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| Name | Class |
|---|---|
| Almond Board of California | OTHER |
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The purpose of this study is to determine whether introducing almonds into the diet of overweight and obese Blacks and Hispanics improves body composition, decreases liver fat, and lowers cardiovascular disease profile.
The study is a randomized, controlled study aimed at testing whether almonds, consumed within a free-living, self-selected diet, improve body composition and liver fat, relative to a low-fat/high-carbohydrate cereal bar (LF-HC) in overweight and obese Blacks and Hispanics. A secondary aim is to determine whether almond consumption will lead to an overall lower CVD risk profile.
Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from almonds daily (2-3 oz) or a high-carbohydrate cereal bar (2 g of fat or less per 100 kcal) providing an equivalent amount of calories. Prescribed energy requirements will be determined for each participant individually using the Mifflin St Jeor Equation equation with an activity factor of 1.3. Participants will be asked to consume half of their food supplement as a mid-afternoon snack and the rest at a meal of their choice.
At the baseline visit, participants will be given a 2-week supply of their allocated food supplement and will obtain additional supplies at bi-weekly visits for the first 8 weeks. After the week 8 visit, participants will be given monthly rations of their food supplement, either almonds or LF-HC cereal bar, and will be asked to come to research center every 4 weeks to obtain their next supply. At those visits, body weight and blood pressure will be measured and participants will turn in weekly dietary diaries, reporting their supplement intake. Participants will also receive one random phone call every 4 weeks to provide a 24-h recall. This recall will be used as an index of dietary quality but also as a compliance check with dietary supplements. In addition, 3-day food records will be collected prior to the start of the study and during the final week to assess any dietary changes due to the intervention. A food frequency questionnaire will also be administered at screening and endpoint of the study. This food-frequency questionnaire will target nut consumption.
At the end of the study, intention to continue eating almonds or a low-fat diet will be assessed using questions adapted from de Bruijn et al. Participants in the almond group will be asked the following questions: (1) "I intend to include almonds in my diet" (+2 = yes, definitely; -2 = no, definitely); (2) "How certain are you that you will include almonds in your diet?" (+2 = very certain; -2 = very uncertain); (3) "Including almonds in my diet is" (instrumental attitude: +3 = healthy; -3 = unhealthy; affective attitude: +3 = pleasant; -3 = unpleasant); (4) "I find including almonds in my diet" (perceived behavioral control: +3 = easy; -3 = difficult). Corresponding questions for the control group will replace "include almonds" with "reduce the amount of fat". Participants will be called 4 weeks later to obtain information on their actual almond and fat intakes by questionnaire and 24-h recall.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almond | Experimental |
| |
| Cereal Bar | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almond | Dietary Supplement | Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from almonds daily for 24 weeks. Prescribed energy requirements will be determined for each participant individually using the Mifflin St Jeor Equation equation with an activity factor of 1.3. Participants will be asked to consume half of their daily almond supplement as a mid-afternoon snack and the rest at a meal of their choice. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body Composition | MRI will be used to provide information on total adipose tissue and all adipose tissue sub-compartments: visceral, subcutaneous, intermuscular. | Baseline and endpoint visits (Weeks 0 and 24) |
| Change in liver Fat | MRS will be used to provide information on liver adiposity. | Baseline and endpoint visits (weeks 0 and 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardio-metabolic risk profile | Blood draw and analyses will be used to measure total and low-density lipoprotein cholesterol, triglycerides, high-density lipoprotein cholesterol, glucose, insulin, and inflammatory markers. | Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24) |
| Change in brain-derived neutrophic factor (BDNF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Pierre St-Onge, Ph.D. | College of Physicians & Surgeons, Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Nutrition Obesity Research Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D005234 | Fatty Liver |
| D024821 | Metabolic Syndrome |
| D001835 | Body Weight |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| Cereal Bar | Dietary Supplement | Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from cereal bars daily for 24 weeks. Prescribed energy requirements will be determined for each participant individually using the Mifflin St Jeor Equation equation with an activity factor of 1.3. Participants will be asked to consume half of their daily cereal bar supplement as a mid-afternoon snack and the rest at a meal of their choice. |
|
Blood draw and analyses will be used measure BDNF. |
| Baseline, midpoint, and endpoint visits (weeks 0, 12, and 24) |
| Change in quality of life | SF-36 questionnaire will be used to assess quality of life. | Baseline and endpoint visits (weeks 0 and 24) |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |