Investigating the Dose Response of an Almond-enriched Diet on Optimizing HDL-C in a Population With Hypercholesterolemia

Prior treatment

• Allergy, sensitivity, or intolerance to the investigational product/control snack ingredients
• Current regular consumption of nuts \>2 times per week, unless willing to washout prior to baseline
• Current use of prescribed lipid lowering medications as assessed by QI (see Section 7.3.1)
• Current use of over-the-counter medications or supplements known to affect blood lipid levels (i.e. omega-3) or vitamin E status
• Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
• Alcohol or drug abuse within the last 12 months

Other illness

• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant diseases of the gastrointestinal tract as assessed by QI
• Type I or Type II diabetes
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Individuals with an autoimmune disease or are immune compromised as assessed by QI
• Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
• Self-reported confirmation of blood/bleeding disorders as assessed by QI
• Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Lab values

• Clinically significant abnormal laboratory results at screening as assessed by the QI

Other

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Use of tobacco products within 12 weeks of baseline and during the study period as assessed by QI
• Alcohol intake average of \>2 standard drinks per day as assessed by the QI
• Individuals who are unable to give informed consent

• Males and Females between 30-65 years of age, inclusive
• BMI between 25.0 - 34.9 kg/m2, inclusive
• Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
  • Or,
  • Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  • Double-barrier method
  • Intrauterine devices
  • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
  • Vasectomy of partner at least 6 months prior to screening
• Individuals with hypercholesterolemia based on the NCEP definition (LDL-C levels \>4.1 mmol/L (\>160 mg/dL))
• Motivated to comply with dietary guidelines as assessed by a motivation questionnaire at screening
• Self-reported stable body weight for the past 3 months defined as not having gained or lost more than 5 kg of body weight throughout the 3 months prior to baseline
• Agrees to adhere to dietary guidelines and to maintain current lifestyle habits as much as possible throughout the study depending on the participants' ability to maintain the following: medications, supplements, exercise, and sleep and avoid taking new supplements
• Provided voluntary, written, informed consent to participate in the study
• Healthy as determined by medical history, and laboratory results exam as assessed by Qualified Investigator (QI)