Effect of Macadamia Nut on Cardiometabolic Risk Factors

NCT ID: NCT03801837

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2019-11-25

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.

Conditions

Cardiovascular Risk Factor; Heart Diseases; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Macadamia Nut

Intervention Type: 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

This group will continue with their Habitual Diet

Group Type: PLACEBO_COMPARATOR

Control Diet

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Macadamia Nut

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

Intervention Type: DIETARY_SUPPLEMENT

Control Diet

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

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Joan Sabate,DrPH, MD

Professor of Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joan Sabate, DrPH

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University School of Public Health

Loma Linda, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37180485 (View on PubMed)

Other Identifiers

5190008

Identifier Type: -

Identifier Source: org_study_id