Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women
Recruitment status was Recruiting
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:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women|
- Change in markers for glucose intolerance. [ Time Frame: 0, .5, 1, 2, 3, 4, 5 hours following a meal ] [ Designated as safety issue: No ]After consuming the breakfast meal markers for glucose intolerance will be measured at the time points listed
- Change in metabolic markers [ Time Frame: 0, .5, 1, 2, 3, 4, 5 hours following a meal ] [ Designated as safety issue: No ]After consuming the breakfast meal metabolic markers will be measured at the time points listed.
- Change in satiety markers [ Time Frame: 0, .5, 1, 2, 3, 4, 5 hours following a meal ] [ Designated as safety issue: No ]After consuming the breakfast meal satiety markers will be measured at the time points listed. Satiety questionnaires will also be given at the listed time points and food intake from a buffet will be measured.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Control Meal: Bagel, cream cheese
Control meal consists of bagel with cream cheese and apple juice.
|Other: Bagel Other: Cream Cheese|
Experimental: Almond Meal: Bagel, almond butter
Almond meal consists of bagel with almond butter and apple juice.
|Other: Bagel Other: Almond Butter|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01919476
|Contact: Lisa R Sawrey-Kubicek, MS, RD||(510) email@example.com|
|United States, California|
|Children's Hospital Oakland Research Institute||Recruiting|
|Oakland, California, United States, 94609|
|Contact: Lisa R Sawrey-Kubicek, MS, RD 510-384-8224 firstname.lastname@example.org|
|Principal Investigator: Janet C King, PhD|
|Principal Investigator:||Janet C King, PhD||Children's Hospital & Research Institute Oakland|