The Effect of Regular Lentil and Chickpea Intake on Gut Microbiome and Metabolic Health in Healthy Young Adults: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Gut Microbiome Diversity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 30 years old
- •Ability to speak and read in English
排除标准
- •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).
研究组 & 干预措施
Chickpea Condition
The chickpea (CHK) condition includes a normal diet supplemented weekly with whole-cooked canned chickpeas for 8 weeks (Goya Foods - 120 kcals, 4g fiber, 6g protein per ½ cup). The required intake of chickpeas is determined by stepwise progression of intake according to DGAs 2020-2025 and the participant's gender. Instructions for intake will be provided specifically for each participant and for each week of the study. CHK participants will receive workbooks that contain weekly adherence checklist (dosing diaries), conversion measurements, and copies of RD-prepared recipes outlining various ways to incorporate chickpeas/lentils into their diets each week as meals and/or snacks.
干预措施: Goya Foods - Canned Chickpeas (Other)
Lentil Condition
The lentil condition (LEN) includes a normal diet supplemented weekly with whole-cooked canned chickpeas for 8 weeks (Goya Foods - 80 kcals, 3g fiber, 6g protein per ½ cup). The required intake of chickpeas is determined by stepwise progression of intake according to DGAs 2020-2025 and the participant's gender. Instructions for intake will be provided specifically for each participant and for each week of the study. LEN participants will receive workbooks that contain weekly adherence checklist (dosing diaries), conversion measurements, and copies of RD-prepared recipes outlining various ways to incorporate chickpeas/lentils into their diets each week as meals and/or snacks.
干预措施: Goya Foods - Canned Lentils (Other)
Control Condition
The control (CTL) condition will be instructed to consume a normal diet while restricting all pulse intake throughout the study. CTL will receive nutrition education materials in custom workbooks on what pulses are and how to avoid intake.
干预措施: Control (Other)
结局指标
主要结局
Change in Gut Microbiome Diversity
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Gut Transit Time(Baseline (day 0), Endpoint (week 8))
- Change in Waist / Hip Circumference(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Lean Mass(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Habitual Dietary Intake(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Body Weight(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Lipid Profiles(Baseline (day 0), endpoint (week 8))
- Change in Extracellular Fluid(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Biomarkers of Inflammation(Baseline (day 0), Endpoint (week 8))
- Change in Biomarkers of Intestinal Barrier Function(Baseline (day 0), endpoint (week 8).)
- Change in Biomarkers of Appetite(Baseline (day 0), endpoint (week 8))
- Change in Rested, Seated Blood Pressure(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Fasting Blood Glucose(Baseline (day 0), endpoint (week 8).)
- Dietary Adherence(Daily, baseline through endpoint (week 8))
- Change in Body Fat Percentage(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Total Body Water(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Intracellular Fluid(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
研究者
Ravi Nagpal
Principal Investigator
Florida State University