Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women

Study Overview
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Brief Summary
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Currently, about one third of all women entering pregnancy are obese. The prevalence of metabolic disorders during pregnancy has increased concurrently with the rise in maternal obesity. Although dietary interventions are used routinely to reduce metabolic disease in non-pregnant obese individuals, no specific dietary advice is provided to obese, pregnant women unless they develop gestational diabetes mellitus. In this study, the investigators will specifically assess the effect of replacing dairy fats with almonds in a breakfast meal on the postprandial metabolic response. This cross-over, randomized control trial will examine the postprandial metabolic response to 0 or 2 oz of almonds in standardized test meals in pregnant Hispanic women with prepregnancy BMI between 25 and 40. Hispanics are at higher risk for gestational diabetes and the metabolic syndrome. The investigators hypothesize that consuming almonds in place of dairy fat reduces the glycemic response and improves the postprandial lipid profile in these high-risk women.

Official Title
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Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women

Conditions
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Diabetes, Gestational

Intervention / Treatment
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* Other: Bagel
* Other: Cream Cheese
* Other: Almond Butter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant Hispanic women Between 30 and 36 weeks gestation Prepregnancy BMI between 25 and 40 Exclusion Criteria: Diagnosis of gestational diabetes mellitus Preexisting diabetes mellitus Renal disease Thyroid disease Cardiovascular disease History of drug abuse Nut allergies

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Meal: Bagel, cream cheese<br>Control meal consists of bagel with cream cheese and apple juice. | Other: Bagel<br> <br> Other: Cream Cheese<br> <br> |
| Experimental: Almond Meal: Bagel, almond butter<br>Almond meal consists of bagel with almond butter and apple juice. | Other: Bagel<br> <br> Other: Almond Butter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in markers for glucose intolerance. | After consuming the breakfast meal markers for glucose intolerance will be measured at the time points listed | 0, .5, 1, 2, 3, 4, 5 hours following a meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic markers | After consuming the breakfast meal metabolic markers will be measured at the time points listed. | 0, .5, 1, 2, 3, 4, 5 hours following a meal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postprandial, Insulin resistance, Lipids, Satiety, Almonds