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Completed

NCT Number: NCT04578431

Artificial Sweeteners in Breast Milk

This study will investigate how some artificial sweeteners (AS) cross from blood to breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic status (diabetes). This will be investigated through a clinical trial in which 60 women divided into three groups (normal weight, overweight and diabetic) will drink a beverage containing four AS. over a period of six hours the women will donate blood and breast milk samples in order to investigate the presence of AS.

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Key information

Conditions

Breastfeeding Behavior Body Weight Breast Feeding Diabetes Mellitus Endocrine System Diseases Feeding Behavior Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Above 18 years old
  • Able to give consent
  • Able to produce enough amounts of breastmilk
  • Danish/English speakers
  • Pre-pregnancy BMI below 25 (20 subjects)
  • Pre-pregnancy BMI above 27 (20 subjects)
  • Diabetes type 1 or 2 (20 subjects)

Exclusion criteria

  • Under the age of 18 years old
  • Unable to give consent
  • Unable to produce enough amounts of breastmilk
  • Non-Danish/English speakers
  • If they have consumed artificial sweeteners 24 hours prior to trial

Treatment and study plan

Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)

Dietary Supplement

The intervention is found in light products ingested by millions of people on a daily basis worldwide

Primary outcomes

  1. Breastmilk from mother

    Time frame: Baseline, after 30 mins and afterwards once and hour for six hours

    Concentration of artificial sweeteners in mother's breast milk

  2. Blood from mother

    Time frame: Baseline, after 30 mins and afterwards once and hour for six hours

    Concentration of artificial sweeteners in mother's blood

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Artificial Sweeteners in Breast Milk: A Clinical Investigation With a Kinetic Perspective

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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