Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women
Primary Purpose
Diabetes, Gestational
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bagel
Cream Cheese
Almond Butter
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes, Gestational focused on measuring Postprandial, Insulin resistance, Lipids, Satiety, Almonds
Eligibility 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
Sites / Locations
- Children's Hospital Oakland Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Meal: Bagel, cream cheese
Almond Meal: Bagel, almond butter
Arm Description
Control meal consists of bagel with cream cheese and apple juice.
Almond meal consists of bagel with almond butter and apple juice.
Outcomes
Primary Outcome Measures
Change in markers for glucose intolerance.
After consuming the breakfast meal markers for glucose intolerance will be measured at the time points listed
Secondary Outcome Measures
Change in metabolic markers
After consuming the breakfast meal metabolic markers will be measured at the time points listed.
Full Information
NCT ID
NCT01919476
First Posted
July 31, 2013
Last Updated
November 20, 2020
Sponsor
UCSF Benioff Children's Hospital Oakland
1. Study Identification
Unique Protocol Identification Number
NCT01919476
Brief Title
Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women
Official Title
Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational
Keywords
Postprandial, Insulin resistance, Lipids, Satiety, Almonds
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Meal: Bagel, cream cheese
Arm Type
Active Comparator
Arm Description
Control meal consists of bagel with cream cheese and apple juice.
Arm Title
Almond Meal: Bagel, almond butter
Arm Type
Experimental
Arm Description
Almond meal consists of bagel with almond butter and apple juice.
Intervention Type
Other
Intervention Name(s)
Bagel
Intervention Type
Other
Intervention Name(s)
Cream Cheese
Intervention Type
Other
Intervention Name(s)
Almond Butter
Primary Outcome Measure Information:
Title
Change in markers for glucose intolerance.
Description
After consuming the breakfast meal markers for glucose intolerance will be measured at the time points listed
Time Frame
0, .5, 1, 2, 3, 4, 5 hours following a meal
Secondary Outcome Measure Information:
Title
Change in metabolic markers
Description
After consuming the breakfast meal metabolic markers will be measured at the time points listed.
Time Frame
0, .5, 1, 2, 3, 4, 5 hours following a meal
Other Pre-specified Outcome Measures:
Title
Change in satiety markers
Description
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.
Time Frame
0, .5, 1, 2, 3, 4, 5 hours following a meal
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet C King, PhD
Organizational Affiliation
Children's Hospital & Research Institute Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Oakland Research Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women
We'll reach out to this number within 24 hrs