Body WeightNCT04887584
Pulse Biomarker Discovery
A study testing Low Pulse diet and High Pulse diet in people with Body Weight, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- What is being tested?
- Low Pulse diet and High Pulse diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 7 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) 18-30 kg/m2
- Willingness to provide urine and stool and have blood drawn
Who cannot join
- 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
Show all 32Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA ARS Western Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Identifying the Role of Pulses in a Healthful Diet: Metabolomic Signatures of Dietary Pulses and Their Benefits on Cardiometabolic Risk Factors
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.
Read the detailed 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.
- Conditions
- Body Weight
- Being tested
- Control diet, Low Pulse diet, High Pulse diet
- Keywords
- Dietary pulses, Urine biomarkers, Microbiome, Short chain fatty acids, Plasma biomarkers, Fecal biomarkers, Beans, Lentils, Controlled feeding, Intervention, Chickpeas, Metabolomics
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control dietOther
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 dietOther
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 dietOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Order of treatments:
A: Control diet B: Low pulse diet C: High pulse diet Receives: Other: Control diet; Other: Low Pulse diet; Other: High Pulse diet |
| Group 2 | Experimental | Order of treatments:
A: Control diet C: High pulse diet B: Low pulse diet Receives: Other: Control diet; Other: Low Pulse diet; Other: High Pulse diet |
| Group 3 | Experimental | Order of treatments:
B: Low pulse diet A: Control diet C: High pulse diet Receives: Other: Control diet; Other: Low Pulse diet; Other: High Pulse diet |
| Group 4 | Experimental | Order of treatments:
B: Low pulse diet C: High pulse diet A: Control diet Receives: Other: Control diet; Other: Low Pulse diet; Other: High Pulse diet |
| Group 5 | Experimental | Order of treatments:
C: High pulse diet A: Control diet B: Low pulse diet Receives: Other: Control diet; Other: Low Pulse diet; Other: High Pulse diet |
| Group 6 | Experimental | Order of treatments:
C: High pulse diet B: Low pulse diet A: Control diet Receives: Other: Control diet; Other: Low Pulse diet; Other: High Pulse diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr, 6hr, 12hr and 24hr
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.
Measured: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Secondary outcomes (6)
Change in fecal microbiome community
DNA of colonic microbiome will be measured before and after each diet exposure.
Measured: Day 7, 14, 21, 28, 35, 42
Change in fecal short chain fatty acids
Acetate, propionate and butyrate will be measured by GCMS before and after each diet exposure.
Measured: Day 7, 14, 21, 28, 35, 42
Change in fecal bile acids
Bile acids will be measured by GCMS before and after each diet exposure.
Measured: Day 7, 14, 21, 28, 35, 42
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.
Measured: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
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.
Measured: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
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.
Measured: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 May 2022
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Brian J Bennett, PhD, Principal investigator, USDA ARS Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887584
- Sponsor's protocol ID
- FL115
- Status last verified
- Oct 2024
- First submitted
- 10 May 2021
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCrory MA, Hamaker BR, Lovejoy JC, Eichelsdoerfer PE. Pulse consumption, satiety, and weight management. Adv Nutr. 2010 Nov;1(1):17-30. doi: 10.3945/an.110.1006. Epub 2010 Nov 16.
PubMed 22043448Margier 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.
PubMed 30400385Mudryj AN, Yu N, Aukema HM. Nutritional and health benefits of pulses. Appl Physiol Nutr Metab. 2014 Nov;39(11):1197-204. doi: 10.1139/apnm-2013-0557. Epub 2014 Jun 13.
PubMed 25061763Jenkins DJ, Kendall CW, Augustin LS, Mitchell S, Sahye-Pudaruth S, Blanco Mejia S, Chiavaroli L, Mirrahimi A, Ireland C, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Leiter LA, Josse RG. Effect of legumes as part of a low glycemic index diet on glycemic control and cardiovascular risk factors in type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2012 Nov 26;172(21):1653-60. doi: 10.1001/2013.jamainternmed.70.
