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

NCT07043712 | Active Not Recruiting

• 1 other identifier: 2066363
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microbial Colonization; Metabolic Syndrome

Keywords

overweight; satiety; SCFA; pulses

Outcome Measures

Primary Outcomes (2)

• gut microbial change

  assessed via 16s rRNA gene sequencing from fecal samples collection

  baseline to 4 weeks

• Change in appetite hormones

  GLP-1 measurement in plasma samples

  baseline to 4 weeks

Secondary Outcomes (4)

• cardiometabolic risk factors

  baseline to 4 weeks

• Change in subjective appetite

  baseline to 4 weeks

• short chain fatty acid metabolomics

  baseline to 4 weeks

• Body composition

  baseline to 4 weeks

Study Arms (2)

High pulse consumption

EXPERIMENTAL

Subjects are provided a high pulse diet for 4-weeks. Tests include: blood biochemistries, a meal tolerance test, body composition measured via DEXA, surveys, fecal sample

Dietary Supplement: High pulse consumption

No pulse consumption

NO INTERVENTION

Subjects are provided a diet that has no pulses for 4-weeks. Tests include: blood biochemistries, a meal tolerance test, body composition measured via DEXA, surveys, fecal sample

Interventions

High pulse consumption DIETARY_SUPPLEMENT

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

High pulse consumption

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%) -

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Communicable Diseases; Metabolic Syndrome; Overweight

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Nutrition and Exercise Physiology

Model Details: Participants are randomly assigned to either the high pulse diet or no pulse diet.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)