DyslipidemiasNCT05949879
Dose Response Effects of Pecan Consumption
A study testing Pecan LOW, Pecan MID and Pecan HIGH in people with Dyslipidemias and Overweight and Obesity, run by University of Georgia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Overweight and Obesity, Nutrition, Healthy
- What is being tested?
- Pecan LOW, Pecan MID and Pecan HIGH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 14 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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).
Who cannot join
- 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
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the detailed description
Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Research investigating the relationship between pecan nut consumption and cardiometabolic outcomes has shown that pecan nut consumption can significantly benefit fasting and postprandial blood lipids, reduce CVD risk factors, promote weight maintenance, improve subjective and psychological markers of physiological appetite, increase total antioxidant capacity, and increase energy expenditure and fat oxidation. However, the current literature on pecan consumption and health outcomes only encompasses physiological benefits coming from a dosage of ~45g/day and above, which is above the current dietary guidelines. This study will be the first dose-response study examining the minimalist effective dose and determining the most effective dosage of pecan consumption on metabolic and cardiovascular outcomes. If lower doses of pecans in the diet are found to improve fasting and postprandial lipid metabolism and markers of chronic disease risk, these study findings could lead to improvements in health.
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
- Dyslipidemias, Overweight and Obesity, Nutrition, Healthy
- Being tested
- Pecan LOW, Pecan MID, Pecan HIGH, CONTROL
- Medical subject headings
- Dyslipidemias, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecan LOWOther
Participants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 28 days.
Pecan MIDOther
Participants are provided with a quantity of pecans that delivers 13% of the participant's estimated energy needs for 28 days.
Pecan HIGHOther
Participants are provided with a quantity of pecans that delivers 20% of the participant's estimated energy needs for 28 days.
CONTROLOther
Participants are asked to maintain their current habitual diet and to avoid any tree nut/peanut consumption for the entire 28-day intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Pecan LOW | Experimental | Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance. Receives: Other: Pecan LOW |
| Pecan MID | Experimental | Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance. Receives: Other: Pecan MID |
| Pecan HIGH | Experimental | Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance. Receives: Other: Pecan HIGH |
| CONTROL | Experimental | Participants are asked to maintain their current habitual diet and avoid any tree nut/peanut consumption for the entire 28-day intervention period. Receives: Other: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting serum lipoprotein and cholesterol concentrations
The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and apolipoprotein B (mg/dl).
Measured: Baseline, 4 weeks
Change in fasting serum lipoprotein particle numbers
The number of particles of low-density lipoproteins (LDL), LDL small, HDL large, LDL medium, lipoprotein (a) (nmol/L).
Measured: Baseline, 4 weeks
Change in fasting and postprandial plasma triglyceride concentrations
The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL).
Measured: Baseline, 4 weeks
Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations
The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mEq/L).
Measured: Baseline, 4 weeks
Change in fasting and postprandial plasma glucose concentrations
The concentration of plasma glucose before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL).
Measured: Baseline, 4 weeks
Change in fasting and postprandial plasma insulin concentrations
The concentration of plasma insulin before and after the high saturated fat meal challenge at both pre-and post-intervention visits (uU/mL).
Measured: Baseline, 4 weeks
Change in fasting and postprandial plasma appetite control hormones concentrations
The concentration of plasma appetite control hormones before and after the high saturated fat meal challenge at both pre-and post-intervention visits. Appetite control hormones include Cholecystokinin (CCK), Peptide YY (PYY), and Ghrelin (pg/mL).
Measured: Baseline, 4 weeks
Change in fasting and postprandial subjective feelings related to appetite
Visual analog scale ratings of feelings related to appetite before and after the high saturated fat meal challenge at both pre-and post-intervention visits. Subjective feelings of hunger, fullness, desire to eat, prospective consumption, and a composite appetite score are measured by visual analog scales (mm).
Measured: Baseline, 4 weeks
Change in fasting and postprandial plasma Malondialdehyde (MDA)
The concentration of MDA before and after the high saturated fat meal challenge at both pre-and post-intervention visits (nmol/mL).
Measured: Baseline, 4 weeks
Change in fasting and postprandial plasma total antioxidant capacity
Total antioxidant capacity before and after the high saturated fat meal challenge at both pre-and post-intervention visits (U/mL).
Measured: Baseline, 4 weeks
Change in fasting and postprandial plasma antioxidant parameters
Glutathione peroxidase activity, superoxide dismutase activity, and glutathione-s-transferase activity before and after the high saturated fat meal challenge at both pre-and post-intervention visits (U/mL).
Measured: Baseline, 4 weeks
Change in fasting and postprandial plasma inflammatory cytokine concentrations
The concentration of interleukin-1 beta, C reactive protein, tumor necrosis factor-alpha, and interleukin-6 before and after the high saturated fat meal challenge at both pre-and post-intervention visits (pg/mL).
