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

NCT ID: NCT04767880

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2023-09-29

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes Mellitus in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Singleblind, randomized, crossover design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Whey

Intervention Type 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))

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

The placebo contains \<1 kcal and 0 g protein

Interventions

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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))

Intervention Type DIETARY_SUPPLEMENT

Placebo

The placebo contains \<1 kcal and 0 g protein

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Referred to screening for Gestational Diabetes Mellitus by week 24-30 or GDM
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per G Ovesen, Professor

Role: STUDY_DIRECTOR

Institute of Clinical Medicine, Aarhus University and Department of Gynecology and Obstetrics and Steno Diabetes Center Aarhus, Aarhus University Hospital

Locations

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

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-10-72-305-20

Identifier Type: -

Identifier Source: org_study_id