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Completed

NCT Number: NCT03082131

Resistant Starch Wheat for Improved Metabolic Health

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

Resistant starch (RS) is a type of dietary fiber that provides fermentable carbohydrate (FC) in the lower bowel yielding positive effects on postprandial glycemia and weight management as well as digestive tract health. RS is defined as the portion of starch resistant to digestion by amylases, allowing it to reach the distal intestine where it can be fermented by the resident intestinal microbiota. A limited number of human studies using RS from high amylose corn have demonstrated that RS increases synthesis of gut peptides that improve glucose homeostasis and insulin secretion. Based on these studies, the FDA has recently approved the following health claims for resistant starch derived from corn (RS2): lowering of blood glucose, blood cholesterol, and blood pressure; increased mineral absorption; improved laxation; and reduced energy intake. The purpose in the proposed "proof of concept" study here is to show that RS provided in the form of wheat flour products has similar beneficial effects. The investigators aim to further explore the effect of RS on the gut microbiota. The intestinal microbiome is comprised of over one trillion bacterial cells comprised of approximately one thousand species that perform diverse functions ranging from energy harvest, angiogenesis, immunomodulation, and regulation of mood and behavior. Some of the major products of bacterial metabolism include acetate, propionate, and butyrate, the major short chain fatty acids (SCFA). These bioactive fermentation products have been associated with improved glucose homeostasis, attributed, in part, by their interactions with receptors on intestinal cells to augment secretion of glucagon-like peptide-1 (GLP-1), an incretin hormone known to stimulate insulin secretion.

This study is a randomized, cross-over design consisting of two 1-week dietary intervention periods as well as a 2-week washout period in between. Subjects will be randomly assigned to receive either RS wheat first or regular wheat first, then will be crossed over to the opposite treatment following a 2-week washout period. Wheat products made from RS wheat and regular wheat will be provided and the volunteers will be instructed to incorporate the products into their usual diet for 7 days. This study will probe the associations between the gut microbiota profiles, fermentation of RS wheat, microbial-mediated alterations in bile acids, and glycemia. The investigators will measure these effects in healthy, middle-aged humans using an interdisciplinary approach that integrates nutrition, microbiology, intestinal physiology, and analytical chemistry.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Changes in Gut Microbiota Composition

    Time frame: Days 1, 7, 22, and 29

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

Secondary outcomes

  1. Changes in Glucose Metabolism

    Time frame: 0, 1, 2, and 3 hours postprandial

    Fasting and postprandial measures of blood glucose, insulin, GLP-1

  2. Changes in Gut Microbiota Metabolism

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3 hours postprandial

    Fasting and postprandial measures of hydrogen and methane in breath

  3. Changes in Gut Microbiota Metabolism

    Time frame: 0, 1, 2, and 3 hours postprandial

    Fasting and postprandial measures of SCFA and bile acids in plasma

  4. Evaluation of Consumer Acceptance

    Time frame: Days 8 and 30

    Participant-reported liking and taste

  5. Dietary Intake

    Time frame: Days 3, 5, 8, 25, 27, and 30

    24-hour dietary recalls

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • University of California, Davis

Registry information

Official study title

Resistant Starch Wheat for Improved Metabolic Health: A Proof of Concept Study in Human Subjects

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 17, 2017
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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