Measured: Baseline, 4 weeks
Change in fasting and postprandial plasma markers of coagulation potential
The concentration of plasminogen activator inhibitor-1 and tissue factor before and after the high saturated fat meal challenge at both pre-and post-intervention visits (pg/mL).
Measured: Baseline, 4 weeks
Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins
The concentration of ANGPTL 3, ANGPTL 4, and ANGPTL 8 before and after the high saturated fat meal challenge at both pre-and post-intervention visits (ng/mL).
Measured: Baseline, 4 weeks
Change in fasting insulin resistance metrics
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment for β-cell function (HOMA-B) will be calculated from fasting insulin and glucose measures before and after the 28-day intervention.
Measured: Baseline, 4 weeks
Secondary outcomes (7)
Change in fasting serum hepatic enzymes
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), and Gamma-Glutamyl Transferase (GGT) (U/L).
Measured: Baseline, 4 weeks
Change in fasting serum hepatic proteins
Total protein and albumin (g/dL).
Measured: Baseline, 4 weeks
Change in fasting serum bilirubin
Total total bilirubin, direct bilirubin, and indirect bilirubin (mg/dL).
Measured: Baseline, 4 weeks
Change in additional fasting and postprandial plasma inflammatory cytokine concentrations
The concentration of monocyte chemoattractant protein-1 and interleukin-10 before and after the high saturated fat meal challenge at both pre-and post-intervention visits (pg/mL).
Measured: Baseline, 4 weeks
Change in additional fasting and postprandial plasma markers of coagulation potential
The concentration of Von Willebrand factor, tissue factor pathway inhibitor, fibrinogen, and D-dimer before and after the high saturated fat meal challenge at both pre-and post-intervention visits (pg/mL).
Measured: Baseline, 4 weeks
Change in overall liking and desire to consume subjective ratings of the intervention food provided
Visual analog scale ratings of feelings related to overall liking and desire to consume the intervention food are measured by visual analog scales (mm).
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Change in acute dietary intake
One-day food logs will be used to record all foods and beverages consumed on testing days.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Aug 2023
- Primary completion14 Apr 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four groups of 28-day parallel feeding trials with three groups receiving different amounts of pecans (low, mid, high) and one group serving as control (instructed to maintain their current habitual diet and avoid any nut consumption for the 28-day intervention).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Cooper, PhD, University of Georgia
- Investigators
- Jamie A Cooper, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949879
- Sponsor's protocol ID
- PROJECT00007288
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guadagni AJ, Paton CM, Cooper JA. Dose-Response Effects of Pecan Consumption on Blood Lipid Profiles in Adults with Excess Body Weight and/or Dyslipidemia: a Randomized Controlled Trial. J Nutr. 2026 Apr;156(4):101396. doi: 10.1016/j.tjnut.2026.101396. Epub 2026 Feb 4.
PubMed 41651071
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Effects of Pecan Consumption
- ClinicalTrials.gov ID
- NCT05949879
- Acronym / sponsor ID
- PROJECT00007288
- Conditions
- Dyslipidemias, Overweight and Obesity, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Research investigating the relationship between pecan nut consumption and cardiometabolic outcomes has shown that pecan nut consumption can significantly benefit fasting and postprandial blood lipids, reduce CVD risk factors, promote weight maintenance, improve subjective and psychological markers of physiological appetite, increase total antioxidant capacity, and increase energy expenditure and fat oxidation. However, the current literature on pecan consumption and health outcomes only encompasses physiological benefits coming from a dosage of ~45g/day and above, which is above the current dietary guidelines. This study will be the first dose-response study examining the minimalist effective dose and determining the most effective dosage of pecan consumption on metabolic and cardiovascular outcomes. If lower doses of pecans in the diet are found to improve fasting and postprandial lipid metabolism and markers of chronic disease risk, these study findings could lead to improvements in health.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Four groups of 28-day parallel feeding trials with three groups receiving different amounts of pecans (low, mid, high) and one group serving as control (instructed to maintain their current habitual diet and avoid any nut consumption for the 28-day intervention).
| Arm | Type | Receives |
|---|---|---|
| Pecan LOW | Experimental | Other: Pecan LOWParticipants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance. |
| Pecan MID | Experimental | Other: Pecan MIDParticipants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance. |
| Pecan HIGH | Experimental | Other: Pecan HIGHParticipants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance. |
| CONTROL | Experimental | Other: CONTROLParticipants are asked to maintain their current habitual diet and avoid any tree nut/peanut consumption for the entire 28-day intervention period. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- 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).
