fecal samples will be collected at baseline and at the end of each intervention week (weeks 1-4). Fecal samples will be used to both characterize the fecal microbial community via 16S ribosomal RNA next-generation sequencing, and to quantify fecal short-chain fatty acid concentrations via gas chromatography. Short-term characterization of the fecal microbiome will provide a systematic assessment of the individualized response between 3 structurally distinct types of RS4, while further allowing an intricate assessment of the prebiotic dose effect upon significantly increasing the dose of RS towards 50 g per day. This analysis will provide critical information on how distinct types of RS4 shape the gut microbiome in humans, and which dose is necessary to achieve such effects.
- Conditions
- Diet Modification
- Being tested
- Resistant Starch Type 4 Supplementation, Digestible Starch Supplementation
- Keywords
- Resistant Starch, Dietary Fiber, Gastrointestinal Microbiome, Gastrointestinal Tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant Starch Type 4 SupplementationOther
Also called Modified potato starch
Ten participants will supplement their normal dietary intake with RS4 daily for four consecutive weeks, with each week the amount of RS4 provided being increased (10 g, 20 g, 35 g and 50 g/day).
Resistant Starch Type 4 SupplementationOther
Also called Modified corn starch
Ten participants will supplement their normal dietary intake with RS4 daily for four consecutive weeks, with each week the amount of RS4 provided being increased (10 g, 20 g, 35 g and 50 g/day).
Resistant Starch Type 4 SupplementationOther
Also called Modified tapioca starch
Ten participants will supplement their normal dietary intake with RS4 daily for four consecutive weeks, with each week the amount of RS4 provided being increased (10 g, 20 g, 35 g and 50 g/day).
Digestible Starch SupplementationOther
Also called Corn starch
Ten participants will supplement their normal dietary intake with digestible starch daily for four consecutive weeks, with each week the amount of starch provided being increased.
| Study group | Role | What they receive |
|---|---|---|
| Modified potato starch | Experimental | Modified potato starch is a resistant starch type IV and will be used as an experimental arm. Receives: Other: Resistant Starch Type 4 Supplementation |
| Modified corn starch | Experimental | Modified corn starch is a resistant starch type IV and will be used as an experimental arm. Receives: Other: Resistant Starch Type 4 Supplementation |
| Modified tapioca starch | Experimental | Modified tapioca starch is a resistant starch type IV and will be used as an experimental arm. Receives: Other: Resistant Starch Type 4 Supplementation |
| Corn starch | Placebo comparator | Corn starch is digestible and will therefore will be used as a placebo control for the study. Receives: Other: Digestible Starch Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Tolerance
Gastrointestinal tolerance will be assessed at weeks 0-4 of fiber intervention with a weekly gastrointestinal tolerability questionnaire.
Measured: 4-week period
Secondary outcomes (3)
Gastrointestinal Habits
Gastrointestinal habits will be assessed at weeks 0-4 of fiber intervention with a weekly bowel habit questionnaire.
Measured: 4-week period
Gastrointestinal Microbiome Composition
Fecal microbial composition will be characterized at weeks 0-4 of fiber intervention by 16S rRNA sequencing.
Measured: 4-week period
Gastrointestinal Microbiome Function
Fecal microbial function will be assessed at weeks 0-4 of fiber intervention through fecal SCFA concentrations.
Measured: 4-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start1 Sep 2017
- Primary completion28 Feb 2018
- Study completion22 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Walter, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255603
- Sponsor's protocol ID
- Pro00069884
- Status last verified
- May 2020
- First submitted
- 15 Aug 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Assessment of Three Novel Resistant Starch Type IV
- ClinicalTrials.gov ID
- NCT03255603
- Acronym / sponsor ID
- Pro00069884
- Conditions
- Diet Modification
- Keywords
- Resistant Starch, Dietary Fiber, Gastrointestinal Microbiome, Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 22 Dec 2018 (actual)
- First posted
- 21 Aug 2017 (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.
The rates of chronic diseases like obesity, diabetes, and heart disease are rising across the world. This is especially true in industrialized countries like Canada and the USA. Even though there are many possible causes for these increases. One prominent cause is our refined diet, which greatly lacks dietary fiber. This 'fiber gap' between the amount of fiber actually eaten and the amount that should be eaten is likely promoting these diseases.
It is known that a high fiber diet can benefit health and the health of the gut bacteria. It is also know that these gut microbes can help cause and prevent diseases. When fiber is eaten, it gets broken down not by us, but by our gut microbes. During this process by-products called short-chain fatty acids (SCFA) are made. These SCFA have been shown to promote health. Therefore, it is thought that fiber changes the gut microbes to produce more SCFA, which may improve overall health.
In order to aid our microbes and improve our health we need to find ways to reduce this 'fiber gap'. One possibility is to add fiber to our refined diet. To do so we must first learn how different fibers perform in our gut. This includes how our gut tolerates increasing amounts of fiber, and how our microbes respond. The purpose of this study is to learn how different types of resistant starch perform in our gut, including gastrointestinal tolerance. By doing so we will determine the ideal dose and type of these fibers to use in future studies.
Detailed description
The investigators propose a 4 week gastrointestinal (GI) assessment study to determine both the ideal dose and type of resistant starch to use in future studies. The following specific aims are offered:
AIM 1: GI Tolerance. Preform a randomized, placebo-controlled, double-blind, parallel-four-arm human intervention study to assess the GI tolerance of 3 novel resistant starch type IV (RS4) at dose up to 50 g per day.
