NCT03714646

Brief Summary

Based on our hypothesis that orally administered resistant starch and 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

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed
Last Updated

January 13, 2020

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

July 6, 2018

Last Update Submit

January 10, 2020

Conditions

Pre DiabetesObesity

Outcome Measures

Primary Outcomes (2)

  • Plasma acetate concentrations (microM)

    at baseline (before a high-fat mixed meal)

  • Plasma acetate concentrations (microM)

    four hours after a high fat mixed meal

Secondary Outcomes (8)

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

    at baseline and four hours after a high fat mixed meal

  • fat oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)

    at baseline and four hours after a high fat mixed meal

  • carbohydrate oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)

    at baseline and four hours after a high fat mixed meal

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

    at baseline and four hours after a high fat mixed meal

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

    at baseline and four hours after a high fat mixed meal

  • +3 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

beta glucan

ACTIVE COMPARATOR
Dietary Supplement: beta gluten

beta glucan and Resistant Starch

EXPERIMENTAL
Dietary Supplement: beta glucan and resistant starch

Interventions

beta glucan and resistant starchDIETARY_SUPPLEMENT

12g per day the day before the CID Resistant starch 7.5 g

beta glucan and Resistant Starch
PlaceboDIETARY_SUPPLEMENT

isocaloric maltodextrin before the CID

Placebo
beta glutenDIETARY_SUPPLEMENT

12 g beta gluten there day before the CID

beta glucan

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

Maastricht, Limburg, 5229 ER, 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

Glucose IntoleranceObesity

Interventions

beta-GlucansResistant Starch

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydratesStarchBiopolymersPolymersMacromolecular SubstancesDietary FiberDietary CarbohydratesFoodDiet, 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 22, 2018

Study Start

September 5, 2018

Primary Completion

May 10, 2019

Study Completion

May 10, 2019

Last Updated

January 13, 2020

Record last verified: 2018-10

Locations

NL(1)