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Human Milk Oligossaccharide and Acetate Production in Vivo

Primary Purpose

Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Human Milk Oligossaccharide
Maltodextrin
Human Milk Oligossaccharide and resistant starch
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion criteria:

Lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2) healthy men aged 30 - 65 years

as well as

overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2) prediabetic men aged between 30 - 65 years

Exclusion criteria:

  • Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L and 2h glucose ≥ 11.1 mmol/L)
  • Gastroenterological diseases or abdominal surgery;
  • Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
  • Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day;
  • Plans to lose weight or following of a hypocaloric diet;
  • Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
  • Intensive exercise training more than three hours a week;
  • Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
  • Regular use of laxation products;
  • Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
  • Follow a vegan diet.

Sites / Locations

  • Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

Human milk-like oligosaccharide alone

Human milk-like oligosaccharide and resistant starch

Arm Description

11.43 g (3 x 3.81 g) maltodextrin the day before the clinical investigation day

12 g (3 x 4 g) of the human milk-like oligosaccharide the day before the clinical investigation day

12 g (3 x 4 g) of the human milk-like oligosaccharide and 7.5g resistant starch (3 x 2.5 g) the day before the clinical investigation day

Outcomes

Primary Outcome Measures

Plasma acetate concentrations.
During the clinical investigation day plasma acetate will be sampled
Plasma acetate concentrations.
During the clinical investigation day plasma acetate will be sampled
Plasma acetate concentrations.
During the clinical investigation day plasma acetate will be sampled
Plasma acetate concentrations.
During the clinical investigation day plasma acetate will be sampled
Faecal acetate concentrations.
On the day of clinical investigation day, fecal acetate will be sampled
Plasma butyrate concentrations.
During the clinical investigation day, plasma butyrate will be sampled
Plasma butyrate concentrations.
During the clinical investigation day, plasma butyrate will be sampled
Plasma butyrate concentrations.
During the clinical investigation day, plasma butyrate will be sampled
Plasma butyrate concentrations.
During the clinical investigation day, plasma butyrate will be sampled
Fecal butyrate concentrations.
On the day of clinical investigation day, fecal butyrate will be sampled
Plasma propionate concentrations.
During the clinical investigation day, plasma propionate will be sampled
Plasma propionate concentrations.
During the clinical investigation day, plasma propionate will be sampled
Plasma propionate concentrations.
During the clinical investigation day, plasma propionate will be sampled
Plasma propionate concentrations.
During the clinical investigation day, plasma propionate will be sampled
Faecal propionate concentrations.
On the day of clinical investigation day, fecal propionate will be sampled

Secondary Outcome Measures

Energy expenditure, fat and carbohydrate oxidation
Energy expenditure, fat and carbohydrate oxidation will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands);
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).
Plasma glucose concentrations
Plasma glucose concentrations
Plasma insulin concentrations
Plasma insulin concentrations
Plasma FFA concentrations
Plasma FFA concentrations
Faecal microbiota composition
Faecal microbiota composition will be assessed via16S rRNA gene sequencing

