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Completed

NCT Number: NCT04795804

Human Milk Oligossaccharide and Acetate Production in Vivo

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 5229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Human Milk Oligossaccharide

Dietary Supplement

The day before the CIDs, the participants receive the supplements 3x a day in randomized order

Maltodextrin

Dietary Supplement

The day before the CIDs, the participants receive the supplements 3x a day in randomized order

Human Milk Oligossaccharide and resistant starch

Dietary Supplement

The day before the CIDs, the participants receive the supplements 3x a day in randomized order

Primary outcomes

  1. Plasma acetate concentrations.

    Time frame: plasma acetate will be sampled during the CID before the consumption of a liquid high fat mixed meal

    During the clinical investigation day plasma acetate will be sampled

  2. Plasma acetate concentrations.

    Time frame: plasma acetate will be sampled during the CID at t=60 minutes after consumption of a liquid high fat mixed meal

    During the clinical investigation day plasma acetate will be sampled

  3. Plasma acetate concentrations.

    Time frame: plasma acetate will be sampled during the CID at t=120 minutes after consumption of a liquid high fat mixed meal

    During the clinical investigation day plasma acetate will be sampled

  4. Plasma acetate concentrations.

    Time frame: plasma acetate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal

    During the clinical investigation day plasma acetate will be sampled

  5. Faecal acetate concentrations.

    Time frame: Fecal acetate will be sampled in the morning before the testday

    On the day of clinical investigation day, fecal acetate will be sampled

  6. Plasma butyrate concentrations.

    Time frame: plasma butyrate will be sampled during the CID before the consumption of a liquid high fat mixed meal

    During the clinical investigation day, plasma butyrate will be sampled

  7. Plasma butyrate concentrations.

    Time frame: plasma butyrate will be sampled during the CID at t=60 after consumption of a liquid high fat mixed meal

    During the clinical investigation day, plasma butyrate will be sampled

  8. Plasma butyrate concentrations.

    Time frame: plasma butyrate will be sampled during the CID at t=120 after consumption of a liquid high fat mixed meal

    During the clinical investigation day, plasma butyrate will be sampled

  9. Plasma butyrate concentrations.

    Time frame: plasma butyrate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal

    During the clinical investigation day, plasma butyrate will be sampled

  10. Fecal butyrate concentrations.

    Time frame: Fecal butyrate will be sampled in the morning before the testday

    On the day of clinical investigation day, fecal butyrate will be sampled

  11. Plasma propionate concentrations.

    Time frame: Plasma propionate will be sampled during the CID before the consumption of a liquid high fat mixed meal

    During the clinical investigation day, plasma propionate will be sampled

  12. Plasma propionate concentrations.

    Time frame: Plasma propionate will be sampled during the CID t=60 minutes after the consumption of a liquid high fat mixed meal

    During the clinical investigation day, plasma propionate will be sampled

  13. Plasma propionate concentrations.

    Time frame: Plasma propionate will be sampled during the CID t=120 minutes after the consumption of a liquid high fat mixed meal

    During the clinical investigation day, plasma propionate will be sampled

  14. Plasma propionate concentrations.

    Time frame: Plasma propionate will be sampled during the CID t=240 minutes after the consumption of a liquid high fat mixed meal

    During the clinical investigation day, plasma propionate will be sampled

  15. Faecal propionate concentrations.

    Time frame: Fecal propionate will be sampled in the morning before the testday

    On the day of clinical investigation day, fecal propionate will be sampled

Secondary outcomes

  1. Energy expenditure, fat and carbohydrate oxidation

    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

    Energy expenditure, fat and carbohydrate oxidation will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands);

  2. 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

    Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).

  3. 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

    Plasma glucose concentrations

  4. 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

    Plasma insulin concentrations

  5. 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

    Plasma FFA concentrations

  6. Faecal microbiota composition

    Time frame: Faecal microbiota composition will be sampled in the morning before the testday

    Faecal microbiota composition will be assessed via16S rRNA gene sequencing

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effects of Human-like Milk Oligosaccharide and Resistant Starch on Acetate Production and Human Substrate Metabolism

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 12, 2021
Registry last updated
Nov 3, 2021

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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