Artificial Sweeteners in Breast Milk

NCT ID: NCT04578431

Last Updated: 2022-11-02

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

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breastfeeding Diabetes Mellitus Overweight

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

All participants are given the same intervention and are aware of this

Study Groups

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Intervention groups

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AS0063221

Identifier Type: -

Identifier Source: org_study_id

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