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NCT06861153 · ClinicalTrials.gov registry record · NA
Pulses: Optimizing Pulse Consumption for Cardiometabolic Health
A NA study of Cardiovascular (CV) Risk and HbA1c, sponsored by University of Arizona.
- Recruiting
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 2
- Study locations
NCT06861153: Recruiting NA study of Cardiovascular (CV) Risk and HbA1c, sponsored by University of Arizona.
NCT06861153 is a NA study of Cardiovascular (CV) Risk and HbA1c that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 180 participants, above the 95-participant average among 4 other Cardiovascular (CV) Risk trials with a reported enrollment target (89% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06861153, a NA study of Cardiovascular (CV) Risk and HbA1c, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 2
- Study locations
Study Summary
This randomized clinical trial aims to evaluate the effects of consuming two different doses of pulses (1.5 cups/week or 3 cups/week) in individuals with baseline intake below 1.5 cups/week, compared to a control group receiving standard nutrition education based on the United States Department of Agriculture's (USDA) My Plate guidelines. The main question the Pulses study aims to answer is: • What is the effect of increasing pulse consumption (in a dose-response manner) on specific cardiometabolic risk factors, including LDL-C, CRP, HBA1C, and blood pressure compared to standard nutrition education? For secondary outcomes, this study aims to answer the following: • Does increased pulse consumption improve the following: overall serum lipid profile (Total cholesterol (TC), HDL-C, Triglycerides (TG), diet quality (measured by the Healthy Eating Index), and participants self-reported satisfaction with life (SWLS) and Satisfaction with Food-related Life (SWFoL). All participants will attend biweekly classes and food demonstrations. The pulses groups will learn to prepare various pulse-based recipes, while the control group will receive guidance on preparing healthy meals following the USDA MyPlate recommendations.
Primary Outcome
LDL cholesterol will be measured using a standard lipid panel. Blood samples will be collected after an overnight fast and analyzed using standardized laboratory methods. LDL cholesterol will be reported in mg/dL. Minimum Value: 0 mg/dL (theoretically, though not physiologically possible). Maximum value: No absolute upper limit, but values above 190 mg/dL are considered very high and associated with significant cardiovascular risk. Interpretation: \<100 mg/dL (Optimal, low risk). ≥190 mg/dL (Ver
Conditions Studied
Interventions
- BEHAVIORAL Pulses 1.5 cups Group
- BEHAVIORAL Pulses 3 cups Group
- BEHAVIORAL My Plate Group (Control)
Study Locations (2)
Arizona
- Tucson Village Farm - Tucson
- University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2028-09-01 |
| Phase | NA |
What NCT06861153 shows while recruiting
NCT06861153 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 95-participant average among 4 other Cardiovascular (CV) Risk trials with a reported enrollment target (89% higher).
The record links to 5 conditions, with Cardiovascular (CV) Risk appearing as the primary indexed condition, and to 3 interventions - of which Pulses 1.5 cups Group is the first listed.
NCT06861153 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT06861153 about?
NCT06861153 is a clinical study titled "Pulses: Optimizing Pulse Consumption for Cardiometabolic Health". This randomized clinical trial aims to evaluate the effects of consuming two different doses of pulses (1.5 cups/week or 3 cups/week) in individuals with baseline intake below 1.5 cups/week, compared to a control group receiving standard nutrition education based on the United States Department of A...
What is the current status of trial NCT06861153?
This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2025-07-01. Estimated completion is 2028-09-01.
What conditions does trial NCT06861153 study?
This clinical trial studies the following conditions: Cardiovascular (CV) Risk, HbA1c, Lipid Profile, Healthy Eating Index, CRP.
What interventions are being tested in trial NCT06861153?
The interventions under investigation include: Pulses 1.5 cups Group (BEHAVIORAL), Pulses 3 cups Group (BEHAVIORAL), My Plate Group (Control) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06861153?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06861153 being conducted?
This trial has 2 study locations across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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