Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women

Not Applicable

Completed

• Conditions: Diabetes, Gestational
• Interventions: Other: Bagel; Other: Cream Cheese; Other: Almond Butter

• Registration Number: NCT01919476
• Lead Sponsor: UCSF Benioff Children's Hospital Oakland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Meal: Bagel, cream cheese	Bagel	Control meal consists of bagel with cream cheese and apple juice.
Control Meal: Bagel, cream cheese	Cream Cheese	Control meal consists of bagel with cream cheese and apple juice.
Almond Meal: Bagel, almond butter	Bagel	Almond meal consists of bagel with almond butter and apple juice.
Almond Meal: Bagel, almond butter	Almond Butter	Almond meal consists of bagel with almond butter and apple juice.

Primary Outcome Measures

Name	Time	Method
Change in markers for glucose intolerance.	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 Outcome Measures

Name	Time	Method
Change in metabolic markers	0, .5, 1, 2, 3, 4, 5 hours following a meal	After consuming the breakfast meal metabolic markers will be measured at the time points listed.

Trial Locations

Locations (1)

Children's Hospital Oakland Research Institute; 🇺🇸 Oakland, California, United States