Effects of Almond Intake on Atherogenic Lipoprotein Particles
Primary Purpose
Dyslipidemia, Obesity, Abdominal
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard reference diet
Almond supplemented diet
Low carbohydrate reference diet
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia focused on measuring Almond, Carbohydrate, Diet, Cholesterol
Eligibility Criteria
Inclusion Criteria:
- Age 20 or older
- Increased abdominal adiposity as defined by waist circumference ≥102 for men or ≥88 for women.
- 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) > 38 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 > 50mg/dl and > 500 mg/dl
- Abnormal thyroid stimulating hormone (TSH) levels.
- Pregnant or breast-feeding
Sites / Locations
- Cholesterol Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Standard Reference Diet
Almond Supplemented Diet
Low Carbohydrate Reference Diet
Arm Description
Outcomes
Primary Outcome Measures
Change in Total and LDL cholesterol
Change in total and LDL cholesterol between each of the 3 test diets
Change in small and medium LDL particles
Change in small and medium LDL particles between each of the 3 test diets
Change in apolipoprotein B
Change in apolipoprotein B between each of the 3 test diets
Secondary Outcome Measures
Change in total/HDL-cholesterol ratio
Change in total/HDL-cholesterol ratio between each of the 3 test diets
Change in LDL peak particle diameter
Change in LDL peak particle diameter between each of the 3 test diets
Change in plasma triglycerides
Change in plasma triglycerides between each of the 3 test diets
Change in HDL-cholesterol
Change in HDL-cholesterol between each of the 3 test diets
Change in large HDL particles
Change in large HDL particles between each of the 3 test diets
Change in apolipoprotein AI
Change in apolipoprotein AI between each of the 3 test diets
Change in HOMA-IR
Change in homeostatic model assessment insulin resistance (HOMA-IR) after each of the 3 test diets
Full Information
NCT ID
NCT01792648
First Posted
April 26, 2012
Last Updated
October 31, 2017
Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Almond Board of California
1. Study Identification
Unique Protocol Identification Number
NCT01792648
Brief Title
Effects of Almond Intake on Atherogenic Lipoprotein Particles
Official Title
Effects of Almond Intake on Atherogenic Lipoprotein Particles in Individuals With Increased Abdominal Adiposity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Almond Board of California
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Obesity, Abdominal
Keywords
Almond, Carbohydrate, Diet, Cholesterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Reference Diet
Arm Type
Active Comparator
Arm Title
Almond Supplemented Diet
Arm Type
Experimental
Arm Title
Low Carbohydrate Reference Diet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Standard reference diet
Intervention Description
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat
Intervention Type
Other
Intervention Name(s)
Almond supplemented diet
Intervention Description
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds
Intervention Type
Other
Intervention Name(s)
Low carbohydrate reference diet
Intervention Description
26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat
Primary Outcome Measure Information:
Title
Change in Total and LDL cholesterol
Description
Change in total and LDL cholesterol between each of the 3 test diets
Time Frame
3 weeks, 8 weeks, 13 weeks
Title
Change in small and medium LDL particles
Description
Change in small and medium LDL particles between each of the 3 test diets
Time Frame
3 weeks, 8 weeks, and 13 weeks
Title
Change in apolipoprotein B
Description
Change in apolipoprotein B between each of the 3 test diets
Time Frame
3 weeks, 8 week, 13 weeks
Secondary Outcome Measure Information:
Title
Change in total/HDL-cholesterol ratio
Description
Change in total/HDL-cholesterol ratio between each of the 3 test diets
Time Frame
3 weeks, 8 weeks, 13 weeks
Title
Change in LDL peak particle diameter
Description
Change in LDL peak particle diameter between each of the 3 test diets
Time Frame
3 weeks, 8 week, 13 weeks
Title
Change in plasma triglycerides
Description
Change in plasma triglycerides between each of the 3 test diets
Time Frame
3 weeks, 8 weeks, 13 weeks
Title
Change in HDL-cholesterol
Description
Change in HDL-cholesterol between each of the 3 test diets
Time Frame
3 weeks, 8 weeks, 13 weeks
Title
Change in large HDL particles
Description
Change in large HDL particles between each of the 3 test diets
Time Frame
3 weeks, 8 weeks, 13 weeks
Title
Change in apolipoprotein AI
Description
Change in apolipoprotein AI between each of the 3 test diets
Time Frame
3 weeks, 8 weeks, 13 weeks
Title
Change in HOMA-IR
Description
Change in homeostatic model assessment insulin resistance (HOMA-IR) after each of the 3 test diets
Time Frame
3 weeks, 8 weeks, 13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 20 or older
Increased abdominal adiposity as defined by waist circumference ≥102 for men or ≥88 for women.
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) > 38 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 > 50mg/dl and > 500 mg/dl
Abnormal thyroid stimulating hormone (TSH) levels.
Pregnant or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M Krauss, MD
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cholesterol Research Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30943980
Citation
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.
Results Reference
derived
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Effects of Almond Intake on Atherogenic Lipoprotein Particles
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