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

NCT04856800 | Completed

• 1 other identifier: 1-10-72-326-20
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (3)

• Maternal glycemic variability (GV)

  The Coefficient of Variation, power: n = 50

  24 hours

• Maternal glycemic variability (GV)

  Interquartile range (IQR), power n = 40

  24 hours

• Maternal glycemic variability (GV)

  Standard deviation (SD), power n = 18

  24 hours

Secondary Outcomes (69)

• 24 hours interstitial fluid glucose measures

  24 hours

• mean glucose

  24 hours

• maximum glucose

  24 hours

• Interstitial fluid glucose concentrations

  3 hours following breakfast

• Total energy expenditure

  24 hours

Study Arms (2)

Whey

EXPERIMENTAL

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.

Dietary Supplement: Whey

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Whey DIETARY_SUPPLEMENT

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

Whey

Placebo DIETARY_SUPPLEMENT

The placebo contains \<1 kcal and 0 g protein

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

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

Aarhus, Denmark

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Whey

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 23, 2021
• Study Start: December 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 12, 2023

Record last verified: 2022-05

Locations

DK (1)