Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-08-01
2026-08-01
Brief Summary
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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.
Detailed Description
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This prospective clinical study is a single-blinded, randomized control trial in adults at increased risk for cardiovascular disease (poor cholesterol profiles or overweight/obesity). There are four diet interventions: pecan LOW (6% energy from pecans), pecan MID (13% energy from pecans), pecan HIGH (20% energy from pecans), and CON (instructed to maintain their current habitual diet and abstain from any tree nut/peanut consumption for the duration of the intervention). This study protocol consists of a 28-day diet intervention that will involve substituting pecans for commonly consumed snack or meal items every day for the entire 28-day intervention or maintaining a current/usual diet.
There are a total of six testing visits: a screening visit (V0), a pre-intervention visit (V1), short weekly visits (end of weeks 1, 2, and 3; V2-V4), and a post-intervention visit (V5).
At screening (V0), qualification is confirmed based on anthropometrics and fasting blood draw, which is analyzed for a cholesterol panel and blood glucose. Additionally, energy requirements are estimated at this visit for use in the diet intervention.
At V1, participants will have anthropometrics measured, including body composition, by DEXA. Next, a certified phlebotomist places an IV catheter and takes the fasting blood sample. Then the participant consumes a high-saturated-fat meal challenge, delivering 17% of their estimated energy needs (from V0). Then the participant has blood drawn 7 times using the IV catheter over the next 4 hours.
The 28-day diet intervention will consist of research personnel providing pecans that deliver 6%, 13%, or 20% of the participant's daily energy needs (determined at V0). Participants placed in one of the three pecan diets will receive counseling at the baseline (V1) and weekly intervention visits (V2-V4) on substituting pecans for isocaloric foods from their habitual diet. Individuals randomized in the control group will be instructed to follow their habitual diet and will not be provided with any food items.
Participants return weekly (V2, V3, V4) to return study materials and collect food for the next week (if applicable). At these weekly visits, participants also have a fasting blood draw, and researchers will collect the participant's body measurements.
At the end of the 28-day dietary intervention, participants return for V5, where all procedures from V1 are repeated.
The investigators hypothesize that diets including the daily consumption of pecans will benefit health outcomes and lower cardiometabolic risk factors.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Pecan LOW
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
Pecan LOW
Participants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 28 days.
Pecan MID
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
Pecan MID
Participants are provided with a quantity of pecans that delivers 13% of the participant's estimated energy needs for 28 days.
Pecan HIGH
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
Pecan HIGH
Participants are provided with a quantity of pecans that delivers 20% of the participant's estimated energy needs for 28 days.
CONTROL
Participants are asked to maintain their current habitual diet and avoid any tree nut/peanut consumption for the entire 28-day intervention period.
CONTROL
Participants are asked to maintain their current habitual diet and to avoid any tree nut/peanut consumption for the entire 28-day intervention period.
Interventions
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Pecan LOW
Participants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 28 days.
Pecan MID
Participants are provided with a quantity of pecans that delivers 13% of the participant's estimated energy needs for 28 days.
Pecan HIGH
Participants are provided with a quantity of pecans that delivers 20% of the participant's estimated energy needs for 28 days.
CONTROL
Participants are asked to maintain their current habitual diet and to avoid any tree nut/peanut consumption for the entire 28-day intervention period.
Eligibility Criteria
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Inclusion Criteria
* 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).
* Overweight/obesity will be defined by body mass index (overweight \> 28 kg/m2 or obesity 30 kg/m2 or greater).
Exclusion Criteria
* Alcohol intake \>3 drinks/d for males or \>2 drinks/d for females
* Individuals with food allergies/sensitivities to foods provided in the study, including tree nuts, gluten, and or lactose/dairy
* 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
* Individuals adhering to special diets, including, but not limited to, the ketogenic diet, intermittent fasting, vegetarian diet, or carbohydrate-restricted diets
* Plans to begin a weight loss/exercise regime during the trial
* Weight gain or loss of more than 5% of their body weight in the past 3 months
* History of previous or current renal or bowel disease
* Females who are currently pregnant or lactating
* Individuals participating in \>3 hours/week of exercise
* Women on hormone replacement therapy for \<2 years
* Fasting glucose \>126 mg/dL
* Blood pressure \>180/120 mmHg
* History of medical or surgical events that could affect digestion or swallowing
* Gastrointestinal surgery, atherosclerosis, or bleeding disorders
* Tobacco or nicotine use
* Previous heart attack (MI) or stroke, previous or current diagnosis of cancer
* Chronic or metabolic diseases
* Medication use affecting digestion and absorption, medications affecting metabolism (e.g., thyroid meds), lipid-lowering medications, medications for diabetes, blood thinning medications
* Steroid/hormone therapies or current antibiotic cycles
30 Years
75 Years
ALL
Yes
Sponsors
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University of Georgia
OTHER
Responsible Party
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Jamie Cooper, PhD
Professor, Director of UGA Obesity Initiative
Principal Investigators
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Jamie A Cooper, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Georgia
Locations
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University of Georgia
Athens, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PROJECT00007288
Identifier Type: -
Identifier Source: org_study_id