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| Name | Class |
|---|---|
| Almond Board of California | OTHER |
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Increased abdominal adiposity is a key feature of metabolic syndrome, which describes a cluster of cardiovascular disease (CVD) risk factors that also includes insulin resistance, 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 managing obesity and metabolic syndrome, 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 abdominal obesity. 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 increased abdominal adiposity 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 increased abdominal adiposity. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Reference Diet | Active Comparator |
| |
| Almond Supplemented Diet | Experimental |
| |
| Low Carbohydrate Reference Diet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard reference diet | Other | 50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total and LDL cholesterol | Change in total and LDL cholesterol between each of the 3 test diets | 3 weeks, 8 weeks, 13 weeks |
| Change in small and medium LDL particles | Change in small and medium LDL particles between each of the 3 test diets | 3 weeks, 8 weeks, and 13 weeks |
| Change in apolipoprotein B | Change in apolipoprotein B between each of the 3 test diets | 3 weeks, 8 week, 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total/HDL-cholesterol ratio | Change in total/HDL-cholesterol ratio between each of the 3 test diets | 3 weeks, 8 weeks, 13 weeks |
| Change in LDL peak particle diameter | Change in LDL peak particle diameter between each of the 3 test diets |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald M Krauss, MD | UCSF Benioff Children's Hospital Oakland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cholesterol Research Center | Berkeley | California | 94705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30943980 | Derived | Williams PT, Bergeron N, Chiu S, Krauss RM. A randomized, controlled trial on the effects of almonds on lipoprotein response to a higher carbohydrate, lower fat diet in men and women with abdominal adiposity. Lipids Health Dis. 2019 Apr 3;18(1):83. doi: 10.1186/s12944-019-1025-4. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009765 | Obesity |
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| Almond supplemented diet | Other | 50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds |
|
| Low carbohydrate reference diet | Other | 26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat |
|
| 3 weeks, 8 week, 13 weeks |
| Change in plasma triglycerides | Change in plasma triglycerides between each of the 3 test diets | 3 weeks, 8 weeks, 13 weeks |
| Change in HDL-cholesterol | Change in HDL-cholesterol between each of the 3 test diets | 3 weeks, 8 weeks, 13 weeks |
| Change in large HDL particles | Change in large HDL particles between each of the 3 test diets | 3 weeks, 8 weeks, 13 weeks |
| Change in apolipoprotein AI | Change in apolipoprotein AI between each of the 3 test diets | 3 weeks, 8 weeks, 13 weeks |
| Change in HOMA-IR | Change in homeostatic model assessment insulin resistance (HOMA-IR) after each of the 3 test diets | 3 weeks, 8 weeks, 13 weeks |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |