Clinical trial NCT03801837: Effect of Macadamia Nut on Cardiometabolic Risk Factors
Official title: Macadamia Nut Effects on Adiposity and Cardiometabolic Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Heart Diseases
Inflammation
Keywords: Macadamia Nuts
Cardiovascular Disease
Inflammation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This research study will test the effects of macadamia nuts on adiposity, and traditional and emergent risk factors of cardiometabolic disease in adult men and women

Detailed description: Purpose of this study is to investigate the effects of Macadamia nuts on body weight, adiposity, , oxidative stress, glucose, insulin an lipid levels. it will a randomized cross over study that will include two study diets (Macadamia nut diet and control diet) with a wash out period of 4 weeks in between. 40 subjects will be selected and randomized into either of the two phases. During the Macadamia nut diet phase subjects will be provided the appropriate portion of Macadamia nuts (15% of daily calories or 30-45 grams based on kcal requirement of the individual, instructions will be provided on how to incorporate nuts into the diet. this phase will last for 8 weeks. During the control diet phase, subjects will continue with their normal diet and abstain from eating nuts. subjects will be tested for various outcomes at baseline and twice at the end of each phase. The intervention will last for 5 months in total.

Eligibility criteria: Inclusion Criteria:

* Healthy men and post-menopausal women
* Overweight (BMI 25-\<40)
* Waist circumference ≥88.9 cm for women and ≥101.6 cm for men
* At least one of the following within the past year:
* Plasma triglycerides ≥150mg/dl
* Blood Pressure ≥130/85 mmHg or participants taking Antihypertensive medication
* Fasting glucose ≥100 mg/dL
* Low Density Lipoproteins\>= 130 mg/dl

Exclusion Criteria:

* Nut allergy, any
* Significant chronic disease including: diabetes, congestive heart failure, renal failure, cirrhosis, or autoimmune disease
* Medications affecting lipid or glucose metabolism, immune modulators, or antibiotics in the last 6 months
* Mega-doses of lipid-lowering dietary supplements in the last 6 months
* Cancer in the last 10 years (with the exception on non-melanoma skin cancer)
* Pregnancy or lactation
* Weight change of \>10% of body weight in the last 3 months.
* Tobacco use
* Claustrophobia (may affect BOD POD testing)

Primary outcomes:
measure: change in body weight
timeFrame: baseline to 18 weeks
measure: change in body adiposity
timeFrame: baseline to 18 weeks
measure: change in body fat mass
timeFrame: baseline to 18 weeks
measure: change in body percentage fat
timeFrame: baseline to 18 weeks
measure: change in total body water
timeFrame: baseline to 18 weeks
measure: change in skeletal muscle mass
timeFrame: baseline to 18 weeks
measure: change in lean body mass
timeFrame: baseline to 18 weeks
measure: change in dry lean mass
timeFrame: baseline to 18 weeks
measure: change in fasting plasma cholesterol (mg/dl)
timeFrame: baseline to 18 weeks
measure: change in fasting plasma low density lipoprotein cholesterol (mg/dl)
timeFrame: baseline to 18 weeks
measure: change in fasting plasma high density lipoprotein cholesterol (mg/dl)
timeFrame: baseline to 18 weeks
measure: change in fasting plasma triglycerides(mg/dl)
timeFrame: baseline to 18 weeks
measure: change in serum apolipoprotein B (mg/dl)
timeFrame: baseline to 18 weeks
measure: change in serum apolipoprotein A1 (mg/dl)
timeFrame: baseline to 18 weeks
measure: change in serum small density low density lipoprotein cholesterol (mg/dl)
timeFrame: baseline to 18 weeks
measure: change in serum oxidized low density lipoprotein (mg/dl)
timeFrame: baseline to 18 weeks
measure: change in fasting plasma glucose
timeFrame: baseline to 18 weeks
measure: change in fasting plasma insulin
timeFrame: baseline to 18 weeks
measure: change in insulin resistance
timeFrame: baseline to 18 weeks
Secondary outcomes:
measure: effect modification of adiposity
timeFrame: baseline to 18 weeks
measure: change in serum Interleukin -6
timeFrame: baseline to 18 weeks
measure: change in serum tumor necrosis factor alpha
timeFrame: baseline to 18 weeks
measure: change in serum soluble selectin (ng/ml)
timeFrame: baseline to 18 weeks
measure: change in serum soluble -intercellular adhesion molecule 1 (ng/dl)
timeFrame: baselline to 18 weeks
measure: change in serum soluble -vascular adhesion molecule 1 (ng/dl)
timeFrame: baselline to 18 weeks
measure: change in C reactive protein
timeFrame: baseline to 18 weeks
measure: change in Malondialdehyde
timeFrame: baseline to 18 weeks
measure: change in Prostaglandin F2 alpha
timeFrame: baseline to 18 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Public Health
state: California
Study officials:
affiliation: Loma Linda University
name: Joan Sabate, DrPH
role: PRINCIPAL_INVESTIGATOR
References: