Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Children's Hospital & Research Center Oakland
Sponsor:
Information provided by (Responsible Party):
Janet King, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01919476
First received: July 31, 2013
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Diabetes, Gestational
Other: Bagel
Other: Cream Cheese
Other: Almond Butter

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 20
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919476

Contacts
Contact: Lisa R Sawrey-Kubicek, MS, RD (510) 384-8224 lsawreykubicek@chori.org

Locations
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    lsawreykubicek@chori.org   
Principal Investigator: Janet C King, PhD         
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Investigators
Principal Investigator: Janet C King, PhD Children's Hospital & Research Institute Oakland
  More Information

No publications provided

Responsible Party: Janet King, Interim Senior Vice President, Research and Executive Director, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01919476     History of Changes
Other Study ID Numbers: CHO17-ABC
Study First Received: July 31, 2013
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
Postprandial
Insulin resistance
Lipids
Satiety
Almonds

Additional relevant MeSH terms:
Overweight
Diabetes, Gestational
Body Weight
Signs and Symptoms
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014