Effects of Pulse Consumption, Gut Microbiome, and Appetite in Healthy Participants
NCT ID: NCT07043712
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
44 participants
INTERVENTIONAL
2023-02-01
2025-12-31
Brief Summary
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Detailed Description
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2. 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.
3. We will conduct subjective appetite assessments to investigate appetite control over the short- and long-term.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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High pulse consumption
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
High pulse consumption
Subjects are provided a high pulse diet for 4 weeks.collection, and anthropometrics measured.
No pulse consumption
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
No interventions assigned to this group
Interventions
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High pulse consumption
Subjects are provided a high pulse diet for 4 weeks.collection, and anthropometrics measured.
Eligibility Criteria
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Inclusion Criteria
* 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)
1. A large waistline: 35 inches or more for women 40 inches or more for men
2. High triglycerides: 150 mg/dL or higher
3. Low HDLc level: \<50 mg/dL for women \<40 mg/dL for men
4. High blood pressure ≥130/85 mmHg
5. Fasting blood sugar ≥100 mg/dL - Pre-diabetes acceptable (glucose \<125 mg/dL or HbA1c \<6.5%) -
Exclusion Criteria
* 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
20 Years
55 Years
ALL
Yes
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Katherene Anguah
Associate Professor, Nutrition and Exercise Physiology
Locations
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University of Missouri
Columbia, Missouri, United States
Countries
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Other Identifiers
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2066363
Identifier Type: -
Identifier Source: org_study_id