Effect of Macadamia Nut on Cardiometabolic Risk Factors (MAC)

Loma Linda University (LLU)

Status: Completed

Conditions: Inflammation; Heart Diseases; Cardiovascular Risk Factor

Treatments: Dietary Supplement: Macadamia Nut; Dietary Supplement: Control Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03801837

5190008

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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38 participants in 2 patient groups, including a placebo group

Macadamia Nut Diet

Active Comparator group

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)

Treatment:

Dietary Supplement: Macadamia Nut

Control Diet

Placebo Comparator group

Description:

This group will continue with their Habitual Diet

Treatment:

Dietary Supplement: Control Diet