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Trial record 6 of 93 for:    Recruiting, Not yet recruiting, Available Studies | "Cholesterol"

Corn and Heart Health Study (CHS)

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ClinicalTrials.gov Identifier: NCT03967990
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
North American Millers Association - Corn Division
Information provided by (Responsible Party):
Arizona State University

Brief Summary:
The purpose of this study is to investigate the effects of 3 different corn flours: (1) whole grain corn flour, (2) 50% refined corn flour + 50% corn bran derived from whole corn meal, and (3) refined corn flour, on cardio-metabolic outcomes and changes in the gut microbiome.

Condition or disease Intervention/treatment Phase
Gut Microbiome Cholesterol, LDL Cholesterol, HDL Other: Refined cornmeal flour Other: 50/50 refined cornmeal-bran mix Other: Whole grain cornmeal flour Not Applicable

Detailed Description:

Dietary fibers are extremely complex and foster health in a variety of ways that are not fully understood. The Adequate Intake of fiber (14 g per 1000 kcal consumed) is based on data that strongly support a relationship with cardiovascular disease prevention (Slavin, 2013). While cereal fibers have been shown to be most effective at reducing cardiovascular disease risk (IOM, 2002), the components of dietary fiber (e.g. germ, bran) that exert this effect remain inadequately studied in cardiometabolic outcomes. Further, specific types of dietary fiber (natural and synthetic) have been shown to increase beneficial microbial species in the gastrointestinal tract, which are accompanied by improvements in inflammatory and metabolic disease markers. Very little is known about how isolated or intact fiber in whole grains solicit beneficial health effects via microbial mechanisms. Our goal is to study both changes in cardiometabolic outcomes and the gut microbiome after consuming different types of corn-based meals.

Aim 1: To evaluate cardio-metabolic outcomes (primary outcome: LDL cholesterol) after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design.

Aim 2: To evaluate changes in the gut microbiome after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluating the Effects of Corn Flour Consumption on Cardio-metabolic Outcomes and the Gut Microbiome in Adults With High Cholesterol
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: refined-50/50-whole
48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) refined cornmeal flour, followed by (2) 50/50 mix of refined cornmeal flour plus corn bran, followed by (3) whole grain cornmeal flour
Other: Refined cornmeal flour
48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: 50/50 refined cornmeal-bran mix
48 g/d of a mix of 50% refined cornmeal flour and 50% corn bran flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: Whole grain cornmeal flour
48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Experimental: 50/50-whole-refined
48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) 50/50 mix of refined cornmeal flour plus corn bran, followed by (2) whole grain cornmeal flour, followed by (3) refined cornmeal flour
Other: Refined cornmeal flour
48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: 50/50 refined cornmeal-bran mix
48 g/d of a mix of 50% refined cornmeal flour and 50% corn bran flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: Whole grain cornmeal flour
48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Experimental: whole-refined-50/50
48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) whole grain cornmeal flour, followed by (2) refined cornmeal flour, followed by (3) 50/50 mix of refined cornmeal flour plus corn bran
Other: Refined cornmeal flour
48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: 50/50 refined cornmeal-bran mix
48 g/d of a mix of 50% refined cornmeal flour and 50% corn bran flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: Whole grain cornmeal flour
48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Experimental: refined-whole-50/50
48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) refined cornmeal flour, followed by (2) whole grain cornmeal flour, followed by (3) 50/50 mix of refined cornmeal flour plus corn bran
Other: Refined cornmeal flour
48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: 50/50 refined cornmeal-bran mix
48 g/d of a mix of 50% refined cornmeal flour and 50% corn bran flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: Whole grain cornmeal flour
48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Experimental: 50/50-refined-whole
48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) 50/50 mix of refined cornmeal flour plus corn bran, followed by (2) refined cornmeal flour, followed by (3) whole grain cornmeal flour
Other: Refined cornmeal flour
48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: 50/50 refined cornmeal-bran mix
48 g/d of a mix of 50% refined cornmeal flour and 50% corn bran flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: Whole grain cornmeal flour
48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Experimental: whole-50/50-refined
48 g/d of corn flour was delivered to participants in two daily 24 g servings as pita breads and/or muffins via (1) whole grain cornmeal flour, followed by (2) 50/50 mix of refined cornmeal flour plus corn bran, followed by (3) refined cornmeal flour
Other: Refined cornmeal flour
48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: 50/50 refined cornmeal-bran mix
48 g/d of a mix of 50% refined cornmeal flour and 50% corn bran flour served to participants as two daily 24 g servings via pita breads and/or muffins

Other: Whole grain cornmeal flour
48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins




Primary Outcome Measures :
  1. LDL Cholesterol [ Time Frame: 0 weeks, 4 weeks ]
    Serum LDL cholesterol concentrations will be measured at the 0 and 4 weeks for each cornmeal intervention

  2. HDL Cholesterol [ Time Frame: 0 weeks, 4 weeks ]
    Serum HDL cholesterol concentrations will be measured at the 0 and 4 weeks for each cornmeal intervention


Secondary Outcome Measures :
  1. Gut Microbiome Diversity [ Time Frame: 0 weeks, 4 weeks ]
    Fecal gut microbiome communities will be sequenced using microbial DNA extracted from samples at 0 and 4 weeks for each cornmeal intervention. Amplified copies of the 16S rRNA gene will be evaluated for treatment differences in alpha (within-sample richness and evenness) and beta diversity (between-sample community structure). Relative and differential abundance of individual microbial taxa will also be measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy English and Spanish speaking males and females with elevated circulating cholesterol levels (LDL-c ≥ 120 mg/dL).
  • Individuals with LDL-c > 190 mg/dL will be permitted to participate but must provide a letter from their doctor stating that they are comfortable with their participation in the study.

Exclusion Criteria:

  • recent weight fluctuations (> 5 lb in past 3 months), following specialized or restrictive diets (e.g. carbohydrate restriction, veganism)
  • use of supplements (antioxidants, fiber, botanicals)
  • allergies to dairy, egg, wheat, corn or gluten
  • use of antibiotics in the past 2-3 months
  • use of lipid lowering medications
  • regular physical activity ≥ 30 min/d for ≥ 5 days/wk
  • history of thyroid disorders, diabetes, heart disease, cancer, hepatitis, inflammatory conditions and/or gastrointestinal disorders which may impact gut function and metabolism
  • anyone with a fear of needles or blood draws
  • If female, women may not be pregnant or lactating during the study.
  • Unwillingness to comply with study protocols will also result in exclusion from the study.
  • Participants in this study will not be eligible if they are participating in other research studies at the same time.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967990


Contacts
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Contact: Corrie M Whisner, PhD 602-496-3348 cwhisner@asu.edu

Locations
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United States, Arizona
Arizona Biomedical Collaborative Recruiting
Phoenix, Arizona, United States, 85007
Contact: Corrie M Whisner, PhD    602-496-3348    cwhisner@asu.edu   
Sponsors and Collaborators
Arizona State University
North American Millers Association - Corn Division
Investigators
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Principal Investigator: Corrie M Whisner, PhD Arizona State University

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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT03967990     History of Changes
Other Study ID Numbers: STUDY00007518
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arizona State University:
cholesterol
gut microbiome
gut microbiota
dietary fiber
whole grain