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Completed

NCT Number: NCT03801837

Effect of Macadamia Nut on Cardiometabolic Risk Factors

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

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Key information

Conditions

Cardiovascular Risk Factor Cardiovascular Diseases Heart Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University School of Public Health

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Macadamia Nut

Dietary Supplement

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]

control diet

Dietary Supplement

Participants will continue with their Habitual Diet during this part of the intervention

Primary outcomes

  1. change in body weight

    Time frame: baseline to 18 weeks

    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

  2. change in body adiposity

    Time frame: baseline to 18 weeks

    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

  3. change in body fat mass

    Time frame: baseline to 18 weeks

    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.

  4. change in body percentage fat

    Time frame: baseline to 18 weeks

    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.

  5. change in total body water

    Time frame: baseline to 18 weeks

    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.

  6. change in skeletal muscle mass

    Time frame: baseline to 18 weeks

    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.

  7. change in lean body mass

    Time frame: baseline to 18 weeks

    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.

  8. change in dry lean mass

    Time frame: baseline to 18 weeks

    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.

  9. change in fasting plasma cholesterol (mg/dl)

    Time frame: baseline to 18 weeks

    change in fasting plasma cholesterol (mg/dl) will be measured by an enzymatic method with the use of a single aqueous reagent

  10. change in fasting plasma low density lipoprotein cholesterol (mg/dl)

    Time frame: baseline to 18 weeks

    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

  11. change in fasting plasma high density lipoprotein cholesterol (mg/dl)

    Time frame: baseline to 18 weeks

    change in fasting plasma high density lipoprotein cholesterol (mg/dl) will be measured by a two-phase reaction with calorimetric end point detection

  12. change in fasting plasma triglycerides(mg/dl)

    Time frame: baseline to 18 weeks

    change in fasting plasma triglycerides(mg/dl) will be measured by an enzymatic hydrolysis method

  13. change in serum apolipoprotein B (mg/dl)

    Time frame: baseline to 18 weeks

    change in serum apolipoprotein B (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser

  14. change in serum apolipoprotein A1 (mg/dl)

    Time frame: baseline to 18 weeks

    change in serum apolipoprotein A1 (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser

  15. change in serum small density low density lipoprotein cholesterol (mg/dl)

    Time frame: baseline to 18 weeks

    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.

  16. change in serum oxidized low density lipoprotein (mg/dl)

    Time frame: baseline to 18 weeks

    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

  17. change in fasting plasma glucose

    Time frame: baseline to 18 weeks

    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.)

  18. change in fasting plasma insulin

    Time frame: baseline to 18 weeks

    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)

  19. change in insulin resistance

    Time frame: baseline to 18 weeks

    change in insulin resistance will be measured using the Homeostatic Model Assessment calculator version 2 (HOMA2-IR)

Secondary outcomes

  1. effect modification of adiposity

    Time frame: baseline to 18 weeks

    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

  2. change in serum Interleukin -6

    Time frame: baseline to 18 weeks

    change in serum interleukin-6 (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA)

  3. change in serum tumor necrosis factor alpha

    Time frame: baseline to 18 weeks

    change in serum tumor necrosis factor alpha (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA)

  4. change in serum soluble selectin (ng/ml)

    Time frame: baseline to 18 weeks

    change in serum soluble selectin (ng/ml) will be measured by enzyme linked immunosorbent assay(ELISA)

  5. change in serum soluble -intercellular adhesion molecule 1 (ng/dl)

    Time frame: baselline to 18 weeks

    change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA)

  6. change in serum soluble -vascular adhesion molecule 1 (ng/dl)

    Time frame: baselline to 18 weeks

    change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA)

  7. change in C reactive protein

    Time frame: baseline to 18 weeks

    change in C reactive protein (mg/l) will be measured by enzyme linked immunosorbent assay(ELISA)

  8. change in Malondialdehyde

    Time frame: baseline to 18 weeks

    change in Malondialdehyde (micromole/l) will be measured by a competitive enzyme-linked immunosorbent assay

  9. change in Prostaglandin F2 alpha

    Time frame: baseline to 18 weeks

    change in Prostaglandin F2 alpha will be measured by a competitive enzyme-linked immunosorbent assay

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Macadamia Nut Effects on Adiposity and Cardiometabolic Risk Factors

Acronym: MAC

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 14, 2019
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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