Effect of Macadamia Nut on Cardiometabolic Risk Factors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Macadamia Nut Effects on Adiposity and Cardiometabolic Risk Factors

Conditions
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Cardiovascular Risk Factor, Heart Diseases, Inflammation

Intervention / Treatment
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* Dietary Supplement: Macadamia Nut
* Dietary Supplement: Control Diet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Macadamia Nut Diet<br>This group will have their habitual diet supplemented with appropriate portion of Macadamia Nuts (15% of daily calories or 30-45 grams based on Kcal requirement of the individual) | Dietary Supplement: Macadamia Nut<br>* Participants will be provided with the appropriate portion of macadamia nuts [15% of daily calories or 30-45 grams based on kcal requirement of the individual]<br>|
| Placebo Comparator: Control Diet<br>This group will continue with their Habitual Diet | Dietary Supplement: Control Diet<br>* Participants will continue with their Habitual Diet during this part of the intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body weight | The objective of this measure is to see if eating macadamia nuts could reduce body weight. An In body machine will be used to identify this by measuring the weight of the participants at the baseline and at the end of each diet phase. The weight will be measured in Kilograms | baseline to 18 weeks | 
| change in body adiposity | The objective of this measure is to see if eating Macadamia Nuts could reduce percentage body fat. Air Displacement Plethysmography will be used to determine any change in body percentage fat at the baseline and end of each diet phase | baseline to 18 weeks | 
| change in body fat mass | The objective of this measure is to see if eating Macadamia nuts could change body fat mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method. | baseline to 18 weeks | 
| change in body percentage fat | The objective of this measure is to see if eating Macadamia nuts could change body percentage fat at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method. | baseline to 18 weeks | 
| change in total body water | The objective of this measure is to see if eating Macadamia nuts could change total body water at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method. | baseline to 18 weeks | 
| change in skeletal muscle mass | The objective of this measure is to see if eating Macadamia nuts could change skeletal muscle mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method. | baseline to 18 weeks | 
| change in lean body mass | The objective of this measure is to see if eating Macadamia nuts could change lean body mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method. | baseline to 18 weeks | 
| change in dry lean mass | The objective of this measure is to see if eating Macadamia nuts could change dry lean mass at the baseline and end of each diet phase using In Body device (InBody570, Seoul, Korea) that utilizes bioelectric impedance method. | baseline to 18 weeks | 
| change in fasting plasma cholesterol (mg/dl) | change in fasting plasma cholesterol (mg/dl) will be measured by an enzymatic method with the use of a single aqueous reagent | baseline to 18 weeks | 
| change in fasting plasma low density lipoprotein cholesterol (mg/dl) | change in fasting plasma low density lipoprotein cholesterol (mg/dl) will be estimated by the use of a two reagent calorimetric enzymatic homogeneous system on the AU480 clinical chemistry analyzer | baseline to 18 weeks | 
| change in fasting plasma high density lipoprotein cholesterol (mg/dl) | change in fasting plasma high density lipoprotein cholesterol (mg/dl) will be measured by a two-phase reaction with calorimetric end point detection | baseline to 18 weeks | 
| change in fasting plasma triglycerides(mg/dl) | change in fasting plasma triglycerides(mg/dl) will be measured by an enzymatic hydrolysis method | baseline to 18 weeks | 
| change in serum apolipoprotein B (mg/dl) | change in serum apolipoprotein B (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser | baseline to 18 weeks | 
| change in serum apolipoprotein A1 (mg/dl) | change in serum apolipoprotein A1 (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser | baseline to 18 weeks | 
| change in serum small density low density lipoprotein cholesterol (mg/dl) | change in serum small density low density lipoprotein cholesterol (mg/dl) will be measured using a two reagent calorimetric enzymatic homogenous system on the AU480 clinical chemistry analyzer. | baseline to 18 weeks | 
| change in serum oxidized low density lipoprotein (mg/dl) | change in serum oxidized low density lipoprotein (mg/dl) will be measured using a sandwich enzyme-linked immunosorbent assay, Human oxidized low density lipoprotein enzyme linked immunosorbent assay kit | baseline to 18 weeks | 
| change in fasting plasma glucose | change in fasting plasma glucose levels (mg/dl) will be measured on a clinical chemistry analyzer,AU480 Clinical Chemistry Analyzer, (Beckman Coulter, Inc., Diagnostics Division Headquarters, Brea CA 92821.) | baseline to 18 weeks | 
| change in fasting plasma insulin | change in fasting plasma insulin (uIU/ml) will be measured measured by solid-phase, two-site chemiluminescent immunometric assays using the IMMULITE 2000, (Siemens Healthcare Diagnostics, Los Angeles, CA 90045) | baseline to 18 weeks | 
| change in insulin resistance | change in insulin resistance will be measured using the Homeostatic Model Assessment calculator version 2 (HOMA2-IR) | baseline to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect modification of adiposity | The objective of this measure is to determine if adiposity is an effect modifier of low density lipoprotein cholesterol, lowering the effect of the macadamia nut intake. The test of this interaction will be performed using statistical analysis system (SAS) software | baseline to 18 weeks | 
| change in serum Interleukin -6 | change in serum interleukin-6 (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA) | baseline to 18 weeks | 
| change in serum tumor necrosis factor alpha | change in serum tumor necrosis factor alpha (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA) | baseline to 18 weeks | 
| change in serum soluble selectin (ng/ml) | change in serum soluble selectin (ng/ml) will be measured by enzyme linked immunosorbent assay(ELISA) | baseline to 18 weeks | 
| change in serum soluble -intercellular adhesion molecule 1 (ng/dl) | change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA) | baselline to 18 weeks | 
| change in serum soluble -vascular adhesion molecule 1 (ng/dl) | change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA) | baselline to 18 weeks | 
| change in C reactive protein | change in C reactive protein (mg/l) will be measured by enzyme linked immunosorbent assay(ELISA) | baseline to 18 weeks | 
| change in Malondialdehyde | change in Malondialdehyde (micromole/l) will be measured by a competitive enzyme-linked immunosorbent assay | baseline to 18 weeks | 
| change in Prostaglandin F2 alpha | change in Prostaglandin F2 alpha will be measured by a competitive enzyme-linked immunosorbent assay | baseline to 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macadamia Nuts, Cardiovascular Disease, Inflammation