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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03232762
Other study ID # 17-00694
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 3, 2017
Est. completion date August 22, 2019

Study information

Verified date November 2019
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 specified outcomes because the proportions of macronutrients are significant. The primary objective is to detect differences in weight gain.


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.


Recruitment information / eligibility

Status Completed
Enrollment 303
Est. completion date August 22, 2019
Est. primary completion date August 22, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- All normal pregnant patients who will be more than three months from term

Exclusion Criteria:

- Illness making it a high risk pregnancy

- Chronic renal disease

- Malignancy

- Congestive heart failure

- Diabetes

- Hypertension

Study Design


Intervention

Dietary Supplement:
Refined Grains
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 Grains
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.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in weight gain 6 Months
Secondary Pre-Term Birth Rate 6 Months
Secondary Neonatal Weight 6 Months
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