NCT05260762

Brief Summary

The overall aim of this 12-week randomized controlled trial is to investigate if a dietary fiber supplement rich in arabinoxylans (AX) affects weight loss success differently according to baseline gut microbiota composition in subjects who have overweight or obesity. 105 participants will be randomized in a 2:1 ratio to receive 15 g/day of AX or placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

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

January 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 13, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

January 10, 2022

Last Update Submit

June 21, 2023

Conditions

Overweight and ObesityWeight Loss

Keywords

Gut microbiotaDietary fiber

Outcome Measures

Primary Outcomes (1)

  • Body weight change

    Weight will be measured using a calibrated digital scale,in kg to the nearest 0.1 kg

    Baseline to week 12

Secondary Outcomes (4)

  • Body fat change

    Baseline to week 12

  • Fecal microbiota composition

    Baseline to week 12

  • Blood glucose metabolism

    Baseline to week 12

  • Resting energy expenditure

    Baseline to week 12

Other Outcomes (12)

  • Blood Pressure

    Baseline to week 12

  • Blood cholesterol concentration

    Baseline to week 12

  • Appetite regulating hormones

    Baseline to week 12

  • +9 more other outcomes

Study Arms (2)

Arabinoxylan

ACTIVE COMPARATOR

Arabinoxylan (15 g AX/d) wheat buns

Dietary Supplement: Arabinoxylan

Control

PLACEBO COMPARATOR

Non-fiber, carbohydrate control (15 g /d) wheat buns

Dietary Supplement: Control

Interventions

ArabinoxylanDIETARY_SUPPLEMENT

Dietary fiber product

Arabinoxylan
ControlDIETARY_SUPPLEMENT

Potato starch

Control

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apparently healthy men or women (self-reported nonpregnant, nonlactating, and not planning a pregnancy in the next 4 months)
  • BMI: 25 to 40 kg/m2
  • Non-smoker
  • Want to maintain or lose weight
  • Willing to consume wheat buns on a daily basis

You may not qualify if:

  • Consumption of whole grain products with every meal
  • Use of antibiotics 60 days prior to the start of the study. If a participant uses antibiotics prior to randomization, they will be invited to be re-screened 3 months after the last use of antibiotics, provided that it is realistic to complete the study no later than the scheduled LPLV
  • Dietary supplements with pro- and/or prebiotics 6 weeks prior to study
  • Self-reported eating disorders
  • Being a bodybuilder (\>4 strength training sessions per week)
  • Alcohol intake above the recommendation from the Danish Health and Medicines Authority (\>21 units of alcohol per week)
  • Night- or shift work
  • Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer), asthma, thyroid disease, cardiovascular disease, type 1 or 2 diabetes, inflammatory diseases, and celiac disease
  • Disorders: neurological, sleep, diagnosed psychiatric disorder and gastrointestinal and liver disorders
  • Surgical treatment of obesity and abdominal surgery
  • Inability, physically or mental, to comply with the procedures required by the study protocol as evaluated by the daily study manager, principal investigator or clinical responsible
  • Subject's general condition contraindicates continuing the study as evaluated by the daily study manager, principal investigator or clinical responsible
  • Simultaneous blood donation for another purpose than this study
  • Simultaneous participation in other clinical intervention studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Interventions

arabinoxylan

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 10, 2022

First Posted

March 2, 2022

Study Start

April 13, 2022

Primary Completion

June 13, 2023

Study Completion

June 13, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

DK(1)