Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Change in markers for glucose intolerance.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 19 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control Meal: Bagel, cream cheese
Control meal consists of bagel with cream cheese and apple juice.
Intervention: Cream Cheese (Other)
Control Meal: Bagel, cream cheese
Control meal consists of bagel with cream cheese and apple juice.
Intervention: Bagel (Other)
Almond Meal: Bagel, almond butter
Almond meal consists of bagel with almond butter and apple juice.
Intervention: Bagel (Other)
Almond Meal: Bagel, almond butter
Almond meal consists of bagel with almond butter and apple juice.
Intervention: Almond Butter (Other)
Outcomes
Primary Outcomes
Change in markers for glucose intolerance.
Time Frame: 0, .5, 1, 2, 3, 4, 5 hours following a meal
After consuming the breakfast meal markers for glucose intolerance will be measured at the time points listed
Secondary Outcomes
- Change in metabolic markers(0, .5, 1, 2, 3, 4, 5 hours following a meal)