The Role of Dietary Intake and Host Genetics in Gut Microbiome Response to Resistant Starch Consumption

Resistant starch (RS), a type of dietary fiber, was shown to have beneficial effects on human health through its impact on microbes present in the intestine. However, the effects of RS on the gut microbiota and in turn, on human health, can vary between individuals. Consequently, everyone may not reap the same health benefits by eating high amounts of RS. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes respond to RS supplementation would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber intake. The objective of this study was to evaluate candidate predictors of gut microbiota response to RS supplementation.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: RS2-control-RS4; Dietary supplement: RS4-control-RS2

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Ithaca, New York, United States, 14853
      • Cornell University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Above 18 years of age
• Willing to consume the supplements provided throughout the duration of the study

Exclusion Criteria:

• History of diabetes, prediabetes or impaired glucose tolerance.
• Existing, UNTREATED, thyroid condition.
• Usage of systemic antibiotics (intravenous injection, intramuscular, or oral) within 6 months prior to the study.
• Acute disease at the time of enrollment.
• Chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality.

• History of active UNTREATED gastrointestinal disorders or diseases including:

  i. Inflammatory bowel disease (IBD) ii. Ulcerative colitis (mild-moderate-severe) iii. Crohn's disease (mild- moderate-severe) iv. Indeterminate colitis v. Irritable bowel syndrome (IBS) (moderate-severe) vi. Persistent, infectious gastroenteritis, colitis or gastritis vii. Persistent or chronic diarrhea of unknown etiology viii. Clostridium difficile infection (recurrent) ix. Chronic constipation

• Suspected state of immunosuppression or immunodeficiency including HIV.
• History of bariatric surgery.
• Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: RS2 first; Crackers were provided during each of 3 treatment periods in a crossover design. The 3 types of crackers were matched for total carbohydrate content. Treatment period 1 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 2 (30g/day) for 7 days; Treatment period 2 (10 days): Participants received control crackers with 100% digestible starch; Treatment period 3 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 4 (30g/day) for 7 days. There were 5-day washout periods between the treatment periods.	Dietary supplement: RS2-control-RS4; Group A: Treatment 1 = RS2 (Hi-Maize 260), Treatment 2 = Control (Amioca TF), Treatment 3 = RS4 (Versafibe 1490)
Experimental: Group B: RS4 first; Crackers were provided during each of 3 treatment periods in a crossover design. The 3 types of crackers were matched for total carbohydrate content. Treatment period 1 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 4 (30g/day) for 7 days; Treatment period 2 (10 days): Participants received control crackers with 100% digestible starch; Treatment period 3 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 2 (30g/day) for 7 days. There were 5-day washout periods between the treatment periods.	Dietary supplement: RS4-control-RS2; Group B: Treatment 1 = RS4 (Versafibe 1490), Treatment 2 = Control (Amioca TF), Treatment 3 = RS2 (Hi-Maize 260)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome	16S rRNA gene survey of gut microbial communities	7 weeks
Fecal short-chain fatty acid concentration	Fecal short-chain fatty acid concentration measurements with ultra-performance liquid chromatography	7 weeks

Collaborators and Investigators

• Sponsor: Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1902008575

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No