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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.
The two study days in the laboratory will be repeated 3-9 months after pregnancy. The purpose of this is to be able to compare the metabolic response of pre-meal whey during pregnancy with the response in a not-pregnant state. The study days at home will not be repeated after pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey | Dietary Supplement | 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)) |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration differences in blood glucose following an OGTT | 3 hours following the OGTT |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration differences in glucose independent peptide (GIP) | 3 hours following the OGTT | |
| Concentration differences in glucagon like peptide 1 (GLP-1) | 3 hours following the OGTT | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per G Ovesen, Professor | Institute of Clinical Medicine, Aarhus University and Department of Gynecology and Obstetrics and Steno Diabetes Center Aarhus, Aarhus University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital | Aarhus | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41203981 | Derived | Smedegaard S, Rittig N, Ovesen PG, Suder LB, Knudsen JH, Brunsgaard LH, Kampmann U. Once-daily supplementation with pre-meal whey protein lowers breakfast postprandial glucose levels in women with GDM throughout the third trimester: a randomised, controlled, clinical trial. Diabetologia. 2026 Feb;69(2):350-363. doi: 10.1007/s00125-025-06587-0. Epub 2025 Nov 7. |
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| ID | Term |
|---|---|
| D000067796 | Whey |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Singleblind, randomized, crossover design
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Participants will be blinded to the intervention and placebo in the laboratory setting.
Quadruple (Participants, care providers, investigators and outcome assessors) Participants, care providers, investigators and outcome assessors will be blinded to the placebo and varying doses of whey in the home setting.
| Placebo | Dietary Supplement | The placebo contains <1 kcal and 0 g protein |
|
| Concentration differences in glucagon |
| 3 hours following the OGTT |
| Concentration differences in insulin | 3 hours following the OGTT |
| Concentration differences in c-peptide | 3 hours following the OGTT |
| Concentration differences in free fatty acids (FFA) | 3 hours following the OGTT |
| Concentration differences in ghrelin | 3 hours following the OGTT |
| Concentration differences in leptin | 3 hours following the OGTT |
| Concentration differences in amino acids (AA) | 3 hours following the OGTT |
| Gastric emptying rate (Concentration differences in blood paracetamol/acetaminophen) | 3 hours following the OGTT |
| Resting energy expenditure (REE) (Resting Metabolic Rate) | 3 hours following the OGTT |
| Respiratory quotient (RQ) | 3 hours following the OGTT |
| Self-reported appetite | A visual analogue scale ranging from "not at all" to "extremely" will be used to assess Hunger, Fullness, Satiety, Desire, Prospective consumption (Quantity). | 3 hours following the OGTT and 3 hours following breakfast |
| Heart rate | A combined accelerometer and heart rate monitor will be used to measure heart rate (beats/minute) | 5 days |
| Energy expenditure | A combined accelerometer and heart rate monitor will be used to estimate energy expenditure (kCal) | 5 days |
| Activity | A combined accelerometer and heart rate monitor will be used to measure activity (counts/minute) | 5 days |
| Continuous glucose measurements (CGM) | Time in range, concentration differences in interstitial fluid glucose 3 hours following breakfast, glycemic variability, mean glucose, daily maximum glucose, estimated HbA1c | 5 days |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |