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Effects of Almond Intake on Atherogenic Dyslipidemia of the Metabolic Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Hospital & Research Center Oakland
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01792648
First received: April 26, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

Metabolic syndrome includes a cluster of cardiovascular disease (CVD) risk factors including insulin resistance, abdominal obesity, high blood pressure and an atherogenic lipoprotein phenotype characterized by increased plasma triglycerides, low HDL-C, and increased levels of small LDL particles. While lifestyle intervention remains the cornerstone for its management, the optimal dietary macronutrient distribution for improving blood lipids and CVD risk remains a topic of controversy. While both low carbohydrate diets and weight reduction are effective for managing atherogenic dyslipidemia, long-term compliance is low, and it becomes imperative to identify alternative dietary approaches.

Increased consumption of almonds has been shown to lower LDL-C, an effect that exceeds that predicted from changes in fatty acid intake. However, although LDL-C lowering by almonds has been demonstrated in patients with diabetes, there have been no trials in non-diabetic patients with metabolic syndrome. Moreover, there is limited information of the effects of almond intake on LDL particle subclasses.

The overall objective of the present study is to determine whether lipoprotein measures of CVD risk in individuals with the metabolic syndrome are reduced by almond supplementation in a diet with overall macronutrient content that conforms to current guidelines. Our main hypothesis is that in these individuals, almond consumption can reduce levels of small and medium LDL particles without the need to restrict dietary carbohydrates to levels below those currently recommended.

This hypothesis will be tested by comparing the lipoprotein effects of an almond-supplemented diet (20%E) with those of two reference diets that do not contain almond products: one with similar content of carbohydrate, protein, and fat (standard reference), and the other in which carbohydrate content is reduced by substitution of protein and monounsaturated fat (low-carbohydrate reference).

We will provide the diets for 3 weeks each in a randomized 3-period crossover design to 40 individuals with atherogenic dyslipidemia of the metabolic syndrome. We will test whether the almond supplemented diet will result in lower levels of lipoprotein measures of CVD risk, specifically LDL-C and small and medium LDL particles, compared to either the standard or low-carbohydrate reference diets.


Condition Intervention
Metabolic Syndrome
Dyslipidemia
Hypertriglyceridemia
Other: Standard reference diet
Other: Almond supplemented diet
Other: Low carbohydrate reference diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Almond Intake on Atherogenic Dyslipidemia of the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Change in Total and LDL cholesterol [ Time Frame: 3 weeks, 8 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Change in total and LDL cholesterol between each of the 3 test diets

  • Change in small and medium LDL particles [ Time Frame: 3 weeks, 8 weeks, and 13 weeks ] [ Designated as safety issue: No ]
    Change in small and medium LDL particles between each of the 3 test diets

  • Change in apolipoprotein B [ Time Frame: 3 weeks, 8 week, 13 weeks ] [ Designated as safety issue: No ]
    Change in apolipoprotein B between each of the 3 test diets


Secondary Outcome Measures:
  • Change in total/HDL-cholesterol ratio [ Time Frame: 3 weeks, 8 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Change in total/HDL-cholesterol ratio between each of the 3 test diets

  • Change in LDL peak particle diameter [ Time Frame: 3 weeks, 8 week, 13 weeks ] [ Designated as safety issue: No ]
    Change in LDL peak particle diameter between each of the 3 test diets

  • Change in plasma triglycerides [ Time Frame: 3 weeks, 8 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Change in plasma triglycerides between each of the 3 test diets

  • Change in HDL-cholesterol [ Time Frame: 3 weeks, 8 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Change in HDL-cholesterol between each of the 3 test diets

  • Change in large HDL particles [ Time Frame: 3 weeks, 8 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Change in large HDL particles between each of the 3 test diets

  • Change in apolipoprotein AI [ Time Frame: 3 weeks, 8 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Change in apolipoprotein AI between each of the 3 test diets

  • Change in HOMA-IR [ Time Frame: 3 weeks, 8 weeks, 13 weeks ] [ Designated as safety issue: No ]
    Change in homeostatic model assessment insulin resistance (HOMA-IR) after each of the 3 test diets


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Reference Diet Other: Standard reference diet
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat
Experimental: Almond Supplemented Diet Other: Almond supplemented diet
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds
Active Comparator: Low Carbohydrate Reference Diet Other: Low carbohydrate reference diet
26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 20 or older
  • Plasma triglycerides ≥ 150mg/dL and plasma HDL-C < 40 mg/dL (men) or < 50 mg/dL (women) and at least one additional metabolic syndrome criteria: waist circumference > 102 cm (men) or > 88 cm (women), blood pressure ≥ 130/≥ 85 mmHg, or fasting glucose ≥ 110mg/dL.
  • Fasting blood sugar (FBS) < 126 mg/dl
  • Weight stable for > 3 months.

Exclusion Criteria:

  • History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
  • Taking hormones or drugs known to affect lipid metabolism or blood pressure.
  • Systolic blood pressure > 160 mm Hg and diastolic blood pressure > 95 mm Hg.
  • Body mass index (BMI) > 35 kg/m2
  • User of nicotine products or recreational drugs
  • Refusal to abstain from alcohol or dietary supplements during the study.
  • Total- and LDL-C > 95th percentile for sex and age.
  • Fasting triglycerides > 500 mg/dl
  • Abnormal thyroid stimulating hormone (TSH) levels.
  • Pregnant or breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792648

Contacts
Contact: Dani Molien 866-513-1118

Locations
United States, California
Cholesterol Research Center Recruiting
Berkeley, California, United States, 94705
Contact: Megan Bennett    510-665-0500    CRCinfo@chori.org   
Principal Investigator: Ronald M Krauss, MD         
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Almond Board of California
Investigators
Principal Investigator: Ronald M Krauss, MD Children's Hospital & Research Center Oakland
  More Information

No publications provided

Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01792648     History of Changes
Other Study ID Numbers: MM2222
Study First Received: April 26, 2012
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
Almond
Carbohydrate
Diet
Cholesterol

Additional relevant MeSH terms:
Dyslipidemias
Hypertriglyceridemia
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Hyperlipidemias
Insulin Resistance
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014