About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and post-menopausal women
Age 30-75 years
BMI 27-40 kg/m2
Waist circumference > 102/88 cm for men/women
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Resistant starch
Other interventionParticipants 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
Other interventionParticipants 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 interventionParticipants will consume 80 grams of carbohydrates from rapid digestible starch during the meal challenges and two times daily during the 14-day intervention period
Treatment groups
Trial outcomes
Primary outcomes
Propionate
Differences in plasma propionate between strata at timepoint +360 min
Secondary outcomes
Glucose (7 h, between treatments)
Differences in glucose responses (from 7-hour meal challenge test) between dietary treatments during whole day for all participants
Insulin (7 h, between treatments)
Differences in insulin responses (from 7-hour meal challenge test) between dietary treatments during whole day for all participants
Glucose (7 h, within treatments)
Differences in glucose responses (from 7-hour meal challenge test) across strata within the same dietary treatment
Insulin (7 h, within treatments)
Differences insulin responses (from 7-hour meal challenge test) across strata within the same dietary treatment
Other outcomes
Metabolomics
Differences in metabolomics from 7-hour meal challenge test between dietary treatments for all participants
GLP-1
Differences in GLP1 from 7-hour meal challenge test between dietary treatments for all participants
GIP
Differences in GIP from 7-hour meal challenge test between dietary treatments for all participants
Anthropometry
Differences in anthropometric measures between dietary treatments for all participants
Sponsors and contacts
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Chalmers University of Technology
Lead sponsor
Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy
Collaborator
Göteborg University
Collaborator