Dysbiosis
Conditions
Keywords
fiber, gut, microbiome, pulses, chickpea, lentil, young adults, transit time, prebiotic, metagenomic, metabolic health
Brief summary
The primary goal of this research is to evaluate the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on gut health, including microbiome-metabolome arrays and gut epithelial/barrier function, in healthy young adults. Secondary Objectives include: * To examine the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on the measures of metabolic health and inflammation in healthy young adults. * To determine the feasibility of healthy young adults to successfully incorporate and sustain the recommended daily intake of pulses into their diets for eight consecutive weeks Research Interventions: Participants will be asked to consume a normal diet supplemented daily with either A) whole-cooked canned lentils, or B) whole-cooked canned chickpeas. The control condition will be instructed to consume a normal diet while restricting all pulse intake throughout the study.
Interventions
OTHERGoya Foods - Canned Chickpeas
Whole-cooked, canned chickpeas supplied by Goya Foods. Provided to participants on a weekly basis in amounts specific to DGAs 2020-2025 and the participant's gender.
OTHERGoya Foods - Canned Lentils
Whole-cooked, canned lentils supplied by Goya Foods. Provided to participants on a weekly basis in amounts specific to DGAs 2020-2025 and the participant's gender.
OTHERControl
Participants in the Control condition (CTL) will be asked to consume their standard diet while avoiding any and all pulse intake.
Sponsors
Florida State University
United States Department of Agriculture (USDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 30 years old * Ability to speak and read in English
Exclusion criteria
* Intake of antibiotics in the last 3 months * Intake of pre/pro/postbiotics in the last 3 months * Current or past (within the last 6 months) user of tobacco, marijuana, or E-cigarette products * Cardiovascular disease (heart failure, hypertension, hyper/dyslipidemia, past myocardial infarction) * Gastrointestinal disease (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, fistulas, suspected or known gastric strictures, gastritis, radiation enteritis, GI bleeding, gastric bezoar, recent GI surgery in the last 3 months, etc..), * Neurological disorders (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled or insulin dependent diabetes - A1C \> 9%). * Food allergy to study foods (pulses or soy, milk, peanuts, tree nuts) * Regular consumption of pulses (\>1 cup/wk for males; \>0.5 cup/wk for females) * Current heavy alcohol use (≥ 15 drinks / week for men, ≥ 8 drinks / week for women) * Class 3 Obesity (BMI \> 40 kg/m2) * Known to be currently pregnant (self-disclosed).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gut Microbiome Diversity | Baseline (day 0) Midpoint (week 4), and endpoint (week 8) | Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria. |
| Change in Oral Microbiome Diversity | Baseline (day 0), endpoint (week 8) | Collected oral swab samples will be used to determine oral diversity and composition of bacteria in the mouth before and after intervention. |
| Change in Fecal Metabolome | Baseline (day 0) and Endpoint (week 8) | The endpoint of fecal metabolomics will be assessed by collecting fecal samples from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the feces. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health. |
| Change in Serum Metabolome | Baseline (day 0), and Endpoint (week 8). | The endpoint of serum metabolomics will be assessed by collecting blood serum from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the serum. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gut Transit Time | Baseline (day 0), Endpoint (week 8) | Evaluate changes in gut transit time (measured in minutes) after chickpea, lentil or control conditions from baseline to final analysis, using a blue-dye capsule. |
| Change in Waist / Hip Circumference | Baseline (day 0), midpoint (week 4), endpoint (week 8). | Evaluate changes in waist and hip circumference (centimeters), as well as waist-hip ratio at each study visit before, after and during chickpea, lentil and control conditions. |
| Change in Lean Mass | Baseline (day 0), midpoint (week 4), endpoint (week 8). | Evaluate changes in lean mass (kg). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during experimental (chickpea and lentil) and control conditions. |
| Change in Habitual Dietary Intake | Baseline (day 0), midpoint (week 4), endpoint (week 8). | Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software (NDSR). |
| Change in Body Weight | Baseline (day 0), midpoint (week 4), endpoint (week 8). | The endpoint of body weight (kg) will be measured at each visit to assess changes in weight before, during and after experimental and control conditions. |
| Change in Lipid Profiles | Baseline (day 0), endpoint (week 8) | Relevant biomarkers are to be collected via venous blood samples to determine changes in cardiometabolic health including HDL, LDL, total cholesterol, and triglycerides. All will be expressed in units of mg/dL. |
| Change in Biomarkers of Inflammation | Baseline (day 0), Endpoint (week 8) | Relevant biomarkers are to be collected via venous blood samples to determine changes in inflammation, including but not limited to C-reactive protein (CRP), IL-1 (Interleukin-1), IL-1 beta, IL-6, IL-10, IL-17, IL-23, Tumor Necrosis Factor Alpha (TNF-a), Interferon-gamma (IFN-Y). All will be expressed in units of pg/mL. |
| Change in Biomarkers of Intestinal Barrier Function | Baseline (day 0), endpoint (week 8). | Relevant biomarkers are to be collected via venous blood samples to determine changes in intestinal barrier function including LPS (lipopolysaccharides), LBP (lipopolysaccharide binding protein), CD14, Secretory IgA. All will be expressed in units of pg/mL. |
| Change in Biomarkers of Appetite | Baseline (day 0), endpoint (week 8) | Relevant biomarkers are to be collected via venous blood samples to determine changes in appetite including Insulin, Glucagon, glucagon-like peptide 1 (GLP-1), Adiponectin, Leptin, Ghrelin, and Peptide YY. All will be expressed in units of pg/mL. |
| Change in Rested, Seated Blood Pressure | Baseline (day 0), midpoint (week 4), endpoint (week 8). | This outcome measure will measure changes in blood pressure taken at rest in the seated position at each visit, before during and after experimental and conrol conditions, expressed as systolic over diastolic blood pressure in units of millimeters of mercury (mmHg). |
| Change in Fasting Blood Glucose | Baseline (day 0), endpoint (week 8). | Venous blood samples will be collected to determine changes in fasting blood glucose (expressed as mg/dL). |
| Dietary Adherence | Daily, baseline through endpoint (week 8) | Assess adherence to the experimental (chickpeas and lentils) and control condition throughout the study, as determined by dietary adherence logs kept by the participants each week. Adherence is expressed as a daily percent (%) consumption of their assigned condition. |
| Change in Body Fat Percentage | Baseline (day 0), midpoint (week 4), endpoint (week 8). | Evaluate changes in body composition, including fat mass, expressed as a percentage of total weight (%). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during chickpea, lentil or control conditions. |
| Change in Total Body Water | Baseline (day 0), midpoint (week 4), endpoint (week 8). | Evaluate changes in body composition, including total body water (TBW) expressed in liters (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during chickpea, lentil or control conditions. |
| Change in Intracellular Fluid | Baseline (day 0), midpoint (week 4), endpoint (week 8). | Evaluate changes in body composition, including intracellular fluid (ICF) expressed in liters (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during chickpea, lentil or control conditions. |
| Change in Extracellular Fluid | Baseline (day 0), midpoint (week 4), endpoint (week 8). | Evaluate changes in body composition, including extracellular fluid (ECF) expressed in liters (L). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during chickpea, lentil or control conditions. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRavinder Nagpal, Ph.D.
Florida State University
Outcome results
None listed