PubMed 23089999Anderson JW, Baird P, Davis RH Jr, Ferreri S, Knudtson M, Koraym A, Waters V, Williams CL. Health benefits of dietary fiber. Nutr Rev. 2009 Apr;67(4):188-205. doi: 10.1111/j.1753-4887.2009.00189.x.
PubMed 19335713Threapleton DE, Greenwood DC, Evans CE, Cleghorn CL, Nykjaer C, Woodhead C, Cade JE, Gale CP, Burley VJ. Dietary fibre intake and risk of cardiovascular disease: systematic review and meta-analysis. BMJ. 2013 Dec 19;347:f6879. doi: 10.1136/bmj.f6879.
PubMed 24355537Yao B, Fang H, Xu W, Yan Y, Xu H, Liu Y, Mo M, Zhang H, Zhao Y. Dietary fiber intake and risk of type 2 diabetes: a dose-response analysis of prospective studies. Eur J Epidemiol. 2014 Feb;29(2):79-88. doi: 10.1007/s10654-013-9876-x. Epub 2014 Jan 5.
PubMed 24389767Quagliani D, Felt-Gunderson P. Closing America's Fiber Intake Gap: Communication Strategies From a Food and Fiber Summit. Am J Lifestyle Med. 2016 Jul 7;11(1):80-85. doi: 10.1177/1559827615588079. eCollection 2017 Jan-Feb.
PubMed 30202317Makki 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.
PubMed 29902436Muller 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.
PubMed 31467327Wrzosek 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.
PubMed 23692866McRorie 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.
PubMed 27863994Parada Venegas D, De la Fuente MK, Landskron G, Gonzalez MJ, Quera R, Dijkstra G, Harmsen HJM, Faber KN, Hermoso MA. Short Chain Fatty Acids (SCFAs)-Mediated Gut Epithelial and Immune Regulation and Its Relevance for Inflammatory Bowel Diseases. Front Immunol. 2019 Mar 11;10:277. doi: 10.3389/fimmu.2019.00277. eCollection 2019.
PubMed 30915065Garcia-Mantrana I, Selma-Royo M, Alcantara C, Collado MC. Shifts on Gut Microbiota Associated to Mediterranean Diet Adherence and Specific Dietary Intakes on General Adult Population. Front Microbiol. 2018 May 7;9:890. doi: 10.3389/fmicb.2018.00890. eCollection 2018.
PubMed 29867803Gibson RS, Charrondiere UR, Bell W. Measurement Errors in Dietary Assessment Using Self-Reported 24-Hour Recalls in Low-Income Countries and Strategies for Their Prevention. Adv Nutr. 2017 Nov 15;8(6):980-991. doi: 10.3945/an.117.016980. Print 2017 Nov.
PubMed 29141979
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Role of Pulses in a Healthful Diet: Metabolomic Signatures of Dietary Pulses and Their Benefits on Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT04887584
- Acronym / sponsor ID
- FL115
- Conditions
- Body Weight
- Keywords
- Dietary pulses, Urine biomarkers, Microbiome, Short chain fatty acids, Plasma biomarkers, Fecal biomarkers, Beans, Lentils
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- University of California, Davis
- Study start
- 1 May 2022 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Control diet, Other: Low Pulse diet, Other: High Pulse dietOrder of treatments: A: Control diet B: Low pulse diet C: High pulse diet |
| Group 2 | Experimental | Other: Control diet, Other: Low Pulse diet, Other: High Pulse dietOrder of treatments: A: Control diet C: High pulse diet B: Low pulse diet |
| Group 3 | Experimental | Other: Control diet, Other: Low Pulse diet, Other: High Pulse dietOrder of treatments: B: Low pulse diet A: Control diet C: High pulse diet |
| Group 4 | Experimental | Other: Control diet, Other: Low Pulse diet, Other: High Pulse dietOrder of treatments: B: Low pulse diet C: High pulse diet A: Control diet |
| Group 5 | Experimental | Other: Control diet, Other: Low Pulse diet, Other: High Pulse dietOrder of treatments: C: High pulse diet A: Control diet B: Low pulse diet |
| Group 6 | Experimental | Other: Control diet, Other: Low Pulse diet, Other: High Pulse dietOrder of treatments: C: High pulse diet B: Low pulse diet A: Control diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) 18-30 kg/m2
- Willingness to provide urine and stool and have blood drawn
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control dietThe 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. | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| Low Pulse dietThe 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). | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| High Pulse dietThe 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). | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Change in urine metabolomics profile
Time frame: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr, 6hr, 12hr and 24hr
Urine metabolites will be measured by gas chromatography mass spectrometry (GCMS) before and after consumption of control, low pulse or high pulse diets.
Change in plasma metabolomics profile
Time frame: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Plasma metabolites will be measured by gas chromatography mass spectrometry (GCMS) before and after consumption of control, low pulse or high pulse diets.
6 secondary outcomes
Change in fecal microbiome community
Time frame: Day 7, 14, 21, 28, 35, 42
Change in fecal short chain fatty acids
Time frame: Day 7, 14, 21, 28, 35, 42
Change in fecal bile acids
Time frame: Day 7, 14, 21, 28, 35, 42
Change in plasma short-chain fatty acids
Time frame: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Change in pro-inflammatory cytokines
Time frame: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Change in anti-inflammatory cytokines
Time frame: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr and 6hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Background: PubMed 22043448McCrory MA, Hamaker BR, Lovejoy JC, Eichelsdoerfer PE. Pulse consumption, satiety, and weight management. Adv Nutr. 2010 Nov;1(1):17-30. doi: 10.3945/an.110.1006. Epub 2010 Nov 16.
- Background: PubMed 30400385Margier 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.
- Background: PubMed 25061763Mudryj AN, Yu N, Aukema HM. Nutritional and health benefits of pulses. Appl Physiol Nutr Metab. 2014 Nov;39(11):1197-204. doi: 10.1139/apnm-2013-0557. Epub 2014 Jun 13.
- Background: PubMed 23089999Jenkins DJ, Kendall CW, Augustin LS, Mitchell S, Sahye-Pudaruth S, Blanco Mejia S, Chiavaroli L, Mirrahimi A, Ireland C, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Leiter LA, Josse RG. Effect of legumes as part of a low glycemic index diet on glycemic control and cardiovascular risk factors in type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2012 Nov 26;172(21):1653-60. doi: 10.1001/2013.jamainternmed.70.
- Background: PubMed 19335713Anderson JW, Baird P, Davis RH Jr, Ferreri S, Knudtson M, Koraym A, Waters V, Williams CL. Health benefits of dietary fiber. Nutr Rev. 2009 Apr;67(4):188-205. doi: 10.1111/j.1753-4887.2009.00189.x.
- Background: PubMed 24355537Threapleton DE, Greenwood DC, Evans CE, Cleghorn CL, Nykjaer C, Woodhead C, Cade JE, Gale CP, Burley VJ. Dietary fibre intake and risk of cardiovascular disease: systematic review and meta-analysis. BMJ. 2013 Dec 19;347:f6879. doi: 10.1136/bmj.f6879.
- Background: PubMed 24389767Yao B, Fang H, Xu W, Yan Y, Xu H, Liu Y, Mo M, Zhang H, Zhao Y. Dietary fiber intake and risk of type 2 diabetes: a dose-response analysis of prospective studies. Eur J Epidemiol. 2014 Feb;29(2):79-88. doi: 10.1007/s10654-013-9876-x. Epub 2014 Jan 5.
- Background: PubMed 30202317Quagliani D, Felt-Gunderson P. Closing America's Fiber Intake Gap: Communication Strategies From a Food and Fiber Summit. Am J Lifestyle Med. 2016 Jul 7;11(1):80-85. doi: 10.1177/1559827615588079. eCollection 2017 Jan-Feb.
- Background: PubMed 29902436Makki 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.
- Background: PubMed 31467327Muller 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.
- Background: PubMed 23692866Wrzosek 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.
- Background: PubMed 27863994McRorie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian J Bennett, PhD principal investigator
USDA ARS Western Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Pulse diet and High Pulse diet in people with Body Weight, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urine metabolomics profile (time frame: Day 14, 28, and 42; fasting and post prandial 0.5hr, 2hr, 3hr, 6hr, 12hr and 24hr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04887584, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.