Adults With Overweight and ObesityPerStarchNCT06897241
Personalized Metabolic Responses to Rapid, Slow and Resistant Starch
A study testing Resistant starch, Slow digestible starch and Rapid digestible starch in people with Adults With Overweight and Obesity, run by Chalmers University of Technology at 1 site in Sweden.
Trial summary
The study aims to investigate how individuals with varying gut microbiota composition and AMY1 gene copy number respond to three different types of starch. A 12-week trial will therefore be conducted, where all participants will go through three different 17-day interventions in a randomized order. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Adults With Overweight and Obesity
- What is being tested?
- Resistant starch, Slow digestible starch and Rapid digestible starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSweden
- Study dates
- 8 Apr 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and post-menopausal women
- Age 30-75 years
- BMI 27-40 kg/m2
- Waist circumference > 102/88 cm for men/women
- Weight stable during previous 3 months (± 3 kg)
- Willingness to consume the intervention diets
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- Ability to deal with the monitoring devices
- Medications stable for the previous 14 days
- Signed informed consent
Who cannot join
- Cardiovascular events (myocardial infarction or stroke) during the previous 6 months
- Diagnosis of diabetes (any type) or use of any drug who can interfere with glucose homeostasis (i.e., metformin, incretin analogues, SGLT-2 inhibitors)
- History of stomach or gastrointestinal conditions (inflammatory bowel disease, Crohn's disease, malabsorption, etc.)
- Colostomy, bowel resection, bariatric surgery or other major gastrointestinal surgery
- Renal or liver failure (creatinine <1.7 mg/dl and alanine aminotransferase/aspartate aminotransferase < 2 times than normal values, respectively)
- Anemia (hemoglobin below the age and sex specific normal reference ranges at screening)
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- Blood donation (or participation in a clinical study with blood sampling) within 30 days prior to inclusion
- Having been treated with antibiotics within the past 3 months or planning to undergo treatment during the study period.
- Habitual use of probiotic/prebiotic supplements or foods enriched in probiotics
- Celiac disease
- Vegan/vegetarian diet (or a diet incompatible with protocol diets)
- Intense physical activity regimen (> 7 h/week of moderate intensity or > 3 h/week of high intensity)
- History of drug or alcohol abuse
- Not able to understand written and spoken Swedish
- Any other reason for lack of suitability for participation in the trial, as judged by the principal investor or co-principal investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Clinical Trial Center, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 413 46
Anna Hjort, 0046317722848, anna.hjort@chalmers.se
About this study
Official title: Personalized Metabolic Responses to Rapid, Slow and Resistant Starch (PerStarch)
The study aims to investigate how individuals with varying gut microbiota composition and AMY1 gene copy number respond to three different types of starch. A 12-week trial will therefore be conducted, where all participants will go through three different 17-day interventions in a randomized order. Each intervention will contain a different type of starch:
- Resistant starch B) Slow digestible starch C) Rapid digestible starch
Read more
Each intervention will contain a preparation day, a meal challenge test day at clinic, a 14-day dietary intervention at home followed by a follow up visit at clinic. The interventions will be separated with a 14-day wash-out period, where participants are consuming their normal food.
Blood, saliva and fecal samples will be collected during the trial, together with data from continuous glucose monitoring and body measurements. Questionnaires on dietary intake and lifestyle, food preferences, self-reported appetite, health-related quality of life, sleep quality and daytime sleepiness will also be filled out by the participants.
Read the detailed description
Up to 400 men and women with overweight or obesity will be invited for screening. Participants will provide stool-, saliva-, and fasting blood samples, alongside undergoing anthropometric measurements. Gut microbiota will be analyzed from stool samples, while saliva samples will be used to determine AMY1 copy number. This data will then be used to categorize participants into four distinct groups, based on high or low Prevotella abundance and high or low AMY1 copy number.
Participants in all four groups will undergo a three-way cross-over feeding regime containing three different types of starch: A) resistant starch (RS), B) slow digestible starch (SDS) and C) rapid digestible starch (RDS). Each treatment will start with a "meal challenge day" at the clinic, where participants will eat test foods for breakfast, containing the different types of starch, followed by a standardized lunch. During the meal challenge day, blood samples will be collected over 7 hours along with continuous glucose monitoring, saliva sampling and self-reported appetite. During the following 14 days, participants will continue to consume the test foods A, B or C for lunch and dinner at home along with continuous glucose monitoring. The at home intervention will be followed up with a clinical visit, where fasting blood samples are taken before the breakfast from the meal challenge day is repeated. After the breakfast, participants will take finger prick blood samples from home during another 4 hours. Each intervention will be followed by a 14-day wash out period before the next treatment begins.
