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Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women

NCT ID: NCT01919476

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-03-31

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.

Detailed Description

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Conditions

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Diabetes, Gestational

Keywords

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Postprandial Insulin resistance Lipids Satiety Almonds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control Meal: Bagel, cream cheese

Control meal consists of bagel with cream cheese and apple juice.

Group Type ACTIVE_COMPARATOR

Bagel

Intervention Type OTHER

Cream Cheese

Intervention Type OTHER

Almond Meal: Bagel, almond butter

Almond meal consists of bagel with almond butter and apple juice.

Group Type EXPERIMENTAL

Bagel

Intervention Type OTHER

Almond Butter

Intervention Type OTHER

Interventions

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Bagel

Intervention Type OTHER

Cream Cheese

Intervention Type OTHER

Almond Butter

Intervention Type OTHER

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janet C King, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital & Research Institute Oakland

Locations

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Children's Hospital Oakland Research Institute

Oakland, California, United States

Site Status

Countries

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United States

Other Identifiers

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CHO17-ABC

Identifier Type: -

Identifier Source: org_study_id