Feasibility and Potential Efficacy of Herbs and Spices for Improving Dietary Quality in College Students: A Pilot Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorUniversity of Nevada, Las Vegas

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Herbs and Spices Nutrition Education Program

    Behavioral

    Participants 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

30 Participants
are divided into 1 treatment group
Group A: Herbs and Spices Nutrition Education ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Pre- and Post- HSNP: 6 weeks
2

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.

Time frame
Pre- and Post- HSNP: 6 weeks
3

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.

Time frame
Pre- and Post- HSNP: 6 weeks
4

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)

Time frame
Pre- and Post- HSNP: 6 weeks

Secondary outcomes

1

Change in Fasting Blood Glucose Levels

Fasting Blood Glucose Levels Measured with a Glucometer

Time frame
Pre- and Post- HSNP: 6 weeks
2

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

Time frame
Pre- and Post-HSNP: 6 weeks
3

Change in Blood Pressure

Fasted diastolic and systolic blood pressure, measured via OMRON automated blood pressure device

Time frame
Pre- and Post-HSNP: 6 weeks
4

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).

Time frame
Pre- and Post-HSNP: 6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nevada, Las Vegas

Lead sponsor

McCormick Science Institute

Collaborator