Full Information

First Posted
December 4, 2020
Last Updated
November 2, 2021
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04795804
Brief Title
Human Milk Oligossaccharide and Acetate Production in Vivo
Official Title
The Effects of Human-like Milk Oligosaccharide and Resistant Starch on Acetate Production and Human Substrate Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study investigators hypothesize (1) that the SCFA/acetate metabolism differs between metabolic phenotypes and (2) that using a mixture of fibres that differ in degree of polymerization and branching namely a resistant starch and a human-like milk oligosaccharide enhance the acetate availability in the distal colon and systemic circulation, consequently leading to its metabolic effects. To study this, the investigators will supplement lean, normoglycaemic vs. overweight/obese, prediabetic men with the fibre mixture the day before the clinical investigation day (CID) and study during the CID its effects on fasting and postprandial substrate and energy metabolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
11.43 g (3 x 3.81 g) maltodextrin the day before the clinical investigation day
Arm Title
Human milk-like oligosaccharide alone
Arm Type
Active Comparator
Arm Description
12 g (3 x 4 g) of the human milk-like oligosaccharide the day before the clinical investigation day
Arm Title
Human milk-like oligosaccharide and resistant starch
Arm Type
Experimental
Arm Description
12 g (3 x 4 g) of the human milk-like oligosaccharide and 7.5g resistant starch (3 x 2.5 g) the day before the clinical investigation day
Intervention Type
Dietary Supplement
Intervention Name(s)
Human Milk Oligossaccharide
Intervention Description
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Intervention Type
Dietary Supplement
Intervention Name(s)
Human Milk Oligossaccharide and resistant starch
Intervention Description
The day before the CIDs, the participants receive the supplements 3x a day in randomized order
Primary Outcome Measure Information:
Title
Plasma acetate concentrations.
Description
During the clinical investigation day plasma acetate will be sampled
Time Frame
plasma acetate will be sampled during the CID before the consumption of a liquid high fat mixed meal
Title
Plasma acetate concentrations.
Description
During the clinical investigation day plasma acetate will be sampled
Time Frame
plasma acetate will be sampled during the CID at t=60 minutes after consumption of a liquid high fat mixed meal
Title
Plasma acetate concentrations.
Description
During the clinical investigation day plasma acetate will be sampled
Time Frame
plasma acetate will be sampled during the CID at t=120 minutes after consumption of a liquid high fat mixed meal
Title
Plasma acetate concentrations.
Description
During the clinical investigation day plasma acetate will be sampled
Time Frame
plasma acetate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal
Title
Faecal acetate concentrations.
Description
On the day of clinical investigation day, fecal acetate will be sampled
Time Frame
Fecal acetate will be sampled in the morning before the testday
Title
Plasma butyrate concentrations.
Description
During the clinical investigation day, plasma butyrate will be sampled
Time Frame
plasma butyrate will be sampled during the CID before the consumption of a liquid high fat mixed meal
Title
Plasma butyrate concentrations.
Description
During the clinical investigation day, plasma butyrate will be sampled
Time Frame
plasma butyrate will be sampled during the CID at t=60 after consumption of a liquid high fat mixed meal
Title
Plasma butyrate concentrations.
Description
During the clinical investigation day, plasma butyrate will be sampled
Time Frame
plasma butyrate will be sampled during the CID at t=120 after consumption of a liquid high fat mixed meal
Title
Plasma butyrate concentrations.
Description
During the clinical investigation day, plasma butyrate will be sampled
Time Frame
plasma butyrate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal
Title
Fecal butyrate concentrations.
Description
On the day of clinical investigation day, fecal butyrate will be sampled
Time Frame
Fecal butyrate will be sampled in the morning before the testday
Title
Plasma propionate concentrations.
Description
During the clinical investigation day, plasma propionate will be sampled
Time Frame
Plasma propionate will be sampled during the CID before the consumption of a liquid high fat mixed meal
Title
Plasma propionate concentrations.
Description
During the clinical investigation day, plasma propionate will be sampled
Time Frame
Plasma propionate will be sampled during the CID t=60 minutes after the consumption of a liquid high fat mixed meal
Title
Plasma propionate concentrations.
Description
During the clinical investigation day, plasma propionate will be sampled
Time Frame
Plasma propionate will be sampled during the CID t=120 minutes after the consumption of a liquid high fat mixed meal
Title
Plasma propionate concentrations.
Description
During the clinical investigation day, plasma propionate will be sampled
Time Frame
Plasma propionate will be sampled during the CID t=240 minutes after the consumption of a liquid high fat mixed meal
Title
Faecal propionate concentrations.
Description
On the day of clinical investigation day, fecal propionate will be sampled
Time Frame
Fecal propionate will be sampled in the morning before the testday
Secondary Outcome Measure Information:
Title
Energy expenditure, fat and carbohydrate oxidation
Description
Energy expenditure, fat and carbohydrate oxidation will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands);
Time Frame
Indirect calorimetry will be measured before and for 4 hours after the consumption of the liquid high-fat mixed meal during the whole CID
Title
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).
Description
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).
Time Frame
Breath H2 will be sampled during the CID before and at t=30, t=60, t=90, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal
Title
Plasma glucose concentrations
Description
Plasma glucose concentrations
Time Frame
Plasma glucose concentrations will be sampled during the CID before and t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal
Title
Plasma insulin concentrations
Description
Plasma insulin concentrations
Time Frame
Plasma insulin concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal
Title
Plasma FFA concentrations
Description
Plasma FFA concentrations
Time Frame
Plasma FFA concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal
Title
Faecal microbiota composition
Description
Faecal microbiota composition will be assessed via16S rRNA gene sequencing
Time Frame
Faecal microbiota composition will be sampled in the morning before the testday

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2) healthy men aged 30 - 65 years as well as overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2) prediabetic men aged between 30 - 65 years Exclusion criteria: Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L and 2h glucose ≥ 11.1 mmol/L) Gastroenterological diseases or abdominal surgery; Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years; Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day; Plans to lose weight or following of a hypocaloric diet; Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study; Intensive exercise training more than three hours a week; Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs); Regular use of laxation products; Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition). Follow a vegan diet.
Facility Information:
Facility Name
Maastricht University
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
5229ER
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Human Milk Oligossaccharide and Acetate Production in Vivo

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