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Pulse-Based Diet for Healthy Lifestyle
N/A
Waitlist Available
Led By Moul Dey, Ph.D.
Research Sponsored by South Dakota 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 16 weeks
Awards & highlights
Study Summary
This trial aims to prove that plant-based diets with pulses as the main protein source can reduce risk of chronic diseases and improve health.
Who is the study for?
This trial is for people aged 60 or older, weighing at least 110 lbs, with normal HbA1C levels indicating generally good health. Participants should be currently following a meat-based diet without special dietary requirements and willing to eat on-site meals and provide samples. All races and sexes are welcome.Check my eligibility
What is being tested?
The study tests the effects of a pulse-protein-based diet compared to a traditional meat-based diet on various health markers in older adults. It aims to see if this plant-based diet can improve long-term health outcomes by analyzing around 500 different biomarkers.See study design
What are the potential side effects?
Since the intervention involves dietary changes, side effects may include digestive adjustments such as bloating or gas when introducing pulses into the diet. However, no specific side effects are listed as it's based on healthy lifestyle changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concentration of TMAO in blood
Fasting blood glucose concentration in blood
Frequency of sit/stand using Chair rise test
Secondary outcome measures
Balance assessment using balance and gait score
Blood pressure in mm Hg
Body weight in kilograms
+17 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Pulse basedExperimental Treatment1 Intervention
Pulse-protein-based dietary intervention
Group II: Meat basedExperimental Treatment1 Intervention
Animal protein-based dietary intervention
Find a Location
Who is running the clinical trial?
South Dakota State UniversityLead Sponsor
19 Previous Clinical Trials
9,970 Total Patients Enrolled
Moul Dey, Ph.D.Principal InvestigatorSouth Dakota State University
1 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of cancer, diabetes, heart, liver, or kidney diseases.I have not had major stomach or intestine problems in the last 3 months.I have had a heart attack or stroke in the past.I am 60 years or older and in good health.My kidney function is not normal.I mainly eat meat, have no special diet needs, and agree to follow the study's eating and testing plan.I cannot attend in-person visits for meals or tests.I use medications, probiotics, long-term antibiotics, or have used tobacco, drugs, or alcohol.My HbA1C levels are normal and I weigh at least 110 pounds.
Research Study Groups:
This trial has the following groups:- Group 1: Meat based
- Group 2: Pulse based
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Lifestyle Patient Testimony for trial: Trial Name: NCT05577858 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the key outcomes being sought from this research endeavor?
"The main outcome of this trial, evaluated over a 16-week period, looks at the fasting blood glucose concentration. Supplementary assessments include HOMA-IR (insulin and glucose concentrations), diastolic/systolic pressure measurements taken with an upper arm cuff, as well as gut microbiota composition and diversity via 16S rRNA gene sequencing."
Answered by AI
Are any new participants being accepted into this clinical research project?
"As per the clinicaltrials.gov listing, this trial is not currently recruiting participants. Its initial posting was on October 15th 2022 and its most recent edit was made on October 11th 2022; however there are 45 other trials actively enrolling patients at present."
Answered by AI
Who else is applying?
What state do they live in?
California
Missouri
Other
New Jersey
What site did they apply to?
South Dakota State University, Wagner Hall 416
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I wasn't able to apply, not in my state.
PatientReceived 2+ prior treatments
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