About this trial
The goal of this single-arm feasibility, pilot study is to assess the feasibility, acceptability, and potential effectiveness of the Herbs and Spices Nutrition Education Program (HSNP-focusing on incorporating herbs and spices into the diet for adherence to the DGA's) for determining the scalability of implementing this intervention for a larger scale, more comprehensive study The main questions it aims to answer are:
* What is the feasibility and acceptability of incorporating herbs and spices into the diet along with DGA-focused nutrition education through the HSNP in college students with poor dietary quality? * What are the preliminary effects of the HSNP on dietary intake/quality, cardiometabolic, and gut health in college students with poor dietary quality? * What are the barriers associated with HSNP implementation in college students with poor dietary quality?
Participants will:
* Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility. * Be asked to come the clinical study site for a Pre-HSNP and Post-HSNP Study Visit (one week prior starting the HSNP and after week 6 of completing the HSNP) for assessments of cardiometabolic and gut health. * Be asked to come to the Nutrition Center for weeks 0 and 3 of the HSNP, where they will receive education on the Dietary Guidelines for Americans and the health benefits of herbs and spices, have a sensory evaluation of foods, be provided budget-friendly recipes and resources, and given take-home herbs, spices, and supporting materials * Be asked to complete 3-Day Food Records throughout the 6 week study period for assessment of dietary quality (4 total)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
College students (undergraduate and graduate)
Ages 18-39 years
BMI 18.5-40 kg/m
Having poor dietary quality (a Rapid Prime Diet Quality Score of 12 or below),
Disqualifiers
Individuals diagnosed with myocardial infarction within the past 6 months
Uncontrolled hypertension
BMIs <18.5 or >40 kg/m2
Autoimmune disease or immune compromised
Trial design
Single group
Treatments tested in this trial
Herbs and Spices Nutrition Education Program
BehavioralParticipants will attend two group visits at the UNLV Nutrition Center (weeks 0 and 3 of the 6-week intervention), where trained RDs will deliver the HSNP, covering the principles and health benefits of the Dietary Guidelines for Americans (DGA), recommended food group intake, and practical, budget-friendly strategies for incorporating herbs and spices into the diet. Sessions will include education, supporting materials, and a sensory evaluation of 20 foods (spanning fruits, vegetables, grains, dairy, and proteins) prepared with various herbs and spices, rated using a 9-point hedonic scale to identify preferred flavor profiles and promote long-term DGA adherence through enhanced taste and acceptability.
Treatment groups
Trial outcomes
Primary outcomes
Changes in Dietary Quality
Dietary Quality measured via Health Eating Index-2020 from three-day food records using NCI's Automated Self-Administered 24-Hour Dietary Assessment Tool. The index score will be from 0-100, with 0 indicating poorest diet quality and 100 excellent.
Changes In Dietary Intake
Dietary intake measured from three-day food records using NCI's Automated Self-Administered 24-Hour Dietary Assessment Tool, will be measured throughout the study period to indicate any changes in overall macro and micro nutrient intake between the treatment and comparative control group.
Feasibility of HSNP
To recruit at least 80% of the target sample size (24 out of 30 participants), retain at least 85% of enrolled participants through to the end HSNP (no more than 4 dropouts), deliver ≥90% of planned HSNP intervention, and collect ≥90% of three-day food records through the study period.
Adherence of HSNP
To have ≥80% of participants completing the whole HSNP (attending both study visits and nutrition education sessions; 24 out of 30 participants)
Secondary outcomes
Change in Fasting Blood Glucose Levels
Fasting Blood Glucose Levels Measured with a Glucometer
Change in Lipid Profiles
Measure of fasted lipid profiles (total cholesterol, triglycerides, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol) all measured in milligrams per deciliter (mg/dL) via Cholestech LDX Analyzer
Change in Blood Pressure
Fasted diastolic and systolic blood pressure, measured via OMRON automated blood pressure device
Changes in Arterial Stiffness-Pulse Wave Velocity
Fasted measured of arterial stiffness via carotid-femoral and aortic pulse wave velocity (cfPWV) in meters per second (m/s) (SphygmoCor XCEL).
Sponsors and contacts
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University of Nevada, Las Vegas
Lead sponsor
McCormick Science Institute
Collaborator