RECRUITING

Dose Response Effects of Pecan Consumption

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The bioactive compounds contained in tree nuts have been shown to beneficially affect cardiometabolic health outcomes. Pecans contain more total phenols, sterols, and flavonoids than any other tree nut. They also are a rich source of polyunsaturated fatty acids (PUFAs), fiber, vitamin A, vitamin E, folic acid, calcium, magnesium, phosphorus, potassium, and zinc. These bioactive components in pecans are likely the reason for the previously documented improvements in cardiometabolic health. The specific aims of this study are to: * Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on fasting and postprandial blood lipids. * Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on plasma markers associated with overall health. * Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on subjective and physiologic postprandial measures of hunger and satiety. Participants will be asked to: * Consume pecans daily for 28 days or maintain their current habitual diet. * Attend three short weekly visits for fasting blood craws, body measurements, and collect their next week's supply of study materials. * Attend two longer (5 h) testing visits which include consuming a standard breakfast meal and having their blood drawn periodically before and after breakfast. Researchers will compare pecan LOW, pecan MID, pecan HIGH, and the Control group to examine the physiologic effects of incorporating various dosages of pecans into one's diet.

Official Title

Dose Response Effects of Pecan Consumption

Quick Facts

Study Start:2023-08-01
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05949879

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 30 to 75-year-old men and women at increased risk of cardiovascular disease. Increased risk of cardiovascular disease will be defined by either elevated cholesterol profiles or overweight/obesity.
  2. * Elevated cholesterol profiles will be defined as: "Borderline High" and/or "at risk" in two or more of the following variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110- 159 mg/dL, triglycerides 130-199 mg/dL) --or---"High" in total cholesterol (240 mg/dL and higher), LDL (160 mg/dL or higher), or triglycerides (between 200-350 mg/dl).
  3. * Overweight/obesity will be defined by body mass index (overweight \> 28 kg/m2 or obesity 30 kg/m2 or greater).
  1. * Probable familial hypercholesterolemia, defined by: total cholesterol greater than 290 mg/dL or LDL levels greater than 190 mg/dL plus a family history of myocardial infarction (MI) before 50 years of age in a 2nd-degree relative or below age 60 in a 1st-degree relative
  2. * Alcohol intake \>3 drinks/d for males or \>2 drinks/d for females
  3. * Individuals with food allergies/sensitivities to foods provided in the study, including tree nuts, gluten, and or lactose/dairy
  4. * Individuals who regularly consume nuts and/or nut butter (defined as consumption of \>2 servings (\~56g) of tree nuts, nuts, or nut butter (e.g., peanut butter, almond butter) per week
  5. * Individuals adhering to special diets, including, but not limited to, the ketogenic diet, intermittent fasting, vegetarian diet, or carbohydrate-restricted diets
  6. * Plans to begin a weight loss/exercise regime during the trial
  7. * Weight gain or loss of more than 5% of their body weight in the past 3 months
  8. * History of previous or current renal or bowel disease
  9. * Females who are currently pregnant or lactating
  10. * Individuals participating in \>3 hours/week of exercise
  11. * Women on hormone replacement therapy for \<2 years
  12. * Fasting glucose \>126 mg/dL
  13. * Blood pressure \>180/120 mmHg
  14. * History of medical or surgical events that could affect digestion or swallowing
  15. * Gastrointestinal surgery, atherosclerosis, or bleeding disorders
  16. * Tobacco or nicotine use
  17. * Previous heart attack (MI) or stroke, previous or current diagnosis of cancer
  18. * Chronic or metabolic diseases
  19. * Medication use affecting digestion and absorption, medications affecting metabolism (e.g., thyroid meds), lipid-lowering medications, medications for diabetes, blood thinning medications
  20. * Steroid/hormone therapies or current antibiotic cycles

Contacts and Locations

Study Contact

Jamie A Cooper, Ph.D.
CONTACT
706-542-4378
jamie.cooper@uga.edu

Principal Investigator

Jamie A Cooper, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Georgia

Study Locations (Sites)

University of Georgia
Athens, Georgia, 30602
United States

Collaborators and Investigators

Sponsor: University of Georgia

  • Jamie A Cooper, Ph.D., PRINCIPAL_INVESTIGATOR, University of Georgia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2026-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Dyslipidemias
  • Overweight and Obesity
  • Nutrition, Healthy