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

April 26, 2012
July 30, 2013
April 2013
December 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01792648 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effects of Almond Intake on Atherogenic Dyslipidemia of the Metabolic Syndrome
Effects of Almond Intake on Atherogenic Dyslipidemia of the Metabolic Syndrome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Dyslipidemia
  • Hypertriglyceridemia
  • Other: Standard reference diet
    50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat
  • Other: Almond supplemented diet
    50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds
  • Other: Low carbohydrate reference diet
    26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat
  • Active Comparator: Standard Reference Diet
    Intervention: Other: Standard reference diet
  • Experimental: Almond Supplemented Diet
    Intervention: Other: Almond supplemented diet
  • Active Comparator: Low Carbohydrate Reference Diet
    Intervention: Other: Low carbohydrate reference diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
Yes
Contact: Dani Molien 866-513-1118
United States
 
NCT01792648
MM2222
No
Children's Hospital & Research Center Oakland
Children's Hospital & Research Center Oakland
Almond Board of California
Principal Investigator: Ronald M Krauss, MD Children's Hospital & Research Center Oakland
Children's Hospital & Research Center Oakland
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP