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CompletedNCT02347293Updated May 27, 2015

Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety

An Early Phase 1 interventional study of High levels of indigestible carbohydrates and Low levels of indigestible carbohydrates in Obesity and Metabolic Syndrome, sponsored by Lund University. Completed at 1 site in Sweden. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-27.

Sponsored by Lund University · Early Phase 1, Interventional, and Prevention

Phase
Early Phase 1
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
All
01

Study summary

The experimental model is a semi-acute, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation and satiety in healthy subjects.

02

Conditions studied

  • Obesity
  • Metabolic Syndrome

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03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 329 are open to participants now.

This study's enrollment of 21 is below the median of 60 across 1,459 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Lund University is the lead sponsor of 230 studies on the registry; 37 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Normal fasting blood glucose
  • BMI 19-25 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Gastrointestinal diseases
  • Food allergies e.g. lactose-, gluten intolerance
  • Metabolic disorder e.g. diabetes
  • Tobacco/snuff users
  • No antibiotic or probiotic intake 2 weeks prior and during study.
  • Vegetarians
05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    + ind. CHO

    Test meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables

    Other: High levels of indigestible carbohydrates

  • Experimental
    - ind. CHO

    Reference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables

    Other: Low levels of indigestible carbohydrates

Interventions

  • OtherHigh levels of indigestible carbohydrates
  • OtherLow levels of indigestible carbohydrates
06

What researchers measure

Primary outcomes

  1. Blood Glucose, levels of glucose in blood

    Time frame: Postprandial 0-180 min after breakfast

  2. Insulin, levels of insulin in blood

    Time frame: Postprandial 0-180 min after breakfast

  3. Appetite hormones, levels of Peptide YY (PYY) in blood

    Time frame: Postprandial 0-180 min after breakfast

  4. Markers of colonic fermentation, levels of hydrogen in breath

    Time frame: Postprandial 0-180 min after breakfast

  5. Inflammation markers, levels of Interleukin-6 (IL-6) in blood

    Time frame: Postprandial 0-180 min after breakfast

Secondary outcomes

  1. Subjective satiety, as measured by VAS

    Time frame: Postprandial 0-180 min after breakfast

07

Study locations

1 site
  • Medicon Village
    Lund, Sweden
08

References and documents

Publications

  • Gyll J, Ridell K, Ohlund I, Karlsland Akeson P, Johansson I, Lif Holgerson P. Vitamin D status and dental caries in healthy Swedish children. Nutr J. 2018 Jan 16;17(1):11. doi: 10.1186/s12937-018-0318-1. PubMed 29338758 ↗
  • Sandberg JC, Bjorck IME, Nilsson AC. Effects of whole grain rye, with and without resistant starch type 2 supplementation, on glucose tolerance, gut hormones, inflammation and appetite regulation in an 11-14.5 hour perspective; a randomized controlled study in healthy subjects. Nutr J. 2017 Apr 21;16(1):25. doi: 10.1186/s12937-017-0246-5. PubMed 28431559 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02347293
Lead sponsor
Lund University
Responsible party
Jonna Sandberg (MSc, postgraduate student, Lund University) — Principal investigator
First posted
Jan 27, 2015
Start date
Oct 2014
Primary completion
May 2015
Completion
May 2015
Last update
May 27, 2015

Study contacts

Anne Nilsson, PhD
principal investigator · Lund University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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