MedDataX Logo

Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery

NCT ID: NCT04856800

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main objective of the study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared with placebo when consumed by women with gestational diabetes mellitus (GDM) from diagnosis (around gestational week 28) to delivery. Any changes in substrate metabolism and energy expenditure using indirect calorimetry will also be investigated. Differences in hunger and satiety parameters as well as blood pressure and gestational weight gain will also be assessed. Furthermore, analysis on the glucose response when the women consume the intervention (whey or placebo) at home in their own environment 30 minutes before breakfast at time of diagnosis (earliest week 28) and week 36 (four days following each time point) will be made. The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided for two days following the study days in the laboratory. At delivery cord blood will be sampled for analysis on metabolic parameters and investigations on epigenetics/DNA methylations. Complications to the delivery, neonatal outcomes, anthropometrics of the child will also be assessed. Breast milk composition will also be analyzed.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Whey

Whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients). 20 g of whey protein will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery.

Group Type EXPERIMENTAL

Whey

Intervention Type DIETARY_SUPPLEMENT

20 g protein of whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients)

Placebo

The placebo will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

The placebo contains \<1 kcal and 0 g protein

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whey

20 g protein of whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients)

Intervention Type DIETARY_SUPPLEMENT

Placebo

The placebo contains \<1 kcal and 0 g protein

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* GDM (OGTT level of blood glucose ≥ 9 mmol/L)
* Normal blood pressure
* Age \> 18 years

Exclusion Criteria

* Special dietary regimes \> 1 month at time of inclusion e.g. ketogenic diet
* Daily intake of protein supplements
* Milk allergy or phenylketonuria
* Medication with effect on glucose metabolism e.g. steroids
* Do not speak or understand Danish
* Twin pregnancy
* PCOS
* PI finds the patient unfit (like mental illness, too nervous or other)
* Severe chronic illness
* Severe nausea/vomiting
* Non-breakfast eaters
* Celiac disease

The initiation of insulin treatment during the trial will not lead to exclusion from the trial.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital

Aarhus, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1-10-72-326-20

Identifier Type: -

Identifier Source: org_study_id