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OpenTrials
Completed

NCT Number: NCT01919476

Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women

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.

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Key information

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Oakland Research Institute

Oakland, California, 94609, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bagel

Other

Cream Cheese

Other

Almond Butter

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 9, 2013
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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