Pulse Biomarker Discovery

Body Weight Clinical Trial

Official title:

Identifying the Role of Pulses in a Healthful Diet: Metabolomic Signatures of Dietary Pulses and Their Benefits on Cardiometabolic Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04887584
• Other study ID #: FL115
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: November 7, 2023

Study information

• Verified date: November 2023
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dietary pulses, including beans, chickpeas, and lentils, are high in soluble fiber with potential benefits to human health: Pulses are moderate energy density foods, low in fat and high in dietary protein, fiber, vitamins and minerals. Moderate pulse consumption is associated with improvements in glycemic control and reduced risk of cardiovascular disease, obesity and type 2 diabetes. Measuring pulse consumption in humans is difficult, due to limitations in current methods for dietary assessment which are largely based on dietary recalls that are subject to reporting bias. Robust tools for pulse intake assessment are needed, and biomarkers of dietary pulse intake are one approach to solve this problem. The goal of this human feeding study is evaluate the presence of biomarkers of dietary pulses in human subjects.

Description:

Dietary pulses, including beans, chickpeas, and lentils, are high in soluble fiber with potential benefits to human health: Pulses are moderate energy density foods, low in fat and high in dietary protein, fiber, vitamins and minerals. Moderate pulse consumption is associated with improvements in glycemic control and reduced risk of cardiovascular disease, obesity and type 2 diabetes. However, only 5% of the U.S. population currently meet recommended fiber intakes. As pulses are an excellent source of fiber, increasing their levels in the American diet could lead to demonstrable health benefits in the population, including positive influences on glucose regulation. Additionally, pulse impacts on the gut microbiome may be responsible for reported health benefits. While diet has direct impacts on health, these effects can be mediated by the microbiome, and dietary fiber is a key determinant of this interaction. The fermentation of soluble fiber by specific microbial species lead to the production of short chain fatty acids (SCFAs) including propionate and butyrate which are positively associated with insulin sensitivity. In general, elevated colonic SCFA production is associated with improved glucose regulation, appetite modulation, and immune system modulation.

The overall goal of this research is to evaluate how pulse digestion and microbial fermentation influence the circulating and excreted metabolome. To achieve this goal, a randomized controlled feeding study including one week of control, low pulse and high pulse diet will be provided to participants. Metabolomics will be used to identify biomarkers or signatures for pulse enriched diets in urine and plasma. In addition, researchers will investigate dietary pulse related changes in the microbiome community and short chain fatty acid production in fecal samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 7, 2023
• Est. primary completion date: November 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) 18-30 kg/m2

• Willingness to provide urine and stool and have blood drawn

Exclusion Criteria:

• Active participation in another research study

• Tested positive for severe acute respiratory syndrome (SARS) Coronavirus (COV)-2 within the past 10 days

• Been in close contact with a SARS COV-2 positive person within the past 14 days

• Unwillingness to consume pulses or pulse-related products

• Fasting glucose =120 mg/dL

• Fasting triglyceride =400 mg/dL

• LDL-cholesterol =160 mg/dL

• Blood Pressure (BP): Systolic BP =140 mmHg or Diastolic BP =90 mmHg

• Current use of dietary supplements and/or unwillingness to cease intake of dietary supplements

• Vegan or vegetarian lifestyle or any other dietary restrictions that would interfere with consuming the intervention foods and beverages (including dietary intolerances, allergies and sensitivities)

• Unwillingness to consume intervention foods and beverages

• Engage in

• More than moderate drinking (> 1 drink serving per day for women or >2 drink servings per day for men).

• Binge drinking (4 drinks within two hours).

• Excessive intake of caffeine containing products (excessive defined as = 400mg/day)

• Diagnosis of disordered eating or eating disorder

• Recent diagnosis of any of the following or measurement on screening lab tests

• Anemia (hemoglobin <11.7g/dL)

• Abnormal liver function

• Liver Enzymes that are >200% of upper limit (alanine aminotransferase (ALT) upper limit is 43 U/L or aspartate aminotransferase (AST) upper limit is 54 U/L)

• History of any of the following

• Gastric bypass surgery

• Inflammatory bowel disease (IBD) or other GI conditions that would interfere with consuming the intervention foods

• Active cancer in the past three years excluding squamous or basal cell carcinomas of the skin that have been handled medically by local excision

• Other serious medical conditions

• Recent dental work or have conditions of the oral cavity that would interfere with consuming the intervention foods and beverages

• Long term use of antibiotics

• Taking any over the counter or prescribed medication for any of the following

• Elevated lipids or glucose

• High blood pressure

• Weight loss

• Are pregnant, planning to become pregnant within the duration of the study or breastfeeding.

