Acute Metabolic Effects of Pre-meal Consumption of Whey in Women at Risk of Gestational Diabetes Mellitus

Overview

The main objective of our study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared to placebo when consumed by women in risk of gestational diabetes mellitus (GMD) 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate any changes in substrate metabolism and energy expenditure using indirect calorimetry. Differences in hunger and satiety parameters as well as rate of gastric emptying will also be assessed. Furthermore, we will investigate the glucose response when the women consume the intervention at home in their own environment 30 minutes before breakfast in various doses (placebo, 10, 15, 20, 30 g whey). The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 2022

Interventions

  • Dietary Supplement: Whey
    • Doses of 10, 15, 20 and 30 gram protein of a regular whey protein compound (whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients))
  • Dietary Supplement: Placebo
    • The placebo contains <1 kcal and 0 g protein

Arms, Groups and Cohorts

  • Experimental: Whey
    • Whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients). The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast in the women’s own environment.
  • Placebo Comparator: Placebo
    • The placebo will be ingested 30 min. prior to an OGTT (3 hours). The placebo will also be ingested 30 min prior to breakfast in the women’s own environment.

Clinical Trial Outcome Measures

Primary Measures

  • Concentration differences in blood glucose following an OGTT
    • Time Frame: 3 hours following the OGTT

Secondary Measures

  • Concentration differences in glucose independent peptide (GIP)
    • Time Frame: 3 hours following the OGTT
  • Concentration differences in glucagon like peptide 1 (GLP-1)
    • Time Frame: 3 hours following the OGTT
  • Concentration differences in glucagon
    • Time Frame: 3 hours following the OGTT
  • Concentration differences in insulin
    • Time Frame: 3 hours following the OGTT
  • Concentration differences in c-peptide
    • Time Frame: 3 hours following the OGTT
  • Concentration differences in free fatty acids (FFA)
    • Time Frame: 3 hours following the OGTT
  • Concentration differences in ghrelin
    • Time Frame: 3 hours following the OGTT
  • Concentration differences in leptin
    • Time Frame: 3 hours following the OGTT
  • Concentration differences in amino acids (AA)
    • Time Frame: 3 hours following the OGTT
  • Gastric emptying rate (Concentration differences in blood paracetamol/acetaminophen)
    • Time Frame: 3 hours following the OGTT
  • Resting energy expenditure (REE) (Resting Metabolic Rate)
    • Time Frame: 3 hours following the OGTT
  • Respiratory quotient (RQ)
    • Time Frame: 3 hours following the OGTT
  • Self-reported appetite
    • Time Frame: 3 hours following the OGTT and 3 hours following breakfast
    • A visual analogue scale ranging from “not at all” to “extremely” will be used to assess Hunger, Fullness, Satiety, Desire, Prospective consumption (Quantity).
  • Heart rate
    • Time Frame: 5 days
    • A combined accelerometer and heart rate monitor will be used to measure heart rate (beats/minute)
  • Energy expenditure
    • Time Frame: 5 days
    • A combined accelerometer and heart rate monitor will be used to estimate energy expenditure (kCal)
  • Activity
    • Time Frame: 5 days
    • A combined accelerometer and heart rate monitor will be used to measure activity (counts/minute)
  • Continuous glucose measurements (CGM)
    • Time Frame: 5 days
    • Time in range, concentration differences in interstitial fluid glucose 3 hours following breakfast, glycemic variability, mean glucose, daily maximum glucose, estimated HbA1c

Participating in This Clinical Trial

Inclusion Criteria

  • Referred to screening for Gestational Diabetes Mellitus by week 24-28 – BMI 20-35 – 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 – Celiac disease – Medication with effect on glucose metabolism e.g. steroid – Do not speak or understand Danish – Gemelli – Polycystic Ovarian Syndrome – PI finds the patient unfit (like mental illness, too nervous or other) – Anemia (hemoglobin <6 mmol/l) – Severe chronic illness – Depression – Severe nausea/vomiting – Non-breakfast eaters

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Per G Ovesen, Professor, Study Director, Institute of Clinical Medicine, Aarhus University and Department of Gynecology and Obstetrics and Steno Diabetes Center Aarhus, Aarhus University Hospital
  • Overall Contact(s)
    • Stine Smedegaard, MD, 20714671, stinesmedegaard@clin.au.dk

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