Personalized Metabolic Responses to Rapid, Slow and Resistant Starch

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorChalmers University of Technology

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Resistant starch

    Other intervention

    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

    Other intervention

    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 intervention

    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

Treatment groups

96 Participants
are divided into 3 treatment groups
Group A: Resistant starchExperimental treatment 3 interventions
Group B: Slow digestible starchActive comparator 3 interventions
Group C: Rapid digestible starchOther 3 interventions

Trial outcomes

Primary outcomes

1

Propionate

Differences in plasma propionate between strata at timepoint +360 min

Time frame
During meal challenge day (at the beginning of each intervention)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

1

Metabolomics

Differences in metabolomics from 7-hour meal challenge test between dietary treatments for all participants

Time frame
During meal challenge day (at the beginning of each intervention)
2

GLP-1

Differences in GLP1 from 7-hour meal challenge test between dietary treatments for all participants

Time frame
During meal challenge day (at the beginning of each intervention)
3

GIP

Differences in GIP from 7-hour meal challenge test between dietary treatments for all participants

Time frame
During meal challenge day (at the beginning of each intervention)
4

Anthropometry

Differences in anthropometric measures between dietary treatments for all participants

Time frame
During each intervention (14 days)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chalmers University of Technology

Lead sponsor

Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy

Collaborator

Göteborg University

Collaborator