NCT03711383

Brief Summary

Based on our hypothesis that orally administered resistant starch and inulin/beta glucan will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective: To investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

January 14, 2020

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

July 6, 2018

Last Update Submit

January 10, 2020

Conditions

ObesityPre Diabetes

Outcome Measures

Primary Outcomes (1)

  • Plasma acetate concentrations (microM)

    At baseline and up to four hours after a high-fat mixed meal of each CID

Secondary Outcomes (6)

  • Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)

    At baseline and up to four hours after a high-fat mixed meal of each CID

  • Fat oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)

    At baseline and up to four hours after a high-fat mixed meal of each CID

  • Carbohydrate oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)

    At baseline and up to four hours after a high-fat mixed meal of each CID

  • Circulating hormone concentrations (Insulin, GLP-1, PYY)

    At baseline and up to four hours after a high-fat mixed meal of each CID

  • Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)

    At baseline and up to four hours after a high-fat mixed meal of each CID

  • +1 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

isocaloric maltodextrin the day before CIDs

Dietary Supplement: Placebo

Inulin

ACTIVE COMPARATOR

12 g of inulin + isocaloric maltodextrin the day before CID

Dietary Supplement: Inulin

Inulin and Resistant Starch

EXPERIMENTAL

12 g inulin + 7.5 g resistant starch the day before CID

Dietary Supplement: Inulin and Resistant Starch

Interventions

Inulin and Resistant StarchDIETARY_SUPPLEMENT

12g per inulin in combination 7.5 g resistant starch per day the day before the CID Resistant starch 7.5 g

Inulin and Resistant Starch
InulinDIETARY_SUPPLEMENT

12g per inulin in combination with maltodextrin per day the day before the CID

Inulin
PlaceboDIETARY_SUPPLEMENT

isocaloric maltodextrin before test day

Placebo

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2)
  • normoglycemic
  • aged 30 - 65 years
  • overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2)
  • pre-diabetes
  • aged between 30 - 65 years.

You may not qualify if:

  • diabetes mellitus
  • gastroenterological diseases or major abdominal surgery (allowed i.e.: - appendectomy, cholecystectomy)
  • lactose intolerance and other digestive disorders
  • cardiovascular disease, cancer, liver or kidney malfunction (determined -based on ALAT and creatinine levels, respectively)
  • disease with a life expectancy shorter than 5 years
  • Use of probiotics or prebiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (1)

  • Canfora EE, Hermes GDA, Muller M, Bastings J, Vaughan EE, van Den Berg MA, Holst JJ, Venema K, Zoetendal EG, Blaak EE. Fiber mixture-specific effect on distal colonic fermentation and metabolic health in lean but not in prediabetic men. Gut Microbes. 2022 Jan-Dec;14(1):2009297. doi: 10.1080/19490976.2021.2009297.

    PMID: 34923911DERIVED

MeSH Terms

Conditions

ObesityGlucose Intolerance

Interventions

InulinResistant Starch

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharidesDietary FiberFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2018

First Posted

October 18, 2018

Study Start

February 20, 2018

Primary Completion

November 15, 2018

Study Completion

November 15, 2018

Last Updated

January 14, 2020

Record last verified: 2018-10

Locations

NL(1)