Resistant Starch Wheat for Improved Metabolic Health

NCT03082131 | Completed

• 1 other identifier: 984621-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the effect of wheat enriched in resistant starch (RS) on the generation of fermentation products by the lower gut microbes, the fecal microbiota profile, intestinal metabolites, and the glycemic response to a test meal compared to regular wheat.

Conditions

Gut Microbiota; Metabolism; Metabolic Health

Keywords

Gut Microbiota; Glycemic Response; Resistant Starch; Fiber

Outcome Measures

Primary Outcomes (1)

• Changes in Gut Microbiota Composition

  Gut microbiota community composition will be determined by 16S ribosomal ribonucleic acid (rRNA) gene sequencing from stool samples

  Days 1, 7, 22, and 29

Secondary Outcomes (5)

• Changes in Glucose Metabolism

  0, 1, 2, and 3 hours postprandial

• Changes in Gut Microbiota Metabolism

  0, 0.5, 1, 1.5, 2, 2.5, 3 hours postprandial

• Changes in Gut Microbiota Metabolism

  0, 1, 2, and 3 hours postprandial

• Evaluation of Consumer Acceptance

  Days 8 and 30

• Dietary Intake

  Days 3, 5, 8, 25, 27, and 30

Study Arms (2)

Group 1

EXPERIMENTAL

Order of treatments: A. Resistant Starch Wheat B. Regular Wheat

Dietary Supplement: Resistant Starch Wheat

Group 2

EXPERIMENTAL

Order of treatments: A. Regular Wheat B. Resistant Starch Wheat

Dietary Supplement: Resistant Starch Wheat

Interventions

Resistant Starch Wheat DIETARY_SUPPLEMENT

The investigators will be testing high amylose wheat varieties developed by Arcadia Biosciences that have high levels of RS in the endosperm, the source of refined flour. Compared to regular wheat varieties with RS levels of less than 1%, Arcadia's wheat varieties contain between 16% and 34% RS.

Group 1; Group 2

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults. Healthy means that the candidate reports that s/he feels well and can perform normal activities.

You may not qualify if:

• BMI \<18.5 and \>39.9 kg/m2
• Presence of of untreated or uncontrolled metabolic diseases
• Presence of gastrointestinal disorders that could interfere with the study outcome (i.e. Crohn's disease, Irritable bowel syndrome, Colitis)
• Use of oral antibiotics within the past 3 months
• Presence of cancer or other serious chronic disease by self report
• Current use of prescribed or over the counter weight loss medications
• Pregnant
• Lactating
• Current use of tobacco
• Dietary restrictions that would interfere with consuming the intervention foods

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead
• University of California, Davis: collaborator

Study Sites (1)

Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will be blinded to the type of product (i.e. RS wheat or Regular Wheat) the subjects are consuming during each arm of the study.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized, cross-over design consisting of two 1-week dietary intervention periods as well as a 2-week washout period in between

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 17, 2017
• Study Start: May 22, 2017
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)