Pregnancy RelatedNCT03232762
Effects of Diet on Pregnancy Outcome and Child Obesity
A study testing Refined Grains and Whole Grains in people with Pregnancy Related and Diet Modification, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of the study is to compare 3 different diets in pregnancy, equal in calories, and fats, different in refined grains compared to whole grains as a source of carbohydrates, and in calories from carbohydrate, compared to protein as a source of calories.The hypothesis is that there will be differences in the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Diet Modification, Obesity
- What is being tested?
- Refined Grains and Whole Grains
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2017to 22 Aug 2019
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All normal pregnant patients who will be more than three months from term
Who cannot join
- Illness making it a high risk pregnancy
- Chronic renal disease
- Malignancy
- Congestive heart failure
- Diabetes
- Hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The purpose of the study is to compare 3 different diets in pregnancy, equal in calories, and fats, different in refined grains compared to whole grains as a source of carbohydrates, and in calories from carbohydrate, compared to protein as a source of calories.The hypothesis is that there will be differences in the specified outcomes because the proportions of macronutrients are significant. The primary objective is to detect differences in weight gain.
Read the detailed description
There will be randomized sequential assignment of pregnant women at the initial clinic visit to Diet A, a high proportion of calories from refined grains as a carbohydrate source, and Diet B, a high proportion of calories from whole grains. Random number assignment is impractical for counseling purposes and blinding not possible. Therefore, randomization by diet assignment by day of initial visit via random number was chosen. If the random number is odd Diet A would be selected, if the random number is even Diet B will be selected for that day.
- Conditions
- Pregnancy Related, Diet Modification, Obesity, Hypertension, Pre-Eclampsia, Blood Pressure
- Being tested
- Refined Grains, Whole Grains
- Medical subject headings
- Obesity, Hypertension, Pre-Eclampsia, Breast Feeding, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refined GrainsDietary supplement
In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.
Whole GrainsDietary supplement
In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.
| Study group | Role | What they receive |
|---|---|---|
| Diet A | Active comparator | high proportion of calories from refined grains as a carbohydrate source Receives: Dietary Supplement: Refined Grains |
| Diet B | Active comparator | a high proportion of calories from whole grains Receives: Dietary Supplement: Whole Grains |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in weight gain
Measured: 6 Months
Secondary outcomes (2)
Pre-Term Birth Rate
Measured: 6 Months
Neonatal Weight
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start3 Oct 2017
- Primary completion22 Aug 2019
- Study completion22 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce Young, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232762
- Sponsor's protocol ID
- 17-00694
- Status last verified
- Nov 2019
- First submitted
- 25 Jul 2017
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun H, Yamada P, Paetow A, Chan M, Arslan A, Landberg R, Dominguez-Bello MG, Young BK. A randomized controlled trial of the effects of whole grains versus refined grains diets on the microbiome in pregnancy. Sci Rep. 2022 May 7;12(1):7509. doi: 10.1038/s41598-022-11571-4.
PubMed 35525865
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diet on Pregnancy Outcome and Child Obesity
- ClinicalTrials.gov ID
- NCT03232762
- Acronym / sponsor ID
- 17-00694
- Conditions
- Pregnancy Related, Diet Modification, Obesity, Hypertension, Pre-Eclampsia, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 28 Jul 2017 (actual)
- 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.
The purpose of the study is to compare 3 different diets in pregnancy, equal in calories, and fats, different in refined grains compared to whole grains as a source of carbohydrates, and in calories from carbohydrate, compared to protein as a source of calories.The hypothesis is that there will be differences in the specified outcomes because the proportions of macronutrients are significant. The primary objective is to detect differences in weight gain.
Detailed description
There will be randomized sequential assignment of pregnant women at the initial clinic visit to Diet A, a high proportion of calories from refined grains as a carbohydrate source, and Diet B, a high proportion of calories from whole grains. Random number assignment is impractical for counseling purposes and blinding not possible. Therefore, randomization by diet assignment by day of initial visit via random number was chosen. If the random number is odd Diet A would be selected, if the random number is even Diet B will be selected for that day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet A | Active comparator | Dietary Supplement: Refined Grainshigh proportion of calories from refined grains as a carbohydrate source |
| Diet B | Active comparator | Dietary Supplement: Whole Grainsa high proportion of calories from whole grains |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All normal pregnant patients who will be more than three months from term
Key exclusion criteria (6 listed)
- Illness making it a high risk pregnancy
- Chronic renal disease
- Malignancy
- Congestive heart failure
- Diabetes
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 |
|---|---|---|
| Refined GrainsIn week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance. | Dietary supplement | Diet A |
| Whole GrainsIn week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance. | Dietary supplement | Diet B |
Primary outcome
Differences in weight gain
Time frame: 6 Months
2 secondary outcomes
Pre-Term Birth Rate
Time frame: 6 Months
Neonatal Weight
Time frame: 6 Months
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 13 Nov 2019.
- Derived from this study: PubMed 35525865Sun H, Yamada P, Paetow A, Chan M, Arslan A, Landberg R, Dominguez-Bello MG, Young BK. A randomized controlled trial of the effects of whole grains versus refined grains diets on the microbiome in pregnancy. Sci Rep. 2022 May 7;12(1):7509. doi: 10.1038/s41598-022-11571-4.
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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.
Bruce Young, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Refined Grains and Whole Grains in people with Pregnancy Related and Diet Modification, run by NYU Langone Health 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 1 inclusion and 6 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 13 Nov 2019. 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?
Differences in weight gain (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03232762, which also lists 1 linked publication.
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 13 Nov 2019.