Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT02225951
Eligibility Criteria:
Inclusion Criteria:
1. Pregnant women, aged 18-40 years
2. 18.5 kg/m2 \< pre-pregnancy BMI \< 27.5 kg/m2 \[representing low to moderate risk category, adapted from WHO expert panel recommendation on BMI categories for determining public health and clinical action (REF: Lancet, 2004)\]
3. Singleton pregnancy
4. Newly GDM diagnosed women between 24 to (the latest) 32 weeks of gestation;
5. Diagnosed GDM according to either:
* World Health Organization (WHO) criteria if one or more glucose values equal to or exceed these threshold values \[75g Oral Glucose Tolerance Test: fasting 126 mg/dl; 2-h 140 mg/dl\] or
* American Diabetic Association (ADA) criteria if two or more glucose values equal to or exceed these threshold values \[100g Oral Glucose Tolerance Test: fasting 95 mg/dl; 1-h 180 mg/dl; 2-h 155 mg/dl, 3-h 140/dl\]
6. Willing and able to comply with the protocol
7. Signed informed consent
Exclusion Criteria:
1. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. constipation or diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy, galactosaemia, hyperemesis)
2. Currently on anti-diabetic therapy, for example on insulin or oral anti-diabetic medication
3. Already using a diabetes nutritional/dietary supplement (e.g. Glucerna®, Nutrient Diabetes®) within 4 weeks prior to signing informed consent
4. Known allergy or intolerance for any of the following ingredients; fish, milk, protein, lactose, fiber or soy
5. Any significant medical condition, other than GDM, that might interfere with the study or known to affect intra-uterine growth (e.g. Type 1 Diabetes, Type 2 Diabetes Mellitus, Crohn's disease, HIV/AIDS, liver disease, kidney disease etc.)
6. Currently or previously on special low/no carbohydrate diet (e.g. Atkin's diet) within 8 weeks prior to signing informed consent
7. Incapability to comply with study protocol or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
8. Participation in other studies involving investigational or marketed products concomitantly or within 4 weeks prior signing informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02225951
Study Brief:
Protocol Section:
NCT02225951