Related Conditions & MeSH terms

• Body Weight

Intervention

Other:
• Control diet
The control Typical American Diet (TAD) diet pattern will mimic the level of intake of fruits, vegetables, whole grains, added sugars, saturated fats and sodium in the general U.S. population. This diet will feature no servings of pulses per day.
• Low Pulse diet
The Low Pulse diet will be designed based on the TAD with substitution of pulses for lean meat and grains. This diet will feature 0.2 cups of pulses per day at 2,000 kilocalories (kcals).
• High Pulse diet
The High Pulse diet will be designed based on the TAD with substitution of pulses for lean meat and grains. This diet will feature 1.5 cups of pulses per day at 2,000 kilocalories (kcals).

Locations

Country	Name	City	State
United States	USDA ARS Western Human Nutrition Research Center	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (20)

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Madrid-Gambin F, Llorach R, Vazquez-Fresno R, Urpi-Sarda M, Almanza-Aguilera E, Garcia-Aloy M, Estruch R, Corella D, Andres-Lacueva C. Urinary 1H Nuclear Magnetic Resonance Metabolomic Fingerprinting Reveals Biomarkers of Pulse Consumption Related to Energy-Metabolism Modulation in a Subcohort from the PREDIMED study. J Proteome Res. 2017 Apr 7;16(4):1483-1491. doi: 10.1021/acs.jproteome.6b00860. Epub 2017 Mar 16. — View Citation

Makki K, Deehan EC, Walter J, Backhed F. The Impact of Dietary Fiber on Gut Microbiota in Host Health and Disease. Cell Host Microbe. 2018 Jun 13;23(6):705-715. doi: 10.1016/j.chom.2018.05.012. — View Citation

Margier M, George S, Hafnaoui N, Remond D, Nowicki M, Du Chaffaut L, Amiot MJ, Reboul E. Nutritional Composition and Bioactive Content of Legumes: Characterization of Pulses Frequently Consumed in France and Effect of the Cooking Method. Nutrients. 2018 Nov 4;10(11):1668. doi: 10.3390/nu10111668. — View Citation

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McRorie JW Jr, McKeown NM. Understanding the Physics of Functional Fibers in the Gastrointestinal Tract: An Evidence-Based Approach to Resolving Enduring Misconceptions about Insoluble and Soluble Fiber. J Acad Nutr Diet. 2017 Feb;117(2):251-264. doi: 10.1016/j.jand.2016.09.021. Epub 2016 Nov 15. — View Citation

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Muller M, Hernandez MAG, Goossens GH, Reijnders D, Holst JJ, Jocken JWE, van Eijk H, Canfora EE, Blaak EE. Circulating but not faecal short-chain fatty acids are related to insulin sensitivity, lipolysis and GLP-1 concentrations in humans. Sci Rep. 2019 Aug 29;9(1):12515. doi: 10.1038/s41598-019-48775-0. — View Citation

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Wrzosek L, Miquel S, Noordine ML, Bouet S, Joncquel Chevalier-Curt M, Robert V, Philippe C, Bridonneau C, Cherbuy C, Robbe-Masselot C, Langella P, Thomas M. Bacteroides thetaiotaomicron and Faecalibacterium prausnitzii influence the production of mucus glycans and the development of goblet cells in the colonic epithelium of a gnotobiotic model rodent. BMC Biol. 2013 May 21;11:61. doi: 10.1186/1741-7007-11-61. — View Citation

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urine metabolomics profile	Urine metabolites will be measured by gas chromatography mass spectrometry (GCMS) before and after consumption of control, low pulse or high pulse diets.	Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr, 6hr, 12hr and 24hr
Primary	Change in plasma metabolomics profile	Plasma metabolites will be measured by gas chromatography mass spectrometry (GCMS) before and after consumption of control, low pulse or high pulse diets.	Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Secondary	Change in fecal microbiome community	DNA of colonic microbiome will be measured before and after each diet exposure.	Day 7, 14, 21, 28, 35, 42
Secondary	Change in fecal short chain fatty acids	Acetate, propionate and butyrate will be measured by GCMS before and after each diet exposure.	Day 7, 14, 21, 28, 35, 42
Secondary	Change in fecal bile acids	Bile acids will be measured by GCMS before and after each diet exposure.	Day 7, 14, 21, 28, 35, 42
Secondary	Change in plasma short-chain fatty acids	Plasma acetate, propionate and butyrate will be measured by GCMS before and after consumption of control, low pulse or high pulse diets.	Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Secondary	Change in pro-inflammatory cytokines	Cytokines including tumor necrosis factor alpha (TNF-a), interleukin (IL)-1, IL-6 and interferon-gamma will be measured in plasma using multiplex assays.	Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Secondary	Change in anti-inflammatory cytokines	Cytokines including interleukin (IL)-1 receptor antagonist, IL-4, IL-10, IL-11, and IL-13 will be measured in plasma using multiplex assays.	Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr