Personalized Metabolic Responses to Rapid, Slow and Resistant Starch

NCT06897241 | Recruiting

• 1 other identifier: PerStarch
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Adults With Overweight and Obesity

Keywords

Glucose metabolism; Prevotella; AMY1 copy number; Continuous glucose monitoring; Meal tolerance test; Fecal redox potential; Home sampling

Outcome Measures

Primary Outcomes (1)

• Propionate

  Differences in plasma propionate between strata at timepoint +360 min

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

Secondary Outcomes (15)

• Glucose (7 h, between treatments)

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

• Insulin (7 h, between treatments)

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

• Glucose (7 h, within treatments)

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

• Insulin (7 h, within treatments)

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

• Glucose (4 h, breakfast, between treatments)

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

Other Outcomes (11)

• Metabolomics

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

• GLP-1

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

• GIP

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

Study Arms (3)

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

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

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

Other: Resistant starch; Other: Slow digestible starch; Other: Rapid digestible starch

Interventions

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

Rapid digestible starch; Resistant starch; Slow digestible starch

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; Resistant starch; Slow 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

Rapid digestible starch; Resistant starch; Slow digestible starch

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ability to deal with the monitoring devices
• Medications stable for the previous 14 days
• Signed informed consent

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Chalmers University of Technology: lead
• Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy: collaborator
• Göteborg University: collaborator

Study Sites (1)

Clinical Trial Center, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 413 46, Sweden

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Resistant Starch

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Rikard Landberg

  Chalmers University of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Hjort

CONTACT

0046317722848; anna.hjort@chalmers.se

Rikard Landberg

CONTACT

0046317722732; rikard.landberg@chalmers.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three-way cross-over design, where subjects are randomized to the order of the three different interventions

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: April 8, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

SE (1)