Key exclusion criteria (20 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pecan LOWParticipants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 28 days. | Other | Pecan LOW |
| Pecan MIDParticipants are provided with a quantity of pecans that delivers 13% of the participant's estimated energy needs for 28 days. | Other | Pecan MID |
| Pecan HIGHParticipants are provided with a quantity of pecans that delivers 20% of the participant's estimated energy needs for 28 days. | Other | Pecan HIGH |
| CONTROLParticipants are asked to maintain their current habitual diet and to avoid any tree nut/peanut consumption for the entire 28-day intervention period. | Other | CONTROL |
Primary outcome
Change in fasting serum lipoprotein and cholesterol concentrations
Time frame: Baseline, 4 weeks
The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and apolipoprotein B (mg/dl).
Change in fasting serum lipoprotein particle numbers
Time frame: Baseline, 4 weeks
The number of particles of low-density lipoproteins (LDL), LDL small, HDL large, LDL medium, lipoprotein (a) (nmol/L).
Change in fasting and postprandial plasma triglyceride concentrations
Time frame: Baseline, 4 weeks
The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL).
Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations
Time frame: Baseline, 4 weeks
The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mEq/L).
Change in fasting and postprandial plasma glucose concentrations
Time frame: Baseline, 4 weeks
The concentration of plasma glucose before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL).
Change in fasting and postprandial plasma insulin concentrations
Time frame: Baseline, 4 weeks
The concentration of plasma insulin before and after the high saturated fat meal challenge at both pre-and post-intervention visits (uU/mL).
Change in fasting and postprandial plasma appetite control hormones concentrations
Time frame: Baseline, 4 weeks
The concentration of plasma appetite control hormones before and after the high saturated fat meal challenge at both pre-and post-intervention visits. Appetite control hormones include Cholecystokinin (CCK), Peptide YY (PYY), and Ghrelin (pg/mL).
Change in fasting and postprandial subjective feelings related to appetite
Time frame: Baseline, 4 weeks
Visual analog scale ratings of feelings related to appetite before and after the high saturated fat meal challenge at both pre-and post-intervention visits. Subjective feelings of hunger, fullness, desire to eat, prospective consumption, and a composite appetite score are measured by visual analog scales (mm).
Change in fasting and postprandial plasma Malondialdehyde (MDA)
Time frame: Baseline, 4 weeks
The concentration of MDA before and after the high saturated fat meal challenge at both pre-and post-intervention visits (nmol/mL).
Change in fasting and postprandial plasma total antioxidant capacity
Time frame: Baseline, 4 weeks
Total antioxidant capacity before and after the high saturated fat meal challenge at both pre-and post-intervention visits (U/mL).
Change in fasting and postprandial plasma antioxidant parameters
Time frame: Baseline, 4 weeks
Glutathione peroxidase activity, superoxide dismutase activity, and glutathione-s-transferase activity before and after the high saturated fat meal challenge at both pre-and post-intervention visits (U/mL).
Change in fasting and postprandial plasma inflammatory cytokine concentrations
Time frame: Baseline, 4 weeks
The concentration of interleukin-1 beta, C reactive protein, tumor necrosis factor-alpha, and interleukin-6 before and after the high saturated fat meal challenge at both pre-and post-intervention visits (pg/mL).
Change in fasting and postprandial plasma markers of coagulation potential
Time frame: Baseline, 4 weeks
The concentration of plasminogen activator inhibitor-1 and tissue factor before and after the high saturated fat meal challenge at both pre-and post-intervention visits (pg/mL).
Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins
Time frame: Baseline, 4 weeks
The concentration of ANGPTL 3, ANGPTL 4, and ANGPTL 8 before and after the high saturated fat meal challenge at both pre-and post-intervention visits (ng/mL).
Change in fasting insulin resistance metrics
Time frame: Baseline, 4 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment for β-cell function (HOMA-B) will be calculated from fasting insulin and glucose measures before and after the 28-day intervention.
7 secondary outcomes
Change in fasting serum hepatic enzymes
Time frame: Baseline, 4 weeks
Change in fasting serum hepatic proteins
Time frame: Baseline, 4 weeks
Change in fasting serum bilirubin
Time frame: Baseline, 4 weeks
Change in additional fasting and postprandial plasma inflammatory cytokine concentrations
Time frame: Baseline, 4 weeks
Change in additional fasting and postprandial plasma markers of coagulation potential
Time frame: Baseline, 4 weeks
Change in overall liking and desire to consume subjective ratings of the intervention food provided
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Change in acute dietary intake
Time frame: Baseline, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 41651071Guadagni AJ, Paton CM, Cooper JA. Dose-Response Effects of Pecan Consumption on Blood Lipid Profiles in Adults with Excess Body Weight and/or Dyslipidemia: a Randomized Controlled Trial. J Nutr. 2026 Apr;156(4):101396. doi: 10.1016/j.tjnut.2026.101396. Epub 2026 Feb 4.
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Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie A Cooper, Ph.D. principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pecan LOW, Pecan MID and Pecan HIGH in people with Dyslipidemias and Overweight and Obesity, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting serum lipoprotein and cholesterol concentrations (time frame: Baseline, 4 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05949879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.