Gastrointestinal Assessment of Three Novel RS4

NCT03255603 | Completed

• 1 other identifier: Pro00069884
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The rates of chronic diseases like obesity, diabetes, and heart disease are rising across the world. This is especially true in industrialized countries like Canada and the USA. Even though there are many possible causes for these increases. One prominent cause is our refined diet, which greatly lacks dietary fiber. This 'fiber gap' between the amount of fiber actually eaten and the amount that should be eaten is likely promoting these diseases. It is known that a high fiber diet can benefit health and the health of the gut bacteria. It is also know that these gut microbes can help cause and prevent diseases. When fiber is eaten, it gets broken down not by us, but by our gut microbes. During this process by-products called short-chain fatty acids (SCFA) are made. These SCFA have been shown to promote health. Therefore, it is thought that fiber changes the gut microbes to produce more SCFA, which may improve overall health. In order to aid our microbes and improve our health we need to find ways to reduce this 'fiber gap'. One possibility is to add fiber to our refined diet. To do so we must first learn how different fibers perform in our gut. This includes how our gut tolerates increasing amounts of fiber, and how our microbes respond. The purpose of this study is to learn how different types of resistant starch perform in our gut, including gastrointestinal tolerance. By doing so we will determine the ideal dose and type of these fibers to use in future studies.

Conditions

Diet Modification

Keywords

Resistant Starch; Dietary Fiber; Gastrointestinal Microbiome; Gastrointestinal Tolerance

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Tolerance

  Gastrointestinal tolerance will be assessed at weeks 0-4 of fiber intervention with a weekly gastrointestinal tolerability questionnaire.

  4-week period

Secondary Outcomes (3)

• Gastrointestinal Habits

  4-week period

• Gastrointestinal Microbiome Composition

  4-week period

• Gastrointestinal Microbiome Function

  4-week period

Study Arms (4)

Modified potato starch

EXPERIMENTAL

Modified potato starch is a resistant starch type IV and will be used as an experimental arm.

Other: Resistant Starch Type 4 Supplementation

Modified corn starch

EXPERIMENTAL

Modified corn starch is a resistant starch type IV and will be used as an experimental arm.

Other: Resistant Starch Type 4 Supplementation

Modified tapioca starch

EXPERIMENTAL

Modified tapioca starch is a resistant starch type IV and will be used as an experimental arm.

Other: Resistant Starch Type 4 Supplementation

Corn starch

PLACEBO COMPARATOR

Corn starch is digestible and will therefore will be used as a placebo control for the study.

Other: Digestible Starch Supplementation

Interventions

Resistant Starch Type 4 Supplementation OTHER

Ten participants will supplement their normal dietary intake with RS4 daily for four consecutive weeks, with each week the amount of RS4 provided being increased (10 g, 20 g, 35 g and 50 g/day).

Also known as: Modified potato starch

Modified potato starch

Digestible Starch Supplementation OTHER

Ten participants will supplement their normal dietary intake with digestible starch daily for four consecutive weeks, with each week the amount of starch provided being increased.

Also known as: Corn starch

Corn starch

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• men and pre-menopausal, non-pregnant or non-lactating women
• non-vegetarian
• non-smoking
• alcohol intake ≤8 drinks/week
• ≤5 h/week of moderate-vigorous exercise

You may not qualify if:

• acute or chronic GI illnesses, conditions, or issues
• history of GI surgical intervention
• chronic or current use of anti-hypertensive, lipid-lowering, anti-diabetic, analgesic, or laxative medications
• antibiotic treatment in the last 3 months
• use of fiber or probiotics supplements
• allergies or intolerances to fiber sources

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Alberta Diabetes Institute Clinical Research Unit

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Interventions

octenyl succinic anhydride-modified starch; Starch

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Jens Walter, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 21, 2017
• Study Start: September 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: December 22, 2018
• Last Updated: September 19, 2024

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)