Diets Enriched With Pecans

  • STATUS
    Recruiting
  • participants needed
    114
  • sponsor
    University of Georgia
Send
Updated on 16 February 2024
See if I qualify
cardiovascular disease
cholesterol level
LDL Cholesterol
low density lipoprotein
cholesterol measurement

Summary

Background: Previous studies report that daily pecan consumption reduces cholesterol in healthy adults while promoting weight maintenance.

Purpose: To examine the impact of daily pecan consumption with and without dietary substitution instructions for an 8-week period on markers of health in adults at risk for cardiovascular disease.

Description

This was a single-blind, randomized controlled trial. The investigators recruited subjects with hypercholesterolemia (high blood cholesterol levels) or at higher risk for cardiovascular disease (CVD) (BMI > 28 kg/m2). Subjects were randomized into one of three groups: (1) the no nut group (CON), (2) pecan ADD (no diet instructions), and (3) pecan SUB (instructions to substitute pecans with isocaloric foods in habitual diet).

There was a screening visit and 3 testing visits: Baseline (visit 1), mid-visit at week 4 (visit 2), and post-visit at week 8 (visit 3). Anthropometrics, questionnaires, and a fasting blood sample were collected at each visit. A subset of participants participated in a saturated fatty acid meal challenge in which additional blood and metabolism measurements were collected.

Hypothesis: The investigators hypothesized that daily pecan consumption would result in significantly greater improvements in blood lipids, metabolism, and appetite compared to the control group. The investigators also hypothesized that pecan ADD group will result in a larger increase in body weight compared to the pecan SUB and control groups.

Details
Condition Hypercholesterolemia, Obesity, Obesity, Hyperlipidemia
Age 30years - 75years
Treatment Pecan ADD, Pecan SUB
Clinical Study IdentifierNCT04376632
SponsorUniversity of Georgia
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Ages 30-75y with higher cholesterol levels or BMI of 28 kg/m2 or greater (A higher cholesterol level is indicated by "Borderline High/Undesirable" in two or more of the variables (total cholesterol 200-239 mg/dL, LDL cholesterol 130-159 mg/dL, triglycerides 150-199 mg/dL) or "High" in either total cholesterol (240 mg/dL and higher) or LDL (160 mg/dL or higher)

Exclusion Criteria

Familial hypercholesterolemia (individuals with LDL levels greater than the 95th percentile or HDL levels lower than the 20th percentile based on age and sex)
Nut consumption >2 servings/week or tree nut butter consumption >3 servings/week
Hormone replacement therapy <5 years
Women who are pregnant or planning to become pregnant
Regular exercise of >3 hours/week
Weight gain or loss of >5% of body weight during last 3 months
Plans to begin a weight loss/exercise regiment
History of medical or surgical events that could affect digestion or swallowing
Gastrointestinal surgeries, conditions or disorders
Chronic or metabolic diseases
Atherosclerosis, previous myocardial infarction, stroke, cancer
Fasting blood glucose levels >126 mg/dl
Blood pressure >180/120 mmHg
Medication use that affects digestion, absorption, metabolism
Lipid-lowering medications
Medications for diabetes or attention deficit disorders (with or without hyperactivity)
Steroid/hormone therapies
Individuals on medically prescribed or special diet
Individuals with food allergies to foods specifically in the study
Individuals taking fish oil supplements
Excessive alcohol consumption (greater than 3 drinks/d for men; greater than 2 drinks/d for women)
Tobacco or nicotine use
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

cardiovascular disease
cholesterol level
LDL Cholesterol
low density lipoprotein
cholesterol measurement

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.