Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: HMO; Dietary Supplement: Dextropur

• Registration Number: NCT02786160
• Lead Sponsor: Glycom A/S

Brief Summary

The study is a randomised, placebo-controlled, double-blind, parallel study in obese children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood obesity treatment program, will be included. The participating children will be randomised into one of three groups consuming either HMO (two groups) or placebo (one group).

The primary objective of the study is to establish the effects of HMOs on the faecal microbiota in children. Secondary objectives are to evaluate safety of HMO supplementation in children and the effect on gastrointestinal symptoms (tolerance), bowel habits, metabolic profile and body composition in obese children.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-30
• Status Verified: 2018-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Informed, written consent by the child's representative(s) and informed verbal assent by the child
2. Age ≥5 and <11 years at visit 0
3. BMI SDS of ≥ 2.3
4. Enrolment in the childhood obesity treatment program at the Children's Obesity Clinic
5. Ability and willingness to understand and comply with the study procedures
6. The child's representative(s) need(s) to read, speak and understand Danish

Exclusion Criteria

1. Participation in another clinical intervention study one month prior to the screening visit and throughout the study.
2. Any gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator.
3. Other severe disease(s) such as malignancy, kidney disease or neurological disease, as judged by the investigator.
4. Psychiatric disease, as judged by the investigator.
5. Use of probiotic supplements (yoghurt allowed) 3 months prior to screening and throughout the study.
6. Consumption of antibiotic drugs 3 months prior to screening and throughout the study.
7. Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) 2 weeks prior to screening and throughout the study.
8. Lack of suitability for participation in the study for any reason as judged by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMO1	HMO	Daily bolus of HMO1
HMO2	HMO	Daily bolus of HMO2
Dextropur	Dextropur	Daily bolus of Dextropur

Primary Outcome Measures

Name	Time	Method
Change from baseline in faecal microbiota profile	Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out

Secondary Outcome Measures

Name	Time	Method
Change from baseline of BMI-SDS	Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Change from baseline of waist circumference	Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Change from baseline of fat percentage	Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Change from baseline in gastrointestinal symptoms measured via the gastrointestinal symptom rating scale (GSRS)	Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Change from baseline in haematology	Baseline and after 8 weeks of intake, and after 10 months of wash-out
Change from baseline of specific faecal biomarkers related to inflammation	Baseline and after 8 weeks of intake, and after 10 months of wash-out
Change from baseline in clinical chemistry	Baseline and after 8 weeks of intake, and after 10 months of wash-out
Change from baseline in Bristol Stool Form Scale (BSFS)	Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Change from baseline of hip circumference	Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out
Change from baseline in specific host-bacteria metabolic biomarkers in blood	Baseline and after 8 weeks of intake, and after 10 months of wash-out
Change from baseline of specific blood biomarkers related to inflammation	Baseline and after 8 weeks of intake, and after 10 months of wash-out
Change from baseline of HOMA-IR	Baseline and after 8 weeks of intake, and after 10 months of wash-out
Change from baseline of specific blood biomarkers related to gut barrier function	Baseline and after 8 weeks of intake, and after 10 months of wash-out

Trial Locations

Locations (1)

Department of Paediatrics, Holbaek Hospital; 🇩🇰 Holbaek, Denmark