MAC: Effect of Macadamia Nut on Cardiometabolic Risk Factors
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Macadamia Nut Diet 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
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]
|
| Placebo Comparator: Control Diet This group will continue with their Habitual Diet |
Dietary Supplement: Control Diet
Participants will continue with their Habitual Diet during this part of the intervention
|
Outcome Measures
Primary Outcome Measures
- change in body weight [baseline to 5 months]
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
- change in body adiposity [baseline to 5 months]
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
- change in body fat mass [baseline to 5 months]
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.
- change in body percentage fat [baseline to 5 months]
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.
- change in total body water [baseline to 5 months]
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.
- change in skeletal muscle mass [baseline to 5 months]
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.
- change in lean body mass [baseline to 5 months]
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.
- change in dry lean mass [baseline to 5 months]
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.
- change in fasting plasma cholesterol (mg/dl) [baseline to 5 months]
change in fasting plasma cholesterol (mg/dl) will be measured by an enzymatic method with the use of a single aqueous reagent
- change in fasting plasma low density lipoprotein cholesterol (mg/dl) [baseline to 5 months]
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
- change in fasting plasma high density lipoprotein cholesterol (mg/dl) [baseline to 5 months]
change in fasting plasma high density lipoprotein cholesterol (mg/dl) will be measured by a two-phase reaction with calorimetric end point detection
- change in fasting plasma triglycerides(mg/dl) [baseline to 5 months]
change in fasting plasma triglycerides(mg/dl) will be measured by an enzymatic hydrolysis method
- change in serum apolipoprotein B (mg/dl) [baseline to 5 months]
change in serum apolipoprotein B (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser
- change in serum apolipoprotein A1 (mg/dl) [baseline to 5 months]
change in serum apolipoprotein A1 (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser
- change in serum small density low density lipoprotein cholesterol (mg/dl) [baseline to 5 months]
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.
- change in serum oxidized low density lipoprotein (mg/dl) [baseline to 5 months]
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
Secondary Outcome Measures
- effect modification of adiposity [baseline to 5 months]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy men and post-menopausal women
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Overweight (BMI 25-<40)
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Waist circumference ≥88.9 cm for women and ≥101.6 cm for men
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At least one of the following within the past year:
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Plasma triglycerides ≥150mg/dl
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Blood Pressure ≥130/85 mmHg or participants taking Antihypertensive medication
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Fasting glucose ≥100 mg/dL
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Low Density Lipoproteins>= 130 mg/dl
Exclusion Criteria:
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Nut allergy, any
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Significant chronic disease including: diabetes, congestive heart failure, renal failure, cirrhosis, or autoimmune disease
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Medications affecting lipid or glucose metabolism, immune modulators, or antibiotics in the last 6 months
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Mega-doses of lipid-lowering dietary supplements in the last 6 months
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Cancer in the last 10 years (with the exception on non-melanoma skin cancer)
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Pregnancy or lactation
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Weight change of >10% of body weight in the last 3 months.
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Tobacco use
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Claustrophobia (may affect BOD POD testing)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loma Linda University School of Public Health | Loma Linda | California | United States | 92350 |
Sponsors and Collaborators
- Loma Linda University
Investigators
- Principal Investigator: Joan Sabate, DrPH, Loma Linda University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5190008