Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women

Diabetes, Gestational Clinical Trial

Official title:

Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919476
• Other study ID #: CHO17-ABC
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: March 2016

Study information

• Verified date: November 2020
• Source: UCSF Benioff Children's Hospital Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Overweight

Intervention

Other:
• Bagel

• Cream Cheese

• Almond Butter

Locations

Country	Name	City	State
United States	Children's Hospital Oakland Research Institute	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
UCSF Benioff Children's Hospital Oakland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in satiety markers	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
Primary	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	Change in metabolic markers	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