NCT07082348

Brief Summary

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

June 11, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

July 3, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 24, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

June 11, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

dietary qualitydietary guidelines for americanscollege studentscardiometabolic healthgut microbiome

Outcome Measures

Primary Outcomes (5)

  • 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.

    Pre- and Post- HSNP: 6 weeks

  • 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.

    Pre- and Post- HSNP: 6 weeks

  • 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.

    Pre- and Post- HSNP: 6 weeks

  • 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)

    Pre- and Post- HSNP: 6 weeks

  • Acceptability of HSNP

    To asses acceptability at the 3-week HSNP visit and upon completing of HSNP via survey and optional semi-structured interviews. The survey will include Likert-Scale items (1-5 and 1-10) across satisfaction, perceived relevance, taste, convenience, and likelihood of continued use.

    Pre- and Post- HSNP: 6 weeks

Secondary Outcomes (26)

  • Change in Fasting Blood Glucose Levels

    Pre- and Post- HSNP: 6 weeks

  • Change in Lipid Profiles

    Pre- and Post-HSNP: 6 weeks

  • Change in Blood Pressure

    Pre- and Post-HSNP: 6 weeks

  • Changes in Arterial Stiffness-Pulse Wave Velocity

    Pre- and Post-HSNP: 6 weeks

  • Changes in Arterial Stiffness-Augmentation Index

    Pre- and Post-HSNP: 6 weeks

  • +21 more secondary outcomes

Study Arms (1)

Herbs and Spices Nutrition Education Program

EXPERIMENTAL

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.

Behavioral: Herbs and Spices Nutrition Education Program

Interventions

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.

Herbs and Spices Nutrition Education Program

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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),
  • Maintain current lifestyle habits (e.g., medications/ supplement use, exercise, and sleep), and avoid taking new supplements or medications throughout the study.

You may not qualify if:

  • Individuals diagnosed with myocardial infarction within the past 6 months
  • Uncontrolled hypertension
  • BMIs \<18.5 or \>40 kg/m2
  • Autoimmune disease or immune compromised
  • A recent diagnosis of cancer or under current treatment for cancer
  • A history of kidney stones
  • Having pacemaker
  • Participating in a weight loss program
  • Having a history of any significant GI disease
  • Insulin use
  • Currently on dialysis
  • Currently consuming pro-/pre-biotics or antiobiotics
  • Diagnosed with unstable chronic metabolic disease
  • Have allergies to any herbs and spices
  • Are pregnant/nursing
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology and Nutrition Sciences, Las Vegas, Nevada

Las Vegas, Nevada, 89154, United States

RECRUITING

Study Officials

  • Neda S Akhavan, PhD, RD

    University of Nevada, Las Vegas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neda S Akhavan, PhD, RD

CONTACT

Sara K Rosenkranz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

July 24, 2025

Study Start

July 3, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) will not be shared because the study did not obtain participant consent for data sharing, and there are concerns regarding the protection of participant privacy and confidentiality. Additionally, institutional and regulatory policies restrict data sharing, and the data are not intended for broader dissemination.

Locations