Effect of Macadamia Nut on Cardiometabolic Risk Factors

NCT03801837 | Completed

• 1 other identifier: 5190008
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiovascular Risk Factor; Heart Diseases; Inflammation

Keywords

Macadamia Nuts; Cardiovascular Disease; Inflammation

Outcome Measures

Primary Outcomes (19)

• 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 Outcomes (9)

• effect modification of adiposity

  baseline to 18 weeks

• change in serum Interleukin -6

  baseline to 18 weeks

• change in serum tumor necrosis factor alpha

  baseline to 18 weeks

• change in serum soluble selectin (ng/ml)

  baseline to 18 weeks

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

  baselline to 18 weeks

Study Arms (2)

Macadamia Nut Diet

ACTIVE COMPARATOR

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

Control Diet

PLACEBO COMPARATOR

This group will continue with their Habitual Diet

Dietary Supplement: Control Diet

Interventions

Macadamia Nut DIETARY_SUPPLEMENT

Participants will be provided with the appropriate portion of macadamia nuts \[15% of daily calories or 30-45 grams based on kcal requirement of the individual\]

Macadamia Nut Diet

Control Diet DIETARY_SUPPLEMENT

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

Control Diet

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University School of Public Health

Loma Linda, California, 92350, United States

Location

Related Publications (1)

• Jones JL, Sabate J, Heskey C, Oda K, Miles F, Rajaram S. Macadamia nut effects on cardiometabolic risk factors: a randomised trial. J Nutr Sci. 2023 May 8;12:e55. doi: 10.1017/jns.2023.39. eCollection 2023.

  PMID: 37180485 DERIVED

MeSH Terms

Conditions

Heart Diseases; Inflammation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joan Sabate, DrPH

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 14, 2019
• Study Start: June 24, 2019
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)