Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women

NCT01919476 | Completed

• 1 other identifier: CHO17-ABC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes, Gestational

Keywords

Postprandial; Insulin resistance; Lipids; Satiety; Almonds

Outcome Measures

Primary Outcomes (1)

• Change in markers for glucose intolerance.

  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 Outcomes (1)

• Change in metabolic markers

  0, .5, 1, 2, 3, 4, 5 hours following a meal

Other Outcomes (1)

• Change in satiety markers

  0, .5, 1, 2, 3, 4, 5 hours following a meal

Study Arms (2)

Control Meal: Bagel, cream cheese

ACTIVE COMPARATOR

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

Other: Bagel; Other: Cream Cheese

Almond Meal: Bagel, almond butter

EXPERIMENTAL

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

Other: Bagel; Other: Almond Butter

Interventions

Bagel OTHER

Almond Meal: Bagel, almond butter; Control Meal: Bagel, cream cheese

Cream Cheese OTHER

Control Meal: Bagel, cream cheese

Almond Butter OTHER

Almond Meal: Bagel, almond butter

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant Hispanic women
• Between 30 and 36 weeks gestation
• Prepregnancy BMI between 25 and 40

You may not qualify if:

• Diagnosis of gestational diabetes mellitus
• Preexisting diabetes mellitus
• Renal disease
• Thyroid disease
• Cardiovascular disease
• History of drug abuse
• Nut allergies

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead

Study Sites (1)

Children's Hospital Oakland Research Institute

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Janet C King, PhD

  Children's Hospital & Research Institute Oakland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 9, 2013
• Study Start: September 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)