← Back to Search

Lentils for High Cholesterol or Inflammation

N/A
Waitlist Available
Led By Mary P Miles, PhD
Research Sponsored by Montana State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This trial will study the effect of incorporating pulse crops into the diet as a way to lower unhealthy elevations in serum bile acids, which play a role in promoting obesity-related diseases.

Who is the study for?
This trial is for adults aged 18-65 with a BMI over 27, suggesting they are overweight. It's not suitable for those allergic to wheat, dairy, or legumes; pregnant or breastfeeding women; individuals without a gallbladder; recent followers of ketogenic/paleo diets; recent antibiotic users; or anyone on medication affecting cholesterol, lipids, or inflammation.Check my eligibility
What is being tested?
The study tests whether eating lentils affects bile acids and metabolism in people who are overweight and have high triglycerides. Participants will eat lentils acutely and then daily for 12 weeks to see if it helps reduce serum bile acid levels and improve overall health.See study design
What are the potential side effects?
Since the intervention involves dietary changes (lentil consumption), side effects may include gastrointestinal discomfort such as bloating or gas. However, no significant adverse effects are expected from adding lentils to the diet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fasting Serum Metabolite Response (untargeted) to a High-Fat Meal
Gut Microbiome Composition
Peak Bile Acid Response to High-Fat Meal
+5 more
Secondary outcome measures
Acute Diet
Acute Physical Activity
Body Composition
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Lentil, then ControlExperimental Treatment2 Interventions
Participants first received a meal with 140 g of lentils in the morning. After a washout period of at least 7 days, they then received a meal with 0 g of lentils in the morning.
Group II: Control, then LentilExperimental Treatment2 Interventions
Participants first received a meal with 0 g of lentils in the morning. After a washout period of at least 7 days, they then received a meal with 140 g of lentils in the morning.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control
2011
Completed Phase 4
~15780

Who is running the clinical trial?

Montana State UniversityLead Sponsor
44 Previous Clinical Trials
1,043,820 Total Patients Enrolled
Mary P Miles, PhDPrincipal InvestigatorMontana State University
5 Previous Clinical Trials
219 Total Patients Enrolled

Media Library

Lentil Clinical Trial Eligibility Overview. Trial Name: NCT05245357 — N/A
Lipid Disorder Research Study Groups: Lentil, then Control, Control, then Lentil
Lipid Disorder Clinical Trial 2023: Lentil Highlights & Side Effects. Trial Name: NCT05245357 — N/A
Lentil 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245357 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What tangible results are anticipated from this experiment?

"This clinical trial, evaluated over the course of a single day, aims to measure Postprandial Serum Inflammatory Cytokine Response (TNF-alpha, IL-1beta, IL-6, IL-10 etc.), Visceral Adipose Tissue Volume in liters within the abdominal cavity, Acute Diet quality reported by patients online and BMI."

Answered by AI

Who is eligible to join this research program?

"To be eligible for inclusion, the participants must have a metabolic disorder and fall within an age-range of 18 to 65 years old. Additionally, they should possess a Body Mass Index greater than 27 kg/m^2. 24 individuals are being enrolled in this trial."

Answered by AI

Are there still vacancies available for the participants of this trial?

"Clinicaltrials.gov confirms that this medical research is actively recruiting participants, with the trial commencing on February 24th 2022 and the latest update posted on April 6th 2022."

Answered by AI

Is the eligibility criteria for this medical study restricted to individuals aged 65 and under?

"This research study is seeking participants who have reached the age of majority, but are under 65 years old."

Answered by AI

How many participants have been accepted into the experiment?

"Right. Clinicaltrials.gov hosts information showing that this clinical trial, which was initially posted on February 24th 2022, is still actively recruiting. Approximately 24 participants need to be gathered from one medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
Nutrition Research Laboratory
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Impact of Foods on Bile Acids, Metabolites, and Inflammation
2022. "Impact of Foods on Bile Acids, Metabolites, and Inflammation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05245357.
~0 spots leftby May 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top