The specific aims with the trial are:
- To investigate differential metabolic responses (glycemia, blood lipids and inflammation biomarkers) in response to meal tolerance tests based on RS, SDS or RDS served for breakfast and dinner across individuals with high or low abundance of Prevotella and high or low AMY1 copy number.
- To evaluate metabolic effects of chronic consumption of RS and SDS versus RDS daily for two weeks across different enterotypes and in individuals with high or low AMY1 copy number.
- To evaluate a non-invasive method to measure redox potential in fecal samples. In exploratory analyses, the associations between fecal redox potential and responses to different starches as well as microbiota and other biomarkers will be investigated.
- Conditions
- Adults With Overweight and Obesity
- Being tested
- Resistant starch, Slow digestible starch, Rapid digestible starch
- Keywords
- Glucose metabolism, Prevotella, AMY1 copy number, Continuous glucose monitoring, Meal tolerance test, Fecal redox potential, Home sampling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant starchOther
Participants will consume 80 grams of carbohydrates from resistant starch during the meal challenges and two times daily during the 14-day intervention period
Slow digestible starchOther
Participants will consume 80 grams of carbohydrates from slow digestible starch during the meal challenges and two times daily during the 14-day intervention period
Rapid digestible starchOther
Participants will consume 80 grams of carbohydrates from rapid digestible starch during the meal challenges and two times daily during the 14-day intervention period
| Study group | Role | What they receive |
|---|---|---|
| Resistant starch | Experimental | Participants will consume 80 grams of carbohydrates from resistant starch during the meal challenges and two times daily during the 14-day intervention period Receives: Other: Resistant starch; Other: Slow digestible starch; Other: Rapid digestible starch |
| Slow digestible starch | Active comparator | Participants will consume 80 grams of carbohydrates from slow digestible starch during the meal challenges and two times daily during the 14-day intervention period Receives: Other: Resistant starch; Other: Slow digestible starch; Other: Rapid digestible starch |
| Rapid digestible starch | Other | Participants will consume 80 grams of carbohydrates from rapid digestible starch during the meal challenges and two times daily during the 14-day intervention period Receives: Other: Resistant starch; Other: Slow digestible starch; Other: Rapid digestible starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propionate
Differences in plasma propionate between strata at timepoint +360 min
Measured: During meal challenge day (at the beginning of each intervention)
Secondary outcomes (15)
Glucose (7 h, between treatments)
Differences in glucose responses (from 7-hour meal challenge test) between dietary treatments during whole day for all participants
Measured: During meal challenge day (at the beginning of each intervention)
Insulin (7 h, between treatments)
Differences in insulin responses (from 7-hour meal challenge test) between dietary treatments during whole day for all participants
Measured: During meal challenge day (at the beginning of each intervention)
Glucose (7 h, within treatments)
Differences in glucose responses (from 7-hour meal challenge test) across strata within the same dietary treatment
Measured: During meal challenge day (at the beginning of each intervention)
Insulin (7 h, within treatments)
Differences insulin responses (from 7-hour meal challenge test) across strata within the same dietary treatment
Measured: During meal challenge day (at the beginning of each intervention)
Glucose (4 h, breakfast, between treatments)
Differences in glucose between dietary treatments during breakfast meals separately for all participants
Measured: During meal challenge day (at the beginning of each intervention)
Insulin (4 h, breakfast, between treatments)
Differences in insulin between dietary treatments during breakfast meals separately for all participants
Measured: During meal challenge day (at the beginning of each intervention)
Glucose (4 h, breakfast, within treatments)
Differences in glucose during breakfast meals separately across strata within the same dietary treatment
Measured: During meal challenge day (at the beginning of each intervention)
Insulin (4 h, breakfast, within treatments)
Differences in insulin responses during breakfast meals separately across strata within the same dietary treatment
Measured: During meal challenge day (at the beginning of each intervention)
CGM (between treatments)
Differences in 24-hour CGM-measures and in the dynamic features of the postprandial glucose response as evaluated by CGM-home sampling between dietary treatments for all participants
Measured: During each intervention (14 days)
CGM (within treatments)
Differences in 24-hour CGM-measures and in the dynamic features of the postprandial glucose response as evaluated by CGM-home sampling between strata within dietary treatment
Measured: During each intervention (14 days)
Glucose (home sampling)
Differences in glucose from home sampling between dietary treatments for all participants
