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: 1. 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. 2. 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. 3. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
96
Participants will consume 80 grams of carbohydrates from resistant starch during the meal challenges and two times daily during the 14-day intervention period
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
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
Clinical Trial Center, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
RECRUITINGPropionate
Differences in plasma propionate between strata at timepoint +360 min
Time frame: During meal challenge day (at the beginning of each intervention)
Glucose (7 h, between treatments)
Differences in glucose responses (from 7-hour meal challenge test) between dietary treatments during whole day for all participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During each intervention (14 days)
Glucose (home sampling)
Differences in glucose from home sampling between dietary treatments for all participants
Time frame: 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
Time frame: At the end of each 14-day intervention
CRP
Differences in inflammation biomarkers (CRP) between dietary treatments for all participants
Time frame: During meal challenge test (at the beginning of each intervention)
Blood lipids
Differences in blood lipids between dietary treatments for all participants
Time frame: 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
Time frame: During each intervention (fasting samples and meal challenge test)
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