Clinical trial NCT04487808: Diet Quality, Pecans, and Cardiometabolic Health
Official title: Cardiometabolic Effects of Including Pecans as a Snack in Dietary Patterns That Vary in Diet Quality: a Randomized, Controlled Feeding, Crossover Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cardiovascular Diseases
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: A three-period, randomized, crossover controlled feeding trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average American intake, compared to a diet representative of average American intake devoid of nuts, and a healthy dietary pattern including 2 oz./day of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.

Detailed description: Participants will be randomized to each diet for 4-weeks with a minimum 2-week break between the diet periods. All caloric foods and beverages will be provided. Outcome assessments will be done at baseline and the end of each diet period.

Eligibility criteria: Inclusion Criteria:

* BMI ≥25 and ≤40 kg/m2
* ≥ 1 criterion for metabolic syndrome (i.e. waist circumference ≥ 94 cm men or ≥80 cm women; triglycerides ≥150 mg/dL; HDL ≤ 40 mg/dL men or ≤50 mg/dL women; systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; fasting plasma glucose ≥100 mg/dL) at screening.
* non-smoking

Exclusion Criteria:

* Current tobacco use or use within the previous 6 months
* Diagnosed diabetes or fasting glucose levels \> 126 mg/dL at screening
* Systolic blood pressure \>160 mm Hg or diastolic blood pressure \> 100 mm Hg at screening.
* Use of anti-hypertensive, lipid lowering, glucose lowering drugs, steroids, or antibiotics in the previous month
* History of a cardiovascular event (heart attack, revascularization, stroke), or heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis
* Use of supplements and botanicals known to affect study outcomes (e.g. psyllium, fish oil, soy lecithin, and phytoestrogens) and not willing to cease for the duration of the study
* Pregnancy, lactation or planning to become pregnant
* Consumption of \>14 alcoholic drinks/week
* Intolerance/allergy/sensitivity to foods included in the study menus

Primary outcomes:
measure: Flow mediated dilation
timeFrame: 4 weeks
Secondary outcomes:
measure: LDL-cholesterol concentration
timeFrame: 4 weeks
measure: HDL-cholesterol concentrations
timeFrame: 4 weeks
measure: Triglycerides
timeFrame: 4 weeks
measure: LDL lipoprotein subclasses
timeFrame: 4 weeks
measure: HDL lipoprotein subclasses
timeFrame: 4 weeks
measure: Peripheral systolic and diastolic blood pressure
timeFrame: 4 weeks
measure: Central systolic and diastolic blood pressure
timeFrame: 4 weeks
measure: Carotid-femoral pulse wave velocity
timeFrame: 4 weeks
measure: Augmentation Index
timeFrame: 4 weeks
measure: Fasting plasma glucose concentration
timeFrame: 4 weeks
measure: Serum insulin concentration
timeFrame: 4 weeks
Other outcomes:
measure: Change in the composition of the gut microbiota
timeFrame: 4 weeks
Locations:
Study officials:
References: