AzTrials
AzTrials

Insulin ResistanceDISTALNCT05354245

Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)

A study testing Fibre supplement (potato-pectin) and High-protein diet in people with Insulin Resistance and Impaired Glucose Tolerance, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to investigate the effects of a fibre mixture added to a high-protein diet on metabolic, gut and brain health. Read more about this study

Who is it for?
Ages 30 to 75 yearsHealthy volunteers can take part
What is being tested?
Fibre supplement (potato-pectin) and High-protein diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteNetherlands
Study dates
8 Sep 2022to 10 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 30-75 years
  • Male/female
  • BMI 28-40 kg/m2
  • Impaired fasting glucose or glucose tolerance, determined using the following criteria (participant should meet at least one criteria):
  • HbA1c 42-47 mmol/mol OR fasting glucose (>10h fasted) 5.6-6.9 mmol/l OR Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) >1.85

Who cannot join

  • Diabetes mellitus (type 1 or 2)
  • Cardiovascular disease (except hypertension (<160/100mmHg is allowed), pulmonary disease, kidney disease/failure, liver disease/failure
  • Gastrointestinal disease or a history of abdominal surgery (except appendectomy and cholecystectomy)
  • Diseases affecting glucose and/or lipid metabolism
  • Malignancy (except non-invasive skin cancer)
  • Auto-immune disease
Show all 23Show fewer
  • Major mental disorders
  • Ongoing (infectious) disease or any disease with a life expectancy ≤5 years
  • Substance abuse (nicotine abuse (including e-cigarettes) defined as >20 cigarettes per day; alcohol abuse defined as ≥8 drinks/week for females and ≥15 drinks/week for males(38); any drugs)
  • A change in weight ≥3kg over the last 3 months or plans to lose weight or follow a hypocaloric diet during the study period
  • Pre/pro/antibiotic use in the last 3 months or during the study
  • Use of medication that influences glucose or fat metabolism and inflammation, such as:
  • Use of statins (stable use ≥3 months prior to and during study is allowed)
  • Use of antidepressants (stable use ≥3 months prior to and during study is allowed)
  • Use of specific anticoagulants
  • Use of medication known to interfere with study outcomes
  • Use of β-blockers
  • Chronic corticosteroid treatment (>7 consecutive days)
  • Regular use of laxatives 3 months prior to the study or during study period
  • Change in physical activity or diet during study period
  • Intensive physical activity (>3h per week)
  • Pregnancy
  • Following a vegan or vegetarian diet; presence of food allergies, intolerances or diet restrictions interfering with the study.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University

    Maastricht, 6229ER

Other trials in Netherlands

About this study

Official title: Using a Complex Carbohydrate Mixture Added to a High-protein Diet to Steer Fermentation and Improve Metabolic, Gut and Brain Health

The purpose of this study is to investigate the effects of a fibre mixture added to a high-protein diet on metabolic, gut and brain health.

Read the detailed description

The fibre mixture that will be investigated is hypothesized to improved metabolic, gut and brain health. It potentially increases insulin sensitivity, satiety, gut barrier function, improves food-reward related brain activity and decreases inflammation, gut permeability, and ectopic lipid accumulation, among other potential health effects.

The fibre mixture will be administrated during 12 weeks combined a high-protein diet. The placebo-controlled parallel design of the study allows for a placebo group to use maltodextrin combined with a high-protein diet for 12 weeks. The high-protein diet is known to increase satiety and might enhance the difference between the intervention and placebo groups in terms of outcome measurements. The potential health effects as described earlier will be investigated using different techniques.

Being tested
Fibre supplement (potato-pectin), Placebo, High-protein diet
Medical subject headings
Insulin Resistance, Glucose Intolerance, Prediabetic State, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fibre supplement (potato-pectin)Dietary supplement

    Fibre supplement

  • PlaceboDietary supplement

    Also called Maltodextrin

    Maltodextrin

  • High-protein dietDietary supplement

    High-protein diet

Study groups in NCT05354245
Study groupRoleWhat they receive
Fibre mixture groupExperimentalUse of a fibre mixture (3 times daily, 5 grams per gift, total of 15 grams per day) during 12 weeks
Receives: Dietary Supplement: Fibre supplement (potato-pectin); Dietary Supplement: High-protein diet
Placebo groupPlacebo comparatorUse of a placebo (maltodextrin, isocaloric manner, 3 times daily) during 12 weeks.
Receives: Dietary Supplement: Placebo; Dietary Supplement: High-protein diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peripheral insulin sensitivity

    Change in peripheral insulin sensitivity between the two groups. Measured using a two-step hyperinsulinemic-euglycemic clamp

    Measured: 12 weeks

Secondary outcomes (10)

  1. Insulin sensitivity (hepatic and adipose tissue)

    Change in insulin sensitivity between the two groups. Measured using a two-step hyperinsulinemic-euglycemic clamp

    Measured: 12 weeks

  2. Gut permeability

    Difference in change between the groups. Measured using multisugar test

    Measured: 12 weeks

  3. Inflammation

    Difference in change between the groups. Measured using serum values.

    Measured: 12 weeks

  4. Energy and substrate metabolism

    Difference in change between the groups. Measured using serum values (circulating metabolites) and indirect calorimetry (energy harvest and expenditure)

    Measured: 12 weeks

  5. Neurocognitive functioning

    Difference in change between the groups. Measured using neurocognitive tests and functional Magnetic Resonance Imaging (fMRI).

    Neurocognitive functioning will be measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB) (a combination of different digital tests) to assess response time in seconds and quality of delivered results. fMRI assesses food-reward related brain activity.

    Measured: 12 weeks

  6. Food reward related brain activity

    Difference in change between the groups. Measured using neurocognitive tests and fMRI.

    Neurocognitive functioning will be measured using CANTAB (a combination of different digital tests) to assess response time in seconds and quality of delivered results. fMRI assesses food-reward related brain activity

    Measured: 12 weeks

  7. Tissue metabolism (subcutaneous visceral adipose tissue, skeletal muscle tissue)

    Difference in change between the groups regarding receptor expression and metabolic changes in different pathways (lipolysis, insulin signalling etc)

    Measured: 12 weeks

  8. Microbiome composition and functionality

    Difference in change between the groups. Measured using 16S-RNA sequencing and faecal analysis of substrates of saccharolytic and proteolytic fermentation.

    Measured: 12 weeks

  9. Gastrointestinal side-effects of dietary supplement

    Difference in change between the groups. Measured by gastrointestinal symptom rating scale and questionnaires on general wellbeing.

    Gastro-intestinal symptom rating scale: 15 questions on 7-point Likert scale (1 = strongly disagree; 7 = strongly agree)

    Measured: 12 weeks

  10. Stool consistency

    Difference in change between the groups. Measured by bristol stool scale (7-point scale (1 = solid feces, 7 = severe diarrhoea)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start8 Sep 2022
  3. Primary completion10 Jun 2024
  4. Study completion10 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05354245
Sponsor's protocol ID
NL80459.068.22
Acronym
DISTAL
Status last verified
Jun 2024
First submitted
22 Feb 2022
Last updated
27 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Blaak EE. Current metabolic perspective on malnutrition in obesity: towards more subgroup-based nutritional approaches? Proc Nutr Soc. 2020 Aug;79(3):331-337. doi: 10.1017/S0029665120000117. Epub 2020 Mar 3.

    PubMed 32122428

  • Blaak EE, Canfora EE, Theis S, Frost G, Groen AK, Mithieux G, Nauta A, Scott K, Stahl B, van Harsselaar J, van Tol R, Vaughan EE, Verbeke K. Short chain fatty acids in human gut and metabolic health. Benef Microbes. 2020 Sep 1;11(5):411-455. doi: 10.3920/BM2020.0057. Epub 2020 Aug 31.

    PubMed 32865024

  • Canfora EE, Jocken JW, Blaak EE. Short-chain fatty acids in control of body weight and insulin sensitivity. Nat Rev Endocrinol. 2015 Oct;11(10):577-91. doi: 10.1038/nrendo.2015.128. Epub 2015 Aug 11.

    PubMed 26260141

  • Canfora EE, Meex RCR, Venema K, Blaak EE. Gut microbial metabolites in obesity, NAFLD and T2DM. Nat Rev Endocrinol. 2019 May;15(5):261-273. doi: 10.1038/s41574-019-0156-z.

    PubMed 30670819

  • Canfora EE, van der Beek CM, Jocken JWE, Goossens GH, Holst JJ, Olde Damink SWM, Lenaerts K, Dejong CHC, Blaak EE. Colonic infusions of short-chain fatty acid mixtures promote energy metabolism in overweight/obese men: a randomized crossover trial. Sci Rep. 2017 May 24;7(1):2360. doi: 10.1038/s41598-017-02546-x.

    PubMed 28539646

Questions about this trial

What is this clinical trial studying?

A study testing Fibre supplement (potato-pectin) and High-protein diet in people with Insulin Resistance and Impaired Glucose Tolerance, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peripheral insulin sensitivity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05354245, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in