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

Study Overview: Investigators will recruit 30 college students experiencing poor dietary quality, to participate in this 6-week pilot, single-arm clinical trial. Participants will be recruited from the metropolitan Las Vegas area through campus and community advertisements including flyers, newspaper articles, social media, and public events. Randomization will not be needed as all participants recruited will be receiving the intervention. There will be two cohorts of 15 participants for the 6-week HSNP.

Prescreen Interview: Potential participants who inquire about the study by calling the recruitment phone line or by QR code via Qualtrics, will be given a brief overview of the study and will be asked a series of questions to determine whether they should be invited for the in-person screening visit. Eligibility will be based on inclusion/exclusion criteria and responses to questions about medical history and dietary habits. Potential participants will be invited to report to the clinical facilities in the Bigelow Health Sciences Building at UNLV (study site) for their first on-site visit (and all subsequent study visits if the participant qualifies) to ascertain eligibility (screening study visit). This pre-screening interview will occur prior to participants consenting (which occurs at the in person screening study visit).

Screening Study Visit: Potentially eligible participants will be invited to the Functional Foods and Health Lab (BHS313) of the Rod Lee Bigelow, Health Sciences Building at UNLV (health assessment-study site) for their first on-site visit for screening (and subsequent 2 study visits if the participant qualifies for the future Pre and Post-HSNP Visits) to ascertain eligibility. During this screening study visit, the potential participants will be provided with verbal and written explanations of the project and will have any questions regarding the study answered by trained research personnel during the informed consent process. Consenting participants will be asked to sign an informed consent document (with a copy provided to the participant to take home). Screening will consist of determination of dietary quality using the Global Diet Quality Score, their adherence to dietary guidelines using the Rapid Prime Diet Quality Score Screener, SES Questionnaire, an Herbs and Spices Questionnaire to determine usual herbs and spices intake, and nutrition knowledge using the General Nutrition Knowledge Questionnaires. Anthropometrics and blood pressure will be measured and questions regarding medical history and medication use will be asked during the screening visit to confirm eligibility. Should the results of anthropometrics and/or blood pressure fall outside the range for inclusion, participants will be promptly notified and excluded from further participation before any additional data is collected. If participants meet the inclusion criteria for the study, they will be asked to come for subsequent study visits (Pre- and Post-HSNP Study Visits) and be a part of the 6-week HSNP Program. Participants who are not eligible will be thanked for their time and participation and told the specific reasoning for why they do not meet the inclusion criteria. Eligible participants will be asked to complete a three-day food record using NCI's Automated Self-Administered 24-Hour Dietary Assessment Tool to assess typical dietary intake and dietary quality (Healthy Eating Index [HEI]-2020 scoring), prior to their Pre-HSNP Study Visit at participants homes via a computer, ipad, or smartphone. The Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) is a web-based dietary recall system developed by the National Cancer Institute. It allows participants to self-report their dietary intake over the past 24 hours using a user-friendly interface that prompts for detailed food and beverage consumption. The tool can be distributed via a unique web link provided to participants, enabling remote data collection without requiring in-person visits.

Fecal Sample Collection for Assessment of Gut Microbiome: After participants confirm eligibility from their screening visit, they will be given a "Fecal Collection Tube" with instructions provided. Participants will be asked to collect a sample in the privacy of your own home, to bring back with them to their Pre-HSNP Study Visit. Participants will prepare and collect a fecal sample using the provided tube. The collection tube cap will be unscrewed, and a small spoon will be provided to scoop one spoonful of feces. The fecal sample will then be placed in the collection tube. Finally, participants will tighten the cap and shake to mix the contents. The sample is fine to be stored at room temperature prior to bringing to BHS313 for the pre and post-HSNP Study Visits. Participants will also receive another Fecal Collection Tube at the end of their HSNP week-3 visit at the Nutrition Center to complete prior to coming in for their Post-HSNP Study visit, following all the same procedures as above.

Pre- and Post-HSNP Study Visit: Participants will be asked to come fasted to the study site (between 7:00-10:00 A.M., 12 hours after the abstinence from caffeine and 24 hours after the last bout of moderate/heavy physical activity); vascular assessments (blood pressure, Pulse Wave Velocity, Pulse Wave Analysis) will be measured followed by body composition (Bioelectrical Impedance Analysis), finger prick blood draw (fasting blood glucose and lipid profiles, venous blood draw (inflammatory and oxidative stress biomarkers), anthropometrics (height, weight, and waist/hip circumference), assessment of fruit and vegetable intake via Raman Spectroscopy, assessment of physical activity patterns (Five-City Project Physical Activity Recall), nutrition knowledge (General Nutrition Knowledge Questionnaire), Mood State (Profile of Mood States Questionnaire), Gastrointestinal Health Questionnaires, and sleep quality (Pittsburg Sleep Quality Index).

Herbs and Spices Nutrition Education Program: Participants will visit the UNLV Nutrition Center for two visits after completion of their Pre-HSNP Study Visit at weeks 0 and 3 of the 6-week intervention to receive the HSNP in a group format (15 participants in each group), which our research team equipped with RD's has had experience creating and leading nutrition and education programs. HSNP will include an explanation of the principles and components of the Dietary Guidelines for Americans (DGA), health benefits of following the DGA, how to incorporate herbs and spices in the diet, guidance on recommended intake of various food groups, budget-friendly strategies and recipes for incorporation of herbs and spices in the diet, and supporting resources such as educational materials and online tools. Participants will then complete a sensory evaluation using the 9-point hedonic scale for 20 foods (including four different recipes for vegetables, fruits, grains/grain products, dairy products, and proteins/protein alternatives) prepared with various herbs and spices.

Dietary Assessments During Weeks 0, 2, 4, and 6 of Intervention Period: Participants will be asked to complete a three-day food record using NCI's Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool to assess typical dietary intake and diet quality (using HEI-202075) during weeks 0, 2, 4, and 6 of the intervention period. This food record can be completed at any point during weeks 0, 2, 4, and 6 of intervention the period at participants' homes via a computer or ipad.

Inclusion criteria

• 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.

Exclusion criteria

• 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
• Participating in another investigational study
• Unable or unwilling to give consent