Measured: Att the end of each 14-day intervention
C-peptide (home sampling)
Differences in C-petide from home sampling between dietary treatments for all participants
Measured: At the end of each 14-day intervention
CRP
Differences in inflammation biomarkers (CRP) between dietary treatments for all participants
Measured: During meal challenge test (at the beginning of each intervention)
Blood lipids
Differences in blood lipids between dietary treatments for all participants
Measured: During each intervention (meal challenge test and home sampling)
Short chain fatty acids
Differences in short chain fatty acids (from feces and plasma) between dietary treatments for all participants
Measured: During each intervention (fasting samples and meal challenge test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start8 Apr 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults With Overweight and ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three-way cross-over design, where subjects are randomized to the order of the three different interventions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy, Göteborg University
- Responsible party
- Principal investigator, Rikard Landberg, Chalmers University of Technology
- Investigators
- Rikard Landberg, Principal investigator, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897241
- Sponsor's protocol ID
- PerStarch
- Acronym
- PerStarch
- Status last verified
- May 2025
- First submitted
- 20 Mar 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Metabolic Responses to Rapid, Slow and Resistant Starch (PerStarch)
- ClinicalTrials.gov ID
- NCT06897241
- Acronym / sponsor ID
- PerStarch / PerStarch
- Conditions
- Adults With Overweight and Obesity
- Keywords
- Glucose metabolism, Prevotella, AMY1 copy number, Continuous glucose monitoring, Meal tolerance test, Fecal redox potential, Home sampling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy, Göteborg University
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 26 Mar 2025 (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 study aims to investigate how individuals with varying gut microbiota composition and AMY1 gene copy number respond to three different types of starch. A 12-week trial will therefore be conducted, where all participants will go through three different 17-day interventions in a randomized order. Each intervention will contain a different type of starch:
- Resistant starch B) Slow digestible starch C) Rapid digestible starch
Each intervention will contain a preparation day, a meal challenge test day at clinic, a 14-day dietary intervention at home followed by a follow up visit at clinic. The interventions will be separated with a 14-day wash-out period, where participants are consuming their normal food.
Blood, saliva and fecal samples will be collected during the trial, together with data from continuous glucose monitoring and body measurements. Questionnaires on dietary intake and lifestyle, food preferences, self-reported appetite, health-related quality of life, sleep quality and daytime sleepiness will also be filled out by the participants.
Detailed description
Up to 400 men and women with overweight or obesity will be invited for screening. Participants will provide stool-, saliva-, and fasting blood samples, alongside undergoing anthropometric measurements. Gut microbiota will be analyzed from stool samples, while saliva samples will be used to determine AMY1 copy number. This data will then be used to categorize participants into four distinct groups, based on high or low Prevotella abundance and high or low AMY1 copy number.
Participants in all four groups will undergo a three-way cross-over feeding regime containing three different types of starch: A) resistant starch (RS), B) slow digestible starch (SDS) and C) rapid digestible starch (RDS). Each treatment will start with a "meal challenge day" at the clinic, where participants will eat test foods for breakfast, containing the different types of starch, followed by a standardized lunch. During the meal challenge day, blood samples will be collected over 7 hours along with continuous glucose monitoring, saliva sampling and self-reported appetite. During the following 14 days, participants will continue to consume the test foods A, B or C for lunch and dinner at home along with continuous glucose monitoring. The at home intervention will be followed up with a clinical visit, where fasting blood samples are taken before the breakfast from the meal challenge day is repeated. After the breakfast, participants will take finger prick blood samples from home during another 4 hours. Each intervention will be followed by a 14-day wash out period before the next treatment begins.
The specific aims with the trial are:
- To investigate differential metabolic responses (glycemia, blood lipids and inflammation biomarkers) in response to meal tolerance tests based on RS, SDS or RDS served for breakfast and dinner across individuals with high or low abundance of Prevotella and high or low AMY1 copy number.
- To evaluate metabolic effects of chronic consumption of RS and SDS versus RDS daily for two weeks across different enterotypes and in individuals with high or low AMY1 copy number.
