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| Name | Class |
|---|---|
| Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy | UNKNOWN |
| Göteborg University | OTHER |
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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:
A) 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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistant starch | Other | Participants will consume 80 grams of carbohydrates from resistant starch during the meal challenges and two times daily during the 14-day intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Propionate | Differences in plasma propionate between strata at timepoint +360 min | During meal challenge day (at the beginning of each intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose (7 h, between treatments) | Differences in glucose responses (from 7-hour meal challenge test) between dietary treatments during whole day for all participants | During meal challenge day (at the beginning of each intervention) |
| Insulin (7 h, between treatments) |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolomics | Differences in metabolomics from 7-hour meal challenge test between dietary treatments for all participants | During meal challenge day (at the beginning of each intervention) |
| GLP-1 | Differences in GLP1 from 7-hour meal challenge test between dietary treatments for all participants |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Hjort | Contact | 0046317722848 | anna.hjort@chalmers.se | |
| Rikard Landberg | Contact | 0046317722732 | rikard.landberg@chalmers.se |
| Name | Affiliation | Role |
|---|---|---|
| Rikard Landberg | Chalmers University of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Sahlgrenska University Hospital | Recruiting | Gothenburg | Västra Götaland County | 413 46 | Sweden |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000084922 | Resistant Starch |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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Three-way cross-over design, where subjects are randomized to the order of the three different interventions
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| Slow digestible starch | Other | 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 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 |
|
Differences in insulin responses (from 7-hour meal challenge test) between dietary treatments during whole day for all participants |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | During each intervention (14 days) |
| Glucose (home sampling) | Differences in glucose from home sampling between dietary treatments for all participants | 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 | At the end of each 14-day intervention |
| CRP | Differences in inflammation biomarkers (CRP) between dietary treatments for all participants | During meal challenge test (at the beginning of each intervention) |
| Blood lipids | Differences in blood lipids between dietary treatments for all participants | 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 | During each intervention (fasting samples and meal challenge test) |
| During meal challenge day (at the beginning of each intervention) |
| GIP | Differences in GIP from 7-hour meal challenge test between dietary treatments for all participants | During meal challenge day (at the beginning of each intervention) |
| Anthropometry | Differences in anthropometric measures between dietary treatments for all participants | During each intervention (14 days) |
| Sleep quality | Differences in sleep quality between dietary treatments for all participants (measured with Pittsburgh Sleep Quality Index). The result is presented as a global sleep score on a 0-21 scale. A higher score indicates worse sleep quality and a value > 5 is classified as "poor sleep". For the areas subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction, component scores can also be calculated, each on a 0-3 AU scale. | During each intervention (14 days) |
| Daytime sleepiness | Differences in daytime sleepiness between dietary treatments for all participants (measured with Epworth Sleepiness Scale). The result is presented as an ESS-score on a 0-24 scale, where a higher score indicates greater daytime sleepiness. A value > 10 is classified as excessive daytime sleepiness. | During each intervention (14 days) |
| Health-related quality of life | Differences in health-related quality of life between dietary treatments for all participants (measured with SF-36v2). Domain scores are calculated for the areas physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional health and mental health. These can be presented either on a 0-100 scale of arbitrary units (raw scores) or as a norm-based T-score (with a mean of 50 AU and a standard deviation of 10). A higher score indicates greater HRQoL. T-scores are also calculated for the aggregated dimensions of physical- and mental health. | During each intervention (14 days) |
| Self-reported appetite | Differences in self-reported appetite between dietary treatments for all participants (measured with visual analogue scales). Participants will assess subjective feelings of appetite such as hunger, desire to eat and fullness by marking on a 100 mm scale with end descriptions ranging from "Not at all" (0) to "Extremely" (100). | During meal challenge test (at the beginning of each intervention) |
| Fecal redox potential and metabolic responses | Associations between fecal redox potential and responses to different starches | During each intervention (14 days) |
| Fecal redox potential and microbiota | Associations between fecal redox potential and microbiota | During each intervention (14 days) |
| Fecal redox potential and clinical biomarkers | Associations between fecal redox potential and clinical biomarkers | At baseline |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Macromolecular Substances |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |