ClinicalTrials.gg
RecruitingNCT05590611SOBERUpdated Jun 5, 2023

Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility

An interventional study of Dietary Intervention with Brown Bread and Dietary Intervention with Sourdough Bread in Appetite Regulation, Energy Intake and Body Weight Changes, sponsored by KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by KU Leuven · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The present study is a pilot study examining whether long-term sourdough bread consumption reduces energy intake and blood lipids levels over a period of 4 weeks in free-living normalweight and overweight participants.

02

Conditions studied

  • Appetite Regulation
  • Energy Intake
  • Body Weight Changes
  • Eating Behavior
  • Overweight and Obesity
03

In context

Body Weight Changes

231 studies on the registry are indexed under Body Weight Changes; 30 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 179 interventional studies indexed under Body Weight Changes.

Browse Body Weight Changes studies →

Lead sponsor

KU Leuven is the lead sponsor of 373 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female and male participants
  • Age range 18 - 50
  • range >20 kg/m2 at screening visit
  • Regular eating pattern (3 meals per day on at least 5 days per week)
  • Habitual brown bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
  • Stable body weight for the last 6 months

Exclusion criteria

Exclusion Criteria:

  • Currently smoking or willingness to smoke during the study period
  • Pregnancy, lactation or wish to become pregnant during the study period
  • Previous or current gastrointestinal or endocrine disorders
  • Previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)
  • Coeliac disease or gluten sensitivity
  • Allergy/intolerance to milk, egg, nuts, soy or sesame
  • Habitual sourdough bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
  • Excessive concern about eating habits or body weight as evidenced from scores \< 18 on the restraint and disinhibition subscales of the Three-Factor Eating Questionnaire (Stunkard \& Messick, 1985)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Placebo comparator
    Brown Bread

    Other: Dietary Intervention with Brown Bread

  • Active comparator
    Wholemeal Sourdough Bread

    Other: Dietary Intervention with Sourdough Bread

Interventions

  • OtherDietary Intervention with Brown Bread

    The participants in this group will be asked to replace all their habitual bread intake by standard brown bread. The duration of the study for each participant is 4 weeks. Apart from the change in type of bread, participants will maintain their habitual diet.

  • OtherDietary Intervention with Sourdough Bread

    The participants in thisgroup will be asked to replace all their habitual bread intake by wholemeal sourdough bread. The duration of the study for each participant is 4 weeks. Apart from the change in type of bread, participants will maintain their habitual diet.

06

What researchers measure

Primary outcomes

  1. Energy intake (kilocalories)

    Assessed via 4-day food diaries using a mobile app

    Time frame: 4 weeks

Secondary outcomes

  1. Body weight

    Time frame: 4 weeks

  2. Blood lipid levels

    Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — No IPD will be shared with other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05590611
Lead sponsor
KU Leuven
Responsible party
Kristin Verbeke (Full professor, KU Leuven) — Principal investigator
First posted
Oct 21, 2022
Start date
Dec 1, 2022
Primary completion
Sep 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jun 5, 2023

Study contacts

Georgia Chatonidi
Contact
georgia.chatonidi@kuleuven.be
+3216194324
Kristin Verbeke
principal investigator · KU Leuven

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion