Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women

November 20, 2020 updated by: UCSF Benioff Children's Hospital Oakland
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94609
        • Children's Hospital Oakland Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0, .5, 1, 2, 3, 4, 5 hours following a meal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in metabolic markers
Time Frame: 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.
0, .5, 1, 2, 3, 4, 5 hours following a meal

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in satiety markers
Time Frame: 0, .5, 1, 2, 3, 4, 5 hours following a meal
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.
0, .5, 1, 2, 3, 4, 5 hours following a meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCSF Benioff Children's Hospital Oakland

Investigators

  • Principal Investigator: Janet C King, PhD, Children's Hospital & Research Institute Oakland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

August 7, 2013

First Posted (ESTIMATE)

August 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHO17-ABC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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