Interested participants will be asked to attend a screening visit at Human Nutrition Research Unit, where lifestyle and anthropometric information will be collected to determine eligibility. Eligible participants (N = 40) will be stratified based on gender and randomly assigned to 1 of 4 groups, where they will be asked to supplement their diet for 4 weeks with either a RS4 (experimental arms) or a digestible starch (control arm). The weight of total starch (digestible plus RS) provided in each experimental arm will be dependent on the purity of the individual RS4 products. Subjects will supplement their diet with 10 g, 20 g, 35 g and 50 g of total dietary fiber (as RS) daily over the course of weeks 1, 2, 3 and 4, respectively. The amount of digestible starch provided in the control arm will be equal to the mean amount of total starch provided across the 3 experimental arms. All starch products will be provided in powder form.
Methodologies previously described by Maki et al. will be employed to evaluate the overall GI tolerance of the RS4 products by assessing changes in GI symptom, bowel movement frequency, and bowel movement consistency, and by comparing these changes to those changes observed in the control arm (digestible starch - Maki et al., Int J Food Sci Nutr, 2013). Participants will keep a daily study journal, which included a bowel habits questionnaire, over the course of the 4 week study, and they will also complete weekly GI tolerance and satiety questionnaires during their weekly study visits. Participants will also be asked to complete two 24-h recalls, both prior to starting the dietary intervention and during week 4. All 24-h recalls will be completed online through the Canadian Automated Self-Administered 24h (ASA24) recall system.
AIM 2: Evaluate prebiotic and dose dependent effect on the microbiome. Evaluate the effect of the 3 distinct RS4 types on gut microbiota composition and structure in a dose dependent manner.
Fecal samples will be collected at baseline and at the end of each intervention week (weeks 1-4). Fecal samples will be used to both characterize the fecal microbial community via 16S ribosomal RNA next-generation sequencing, and to quantify fecal short-chain fatty acid concentrations via gas chromatography. Short-term characterization of the fecal microbiome will provide a systematic assessment of the individualized response between 3 structurally distinct types of RS4, while further allowing an intricate assessment of the prebiotic dose effect upon significantly increasing the dose of RS towards 50 g per day. This analysis will provide critical information on how distinct types of RS4 shape the gut microbiome in humans, and which dose is necessary to achieve such effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Modified potato starch | Experimental | Other: Resistant Starch Type 4 SupplementationModified potato starch is a resistant starch type IV and will be used as an experimental arm. |
| Modified corn starch | Experimental | Other: Resistant Starch Type 4 SupplementationModified corn starch is a resistant starch type IV and will be used as an experimental arm. |
| Modified tapioca starch | Experimental | Other: Resistant Starch Type 4 SupplementationModified tapioca starch is a resistant starch type IV and will be used as an experimental arm. |
| Corn starch | Placebo comparator | Other: Digestible Starch SupplementationCorn starch is digestible and will therefore will be used as a placebo control for the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- men and pre-menopausal, non-pregnant or non-lactating women
- non-vegetarian
- non-smoking
- alcohol intake ≤8 drinks/week
- ≤5 h/week of moderate-vigorous exercise
Key exclusion criteria (6 listed)
- acute or chronic GI illnesses, conditions, or issues
- history of GI surgical intervention
- chronic or current use of anti-hypertensive, lipid-lowering, anti-diabetic, analgesic, or laxative medications
- antibiotic treatment in the last 3 months
- use of fiber or probiotics supplements
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 |
|---|---|---|
| Resistant Starch Type 4 SupplementationAlso: Modified potato starchTen participants will supplement their normal dietary intake with RS4 daily for four consecutive weeks, with each week the amount of RS4 provided being increased (10 g, 20 g, 35 g and 50 g/day). | Other | Modified potato starch |
| Resistant Starch Type 4 SupplementationAlso: Modified corn starchTen participants will supplement their normal dietary intake with RS4 daily for four consecutive weeks, with each week the amount of RS4 provided being increased (10 g, 20 g, 35 g and 50 g/day). | Other | Modified corn starch |
| Resistant Starch Type 4 SupplementationAlso: Modified tapioca starchTen participants will supplement their normal dietary intake with RS4 daily for four consecutive weeks, with each week the amount of RS4 provided being increased (10 g, 20 g, 35 g and 50 g/day). | Other | Modified tapioca starch |
| Digestible Starch SupplementationAlso: Corn starchTen participants will supplement their normal dietary intake with digestible starch daily for four consecutive weeks, with each week the amount of starch provided being increased. | Other | Corn starch |
Primary outcome
Gastrointestinal Tolerance
Time frame: 4-week period
Gastrointestinal tolerance will be assessed at weeks 0-4 of fiber intervention with a weekly gastrointestinal tolerability questionnaire.
3 secondary outcomes
Gastrointestinal Habits
Time frame: 4-week period
Gastrointestinal Microbiome Composition
Time frame: 4-week period
Gastrointestinal Microbiome Function
Time frame: 4-week period
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 19 Sep 2024.
- 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.
Jens Walter, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant Starch Type 4 Supplementation and Digestible Starch Supplementation in people with Diet Modification, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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 19 Sep 2024. 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 Canada. 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?
Gastrointestinal Tolerance (time frame: 4-week period). 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 19 Sep 2024.