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OpenTrials
Active, Not Recruiting

NCT Number: NCT07043712

Effects of Pulse Consumption, Gut Microbiome, and Appetite in Healthy Participants

The purpose of the study is to investigate the effects of pulse consumption versus no pulse consumption on the gut microbiome, meal satiety, and short-chain fatty acid metabolomics.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

  • Investigate the acute and chronic effects of pulse consumption on the microbiome and plasma SCFA metabolomics in overweight subjects fed a high pulse (n=22) diet versus a no pulse containing diet (n=22).
  • Furthermore, we will quantitate the rate of production of plasma SCFA, markers of satiety (PYY, GLP-1 and ghrelin), blood lipids, and carbohydrate (CHO) metabolism (glucose levels and oxidation) during a standardized meal to determine the effects of consuming pulses on appetite and satiety after acute and chronic dietary consumption.
  • We will conduct subjective appetite assessments to investigate appetite control over the short- and long-term.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women (premenopausal only)
  • Age 20-55y (we will attempt to start baseline testing at the same time of the menstrual cycle (luteal) for the women
  • BMI ≥25 or ≤40 kg/m2 (most at risk for metabolic abnormalities and will benefit from a pulse intervention-2/3 of Americans are overweight or obese)
  • Weight stable (no fluctuations in body weight of greater than 4 kg in the last 3 months)
  • Willing to consume a research diet
  • Willing to provide blood and fecal samples
  • Sedentary to low active physical activity status (less than 7200 steps per day)
  • Stably treated with statin drugs, anti-hypertensives, and anti-depressants. These are acceptable as long as the drug category does not alter appetite, body weight, or the microbiome (if known)
  • Pre-diabetes acceptable (glucose <125 mg/dL or HbA1c < 6.5%)
  • At least one characteristic of the metabolic syndrome (but not diabetic)
  • A large waistline: 35 inches or more for women 40 inches or more for men
  • High triglycerides: 150 mg/dL or higher
  • Low HDLc level: <50 mg/dL for women <40 mg/dL for men
  • High blood pressure ≥130/85 mmHg
  • Fasting blood sugar ≥100 mg/dL - Pre-diabetes acceptable (glucose <125 mg/dL or HbA1c <6.5%) -

Exclusion criteria

  • Pregnant or lactating
  • Postmenopausal (evidence suggests an interplay between the gut microbiome)
  • BMI of <25 or >40 kg/m2
  • Use of medications that affect the gut microbiome (e.g. antibiotics)
  • Taking medications known to affect appetite (e.g., phentermine) or gastrointestinal function (e.g., metformin)
  • On a special diet or undergoing weight loss, vegetarian, or other restricted dietary patterns
  • Ad libitum intake of fiber above 25g/day (mean intake in the US population is 17g/day) and < 10g/d
  • History of disease (example colon cancer, HIV, cardiovascular disease, psychiatric disorders, etc.)
  • Use of tobacco products

Treatment and study plan

High pulse consumption

Dietary Supplement

Subjects are provided a high pulse diet for 4 weeks.collection, and anthropometrics measured.

Primary outcomes

  1. gut microbial change

    Time frame: baseline to 4 weeks

    assessed via 16s rRNA gene sequencing from fecal samples collection

  2. Change in appetite hormones

    Time frame: baseline to 4 weeks

    GLP-1 measurement in plasma samples

Secondary outcomes

  1. cardiometabolic risk factors

    Time frame: baseline to 4 weeks

    total cholesterol,

  2. Change in subjective appetite

    Time frame: baseline to 4 weeks

    Subjective fullness measured via 100 mm visual analogue scale

  3. short chain fatty acid metabolomics

    Time frame: baseline to 4 weeks

    plasma short chain fatty acids

  4. Body composition

    Time frame: baseline to 4 weeks

    Assessed via DEXA during each of two meal test visits

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Human Pulse Consumption, the Microbiome, and Meal Satiety

Acronym: PULSE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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