Microbial ColonizationPULSENCT07043712
Effects of Pulse Consumption, Gut Microbiome, and Appetite in Healthy Participants
A study testing High pulse consumption in people with Microbial Colonization and Metabolic Syndrome, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Metabolic Syndrome
- What is being tested?
- High pulse consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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%) -
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Pulse Consumption, the Microbiome, and Meal Satiety
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.
Read the detailed description
- 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.
- Conditions
- Microbial Colonization, Metabolic Syndrome
- Being tested
- High pulse consumption
- Keywords
- overweight, satiety, SCFA, pulses
- Medical subject headings
- Communicable Diseases, Metabolic Syndrome, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High pulse consumptionDietary supplement
Subjects are provided a high pulse diet for 4 weeks.collection, and anthropometrics measured.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbial change
assessed via 16s rRNA gene sequencing from fecal samples collection
Measured: baseline to 4 weeks
Change in appetite hormones
GLP-1 measurement in plasma samples
Measured: baseline to 4 weeks
Secondary outcomes (4)
cardiometabolic risk factors
total cholesterol,
Measured: baseline to 4 weeks
Change in subjective appetite
Subjective fullness measured via 100 mm visual analogue scale
Measured: baseline to 4 weeks
short chain fatty acid metabolomics
plasma short chain fatty acids
Measured: baseline to 4 weeks
Body composition
Assessed via DEXA during each of two meal test visits
Measured: baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the high pulse diet or no pulse diet.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherene Anguah, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043712
- Sponsor's protocol ID
- 2066363
- Acronym
- PULSE
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Pulse Consumption, the Microbiome, and Meal Satiety
- ClinicalTrials.gov ID
- NCT07043712
- Acronym / sponsor ID
- PULSE / 2066363
- Conditions
- Microbial Colonization, Metabolic Syndrome
- Keywords
- overweight, satiety, SCFA, pulses
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the high pulse diet or no pulse diet.
| Arm | Type | Receives |
|---|---|---|
| High pulse consumption | Experimental | Dietary Supplement: High pulse consumptionSubjects 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 |
| 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 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High pulse consumptionSubjects are provided a high pulse diet for 4 weeks.collection, and anthropometrics measured. | Dietary supplement | High pulse consumption |
Primary outcome
gut microbial change
Time frame: baseline to 4 weeks
assessed via 16s rRNA gene sequencing from fecal samples collection
Change in appetite hormones
Time frame: baseline to 4 weeks
GLP-1 measurement in plasma samples
4 secondary outcomes
cardiometabolic risk factors
Time frame: baseline to 4 weeks
Change in subjective appetite
Time frame: baseline to 4 weeks
short chain fatty acid metabolomics
Time frame: baseline to 4 weeks
Body composition
Time frame: baseline to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High pulse consumption in people with Microbial Colonization and Metabolic Syndrome, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut microbial change (time frame: baseline to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.