Effects of Almond Intake on Atherogenic Dyslipidemia of the Metabolic Syndrome
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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 |
- 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
- 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 |
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| Contact: Dani Molien | 866-513-1118 |
| United States, California | |
| Cholesterol Research Center | Not yet recruiting |
| Berkeley, California, United States, 94705 | |
| Principal Investigator: Ronald M Krauss, MD | |
| 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: | February 13, 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:
|
Hypertriglyceridemia Dyslipidemias Metabolic Syndrome X Hyperlipidemias Lipid Metabolism Disorders |
Metabolic Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders |
ClinicalTrials.gov processed this record on May 19, 2013