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

NCT05354245 | Completed

• 1 other identifier: NL80459.068.22
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insulin Resistance; Impaired Glucose Tolerance; PreDiabetes; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Peripheral insulin sensitivity

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

  12 weeks

Secondary Outcomes (10)

• Insulin sensitivity (hepatic and adipose tissue)

  12 weeks

• Gut permeability

  12 weeks

• Inflammation

  12 weeks

• Energy and substrate metabolism

  12 weeks

• Neurocognitive functioning

  12 weeks

Study Arms (2)

Fibre mixture group

EXPERIMENTAL

Use of a fibre mixture (3 times daily, 5 grams per gift, total of 15 grams per day) during 12 weeks

Dietary Supplement: Fibre supplement (potato-pectin); Dietary Supplement: High-protein diet

Placebo group

PLACEBO COMPARATOR

Use of a placebo (maltodextrin, isocaloric manner, 3 times daily) during 12 weeks.

Dietary Supplement: Placebo; Dietary Supplement: High-protein diet

Interventions

Fibre supplement (potato-pectin) DIETARY_SUPPLEMENT

Fibre supplement

Fibre mixture group

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Also known as: Maltodextrin

Placebo group

High-protein diet DIETARY_SUPPLEMENT

High-protein diet

Fibre mixture group; Placebo group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Carbohydrate Competence Center: collaborator

Study Sites (1)

Maastricht University

Maastricht, 6229ER, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 32122428 BACKGROUND

• 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.

  PMID: 32865024 BACKGROUND

• 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.

  PMID: 26260141 BACKGROUND

• 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.

  PMID: 30670819 BACKGROUND

• 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.

  PMID: 28539646 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance; Glucose Intolerance; Prediabetic State; Overweight; