Diabetes, GestationalNCT01919476
Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women
A study testing Bagel, Cream Cheese and Almond Butter in people with Diabetes, Gestational, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- Bagel, Cream Cheese and Almond Butter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant Hispanic women
- Between 30 and 36 weeks gestation
- Prepregnancy BMI between 25 and 40
Who cannot join
- Diagnosis of gestational diabetes mellitus
- Preexisting diabetes mellitus
- Renal disease
- Thyroid disease
- Cardiovascular disease
- History of drug abuse
- Nut allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Oakland Research Institute
Oakland, California, 94609
About this study
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
- Being tested
- Bagel, Cream Cheese, Almond Butter
- Keywords
- Postprandial, Insulin resistance, Lipids, Satiety, Almonds
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BagelOther
Cream CheeseOther
Almond ButterOther
| Study group | Role | What they receive |
|---|---|---|
| Control Meal: Bagel, cream cheese | Active comparator | Control meal consists of bagel with cream cheese and apple juice. Receives: Other: Bagel; Other: Cream Cheese |
| Almond Meal: Bagel, almond butter | Experimental | Almond meal consists of bagel with almond butter and apple juice. Receives: Other: Bagel; Other: Almond Butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in markers for glucose intolerance.
After consuming the breakfast meal markers for glucose intolerance will be measured at the time points listed
Measured: 0, .5, 1, 2, 3, 4, 5 hours following a meal
Secondary outcomes (1)
Change in metabolic markers
After consuming the breakfast meal metabolic markers will be measured at the time points listed.
Measured: 0, .5, 1, 2, 3, 4, 5 hours following a meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startSep 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet C King, PhD, Principal investigator, Children's Hospital & Research Institute Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919476
- Sponsor's protocol ID
- CHO17-ABC
- Status last verified
- Nov 2020
- First submitted
- 31 Jul 2013
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women
- ClinicalTrials.gov ID
- NCT01919476
- Acronym / sponsor ID
- CHO17-ABC
- Conditions
- Diabetes, Gestational
- Keywords
- Postprandial, Insulin resistance, Lipids, Satiety, Almonds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Meal: Bagel, cream cheese | Active comparator | Other: Bagel, Other: Cream CheeseControl meal consists of bagel with cream cheese and apple juice. |
| Almond Meal: Bagel, almond butter | Experimental | Other: Bagel, Other: Almond ButterAlmond meal consists of bagel with almond butter and apple juice. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant Hispanic women
- Between 30 and 36 weeks gestation
- Prepregnancy BMI between 25 and 40
Key exclusion criteria (7 listed)
- Diagnosis of gestational diabetes mellitus
- Preexisting diabetes mellitus
- Renal disease
- Thyroid disease
- Cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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
1 secondary outcome
Change in metabolic markers
Time frame: 0, .5, 1, 2, 3, 4, 5 hours following a meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet C King, PhD principal investigator
Children's Hospital & Research Institute Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bagel, Cream Cheese and Almond Butter in people with Diabetes, Gestational, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in markers for glucose intolerance. (time frame: 0, .5, 1, 2, 3, 4, 5 hours following a meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.