- To evaluate a non-invasive method to measure redox potential in fecal samples. In exploratory analyses, the associations between fecal redox potential and responses to different starches as well as microbiota and other biomarkers will be investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-way cross-over design, where subjects are randomized to the order of the three different interventions
| Arm | Type | Receives |
|---|---|---|
| Resistant starch | Experimental | Other: Resistant starch, Other: Slow digestible starch, Other: Rapid digestible starchParticipants will consume 80 grams of carbohydrates from resistant starch during the meal challenges and two times daily during the 14-day intervention period |
| Slow digestible starch | Active comparator | Other: Resistant starch, Other: Slow digestible starch, Other: Rapid digestible starchParticipants will consume 80 grams of carbohydrates from slow digestible starch during the meal challenges and two times daily during the 14-day intervention period |
| Rapid digestible starch | Other | Other: Resistant starch, Other: Slow digestible starch, Other: Rapid digestible starchParticipants will consume 80 grams of carbohydrates from rapid digestible starch during the meal challenges and two times daily during the 14-day intervention period |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and post-menopausal women
- Age 30-75 years
- BMI 27-40 kg/m2
- Waist circumference > 102/88 cm for men/women
- Weight stable during previous 3 months (± 3 kg)
Key exclusion criteria (15 listed)
- Cardiovascular events (myocardial infarction or stroke) during the previous 6 months
- Diagnosis of diabetes (any type) or use of any drug who can interfere with glucose homeostasis (i.e., metformin, incretin analogues, SGLT-2 inhibitors)
- History of stomach or gastrointestinal conditions (inflammatory bowel disease, Crohn's disease, malabsorption, etc.)
- Colostomy, bowel resection, bariatric surgery or other major gastrointestinal surgery
- Renal or liver failure (creatinine <1.7 mg/dl and alanine aminotransferase/aspartate aminotransferase < 2 times than normal values, respectively)
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 starchParticipants will consume 80 grams of carbohydrates from resistant starch during the meal challenges and two times daily during the 14-day intervention period | Other | Rapid digestible starch, Resistant starch, Slow digestible starch |
| Slow digestible starchParticipants will consume 80 grams of carbohydrates from slow digestible starch during the meal challenges and two times daily during the 14-day intervention period | Other | Rapid digestible starch, Resistant starch, Slow digestible starch |
| Rapid digestible starchParticipants will consume 80 grams of carbohydrates from rapid digestible starch during the meal challenges and two times daily during the 14-day intervention period | Other | Rapid digestible starch, Resistant starch, Slow digestible starch |
Primary outcome
Propionate
Time frame: During meal challenge day (at the beginning of each intervention)
Differences in plasma propionate between strata at timepoint +360 min
15 secondary outcomes
Glucose (7 h, between treatments)
Time frame: During meal challenge day (at the beginning of each intervention)
Insulin (7 h, between treatments)
Time frame: During meal challenge day (at the beginning of each intervention)
Glucose (7 h, within treatments)
Time frame: During meal challenge day (at the beginning of each intervention)
Insulin (7 h, within treatments)
Time frame: During meal challenge day (at the beginning of each intervention)
Glucose (4 h, breakfast, between treatments)
Time frame: During meal challenge day (at the beginning of each intervention)
Insulin (4 h, breakfast, between treatments)
Time frame: During meal challenge day (at the beginning of each intervention)
Glucose (4 h, breakfast, within treatments)
Time frame: During meal challenge day (at the beginning of each intervention)
Insulin (4 h, breakfast, within treatments)
Time frame: During meal challenge day (at the beginning of each intervention)
CGM (between treatments)
Time frame: During each intervention (14 days)
CGM (within treatments)
Time frame: During each intervention (14 days)
Glucose (home sampling)
Time frame: Att the end of each 14-day intervention
C-peptide (home sampling)
Time frame: At the end of each 14-day intervention
CRP
Time frame: During meal challenge test (at the beginning of each intervention)
Blood lipids
Time frame: During each intervention (meal challenge test and home sampling)
Short chain fatty acids
Time frame: During each intervention (fasting samples and meal challenge test)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Rikard Landberg principal investigator
Chalmers University of Technology
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, Slow digestible starch and Rapid digestible starch in people with Adults With Overweight and Obesity, run by Chalmers University of Technology at 1 site in Sweden.
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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 16 May 2025. 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 Sweden. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Hjort (0046317722848, anna.hjort@chalmers.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propionate (time frame: During meal challenge day (at the beginning of each intervention)). 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 16 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.