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Effect of Macadamia Nut on Cardiometabolic Risk Factors (MAC)

Primary Purpose

Cardiovascular Risk Factor, Heart Diseases, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Macadamia Nut
Control Diet
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Risk Factor focused on measuring Macadamia Nuts, Cardiovascular Disease, Inflammation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Loma Linda University School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Macadamia Nut Diet

Control Diet

Arm Description

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)

This group will continue with their Habitual Diet

Outcomes

Primary Outcome Measures

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
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
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.
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.
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.
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.
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.
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.
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
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
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
change in fasting plasma triglycerides(mg/dl)
change in fasting plasma triglycerides(mg/dl) will be measured by an enzymatic hydrolysis method
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
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
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.
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
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.)
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)
change in insulin resistance
change in insulin resistance will be measured using the Homeostatic Model Assessment calculator version 2 (HOMA2-IR)

Secondary Outcome Measures

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
change in serum Interleukin -6
change in serum interleukin-6 (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA)
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)
change in serum soluble selectin (ng/ml)
change in serum soluble selectin (ng/ml) will be measured by enzyme linked immunosorbent assay(ELISA)
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)
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)
change in C reactive protein
change in C reactive protein (mg/l) will be measured by enzyme linked immunosorbent assay(ELISA)
change in Malondialdehyde
change in Malondialdehyde (micromole/l) will be measured by a competitive enzyme-linked immunosorbent assay
change in Prostaglandin F2 alpha
change in Prostaglandin F2 alpha will be measured by a competitive enzyme-linked immunosorbent assay

Full Information

First Posted
January 7, 2019
Last Updated
March 17, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT03801837
Brief Title
Effect of Macadamia Nut on Cardiometabolic Risk Factors
Acronym
MAC
Official Title
Macadamia Nut Effects on Adiposity and Cardiometabolic Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Heart Diseases, Inflammation
Keywords
Macadamia Nuts, Cardiovascular Disease, Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Macadamia Nut Diet
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Control Diet
Arm Type
Placebo Comparator
Arm Description
This group will continue with their Habitual Diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Macadamia Nut
Intervention Description
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]
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Diet
Intervention Description
Participants will continue with their Habitual Diet during this part of the intervention
Primary Outcome Measure Information:
Title
change in body weight
Description
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
Time Frame
baseline to 18 weeks
Title
change in body adiposity
Description
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
Time Frame
baseline to 18 weeks
Title
change in body fat mass
Description
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.
Time Frame
baseline to 18 weeks
Title
change in body percentage fat
Description
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.
Time Frame
baseline to 18 weeks
Title
change in total body water
Description
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.
Time Frame
baseline to 18 weeks
Title
change in skeletal muscle mass
Description
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.
Time Frame
baseline to 18 weeks
Title
change in lean body mass
Description
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.
Time Frame
baseline to 18 weeks
Title
change in dry lean mass
Description
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.
Time Frame
baseline to 18 weeks
Title
change in fasting plasma cholesterol (mg/dl)
Description
change in fasting plasma cholesterol (mg/dl) will be measured by an enzymatic method with the use of a single aqueous reagent
Time Frame
baseline to 18 weeks
Title
change in fasting plasma low density lipoprotein cholesterol (mg/dl)
Description
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
Time Frame
baseline to 18 weeks
Title
change in fasting plasma high density lipoprotein cholesterol (mg/dl)
Description
change in fasting plasma high density lipoprotein cholesterol (mg/dl) will be measured by a two-phase reaction with calorimetric end point detection
Time Frame
baseline to 18 weeks
Title
change in fasting plasma triglycerides(mg/dl)
Description
change in fasting plasma triglycerides(mg/dl) will be measured by an enzymatic hydrolysis method
Time Frame
baseline to 18 weeks
Title
change in serum apolipoprotein B (mg/dl)
Description
change in serum apolipoprotein B (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser
Time Frame
baseline to 18 weeks
Title
change in serum apolipoprotein A1 (mg/dl)
Description
change in serum apolipoprotein A1 (mg/dl) will be measured by an immuno-turbidimetric procedure using AU480 clinical chemistry analyser
Time Frame
baseline to 18 weeks
Title
change in serum small density low density lipoprotein cholesterol (mg/dl)
Description
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.
Time Frame
baseline to 18 weeks
Title
change in serum oxidized low density lipoprotein (mg/dl)
Description
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
Time Frame
baseline to 18 weeks
Title
change in fasting plasma glucose
Description
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.)
Time Frame
baseline to 18 weeks
Title
change in fasting plasma insulin
Description
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)
Time Frame
baseline to 18 weeks
Title
change in insulin resistance
Description
change in insulin resistance will be measured using the Homeostatic Model Assessment calculator version 2 (HOMA2-IR)
Time Frame
baseline to 18 weeks
Secondary Outcome Measure Information:
Title
effect modification of adiposity
Description
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
Time Frame
baseline to 18 weeks
Title
change in serum Interleukin -6
Description
change in serum interleukin-6 (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA)
Time Frame
baseline to 18 weeks
Title
change in serum tumor necrosis factor alpha
Description
change in serum tumor necrosis factor alpha (pg/ml) will be measured by enzyme linked immunosorbent assay(ELISA)
Time Frame
baseline to 18 weeks
Title
change in serum soluble selectin (ng/ml)
Description
change in serum soluble selectin (ng/ml) will be measured by enzyme linked immunosorbent assay(ELISA)
Time Frame
baseline to 18 weeks
Title
change in serum soluble -intercellular adhesion molecule 1 (ng/dl)
Description
change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA)
Time Frame
baselline to 18 weeks
Title
change in serum soluble -vascular adhesion molecule 1 (ng/dl)
Description
change in serum soluble -intercellular adhesion molecule 1 (ng/dl)will be measured by enzyme linked immunosorbent assay(ELISA)
Time Frame
baselline to 18 weeks
Title
change in C reactive protein
Description
change in C reactive protein (mg/l) will be measured by enzyme linked immunosorbent assay(ELISA)
Time Frame
baseline to 18 weeks
Title
change in Malondialdehyde
Description
change in Malondialdehyde (micromole/l) will be measured by a competitive enzyme-linked immunosorbent assay
Time Frame
baseline to 18 weeks
Title
change in Prostaglandin F2 alpha
Description
change in Prostaglandin F2 alpha will be measured by a competitive enzyme-linked immunosorbent assay
Time Frame
baseline to 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Sabate, DrPH
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University School of Public Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Macadamia Nut on Cardiometabolic Risk Factors

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