Artificial Sweeteners in Breast Milk

NCT04578431 | Completed DMC

• 1 other identifier: AS0063221
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding; Diabetes Mellitus; Overweight

Keywords

Artificial sweeteners; Non-nutritive sweeteners

Outcome Measures

Primary Outcomes (2)

• Breastmilk from mother

  Concentration of artificial sweeteners in mother's breast milk

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

• Blood from mother

  Concentration of artificial sweeteners in mother's blood

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

Study Arms (1)

Intervention groups

EXPERIMENTAL

The participants will be given a beverage containing four artificial sweeteners (intervention) at baseline

Dietary Supplement: Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)

Interventions

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

Intervention groups

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Breast Feeding; Diabetes Mellitus; Overweight

Interventions

Sweetening Agents; acetosulfame; trichlorosucrose; Cyclamates

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants are given the same intervention and are aware of this
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 60 women will be divided into three groups (n=20 each) based on pre-pregnancy BMI and metabolic status. The groups are 1. Normal weight (BMI \< 25), 2. Over weight (BMI \> 27), 3. Diabetic

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: November 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 2, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)