Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 54 for:    barley

Dietary Management of Gestational Diabetes (eMOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03681054
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
Helsinki University
Aalto University
National Institute for Health and Welfare, Finland
City of Helsinki
UKK Institute
Information provided by (Responsible Party):
Saila Koivusalo, Helsinki University Central Hospital

Brief Summary:
eMOM is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. The comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. The recruited women (n=60) have been diagnosed with gestational diabetes mellitus, and are of Caucasian origin. Of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy Nordic foods. The study has two two-week study periods that are carried out on approximately gestational weeks 24-28 (period I) and 34-36 (period II). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. At the beginning of the study, before study period I, the participants are randomized to either one of the intervention diets. The first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. After the wash-out period, the participants receive three days' worth of food according to the other diet. After the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. To ensure the diet is followed, the participants gets at least three personal face-to-face counseling sessions, phone calls, mobile reminders, recipes and food items. After delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.

Condition or disease Intervention/treatment Phase
Diabetes, Gestational Dietary Modification Glucose Intolerance During Pregnancy Body Composition Birth Weight Other: Carbohydrate restricted diet Other: Plant-protein based diet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Guided Dietary Patterns on Metabolic Outcomes in Overweight Pregnant Women With Gestational Diabetes and on Offspring Body Composition
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Carbohydrate restricted diet
Dietary intervention: moderately carbohydrate restricted diet. Parallel phase starts after study period I and the diet is followed until labor.
Other: Carbohydrate restricted diet
The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 500 g/d, fish 2 times/wk, low-fat instead of high-fat meat, red meat ≤ 3 times/wk, low-fat instead of high-fat dairy, high-fibre instead of low-fibre grains, vegetable oils (excluding palm oil and coconut oil) and soft margarine instead of animal fats, moderate reduction of carbohydrates (targets for macronutrients: carbohydrates 40 E%; fat 40 E%; protein 20 E%; dietary fiber 32g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: <10 E%; fatty acids: saturated fatty acids < 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)

Experimental: Plant-protein based diet
Dietary intervention: plant-protein based diet, en emphasis on healthy Nordic foods. Parallel phase starts after study period I and the diet is followed until labor.
Other: Plant-protein based diet
The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 1 kg/d; fish 3/wk; high-fibre grains, mainly rye, oat and barley; plant protein instead of meat protein; low-fat fermented dairy instead of other dairy; rapeseed oil and rapeseed-based margarine instead of other fats; no carbohydrate restriction (targets for macronutrients: carbohydrates 50 E%; fat 30 E%; protein 20 E%; dietary fiber 36g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: <10 E%; fatty acids: saturated fatty acids < 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)




Primary Outcome Measures :
  1. Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) in cross-over phase [ Time Frame: Study period I: during a 3 day intervention-diet period within gestational weeks 24-28 ]
    Measured with FreeStyle®Libre, Continuous Glucose Monitoring system

  2. Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) [ Time Frame: Study period II: during a 14 day period within gestational weeks 34-36 ]
    Measured with FreeStyle®Libre, Continuous Glucose Monitoring system

  3. Child: Neonatal body fat% [ Time Frame: one measure within 0-2 days after birth of the child ]
    Neonatal body fat%; Measured with PEA POD Cosmed® Infant Body Composition Assessment system


Secondary Outcome Measures :
  1. Mother: Glycaemic variability in crossover phase [ Time Frame: Study period I: during a 3 day intervention-diet period within gestational weeks 24-28 ]
    Measured with FreeStyle®Libre, Continuous Glucose Monitoring system

  2. Mother: Glycaemic variability [ Time Frame: Study period II: during a 14 day period within gestational weeks 34-36 ]
    Measured with FreeStyle®Libre, Continuous Glucose Monitoring system

  3. Percentage of participants on GDM medication [ Time Frame: Up to 42 gestational weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Gestational diabetes at enrollment

Exclusion Criteria:

  • Gestational weeks exceed 28+6
  • Multiple pregnancy
  • Food allergies or restrictions (other than lactose intolerance)
  • Mother's or father's ethnic background other than Caucasian
  • Type 1 or type 2 diabetes
  • Medication which affects glucose metabolism
  • Cholesterol medication
  • Drug or alcohol abuse
  • Psychiatric illness which affects participation in the study
  • Factors hampering communication (e.g. lack of Finnish skills)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681054


Contacts
Layout table for location contacts
Contact: Saila B Koivusalo, MD, PhD +358407250620 saila.koivusalo@helsinki.fi
Contact: Jelena Meinilä, PhD +358407558356 jelena.meinila@helsinki.fi

Locations
Layout table for location information
Finland
Helsinki university central hospital Recruiting
Helsinki, Finland
Contact: Rhea Paajanen         
Sponsors and Collaborators
Helsinki University Central Hospital
Helsinki University
Aalto University
National Institute for Health and Welfare, Finland
City of Helsinki
UKK Institute
Investigators
Layout table for investigator information
Study Director: Seppo Heinonen, prof Head of department of obs and gyn/Helsinki University Hospital

Layout table for additonal information
Responsible Party: Saila Koivusalo, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03681054     History of Changes
Other Study ID Numbers: HUS/1792/2016_2
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Saila Koivusalo, Helsinki University Central Hospital:
Nutrition
Dietary Counseling
Diet
Pregnancy

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes, Gestational
Birth Weight
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Body Weight
Signs and Symptoms
Hyperglycemia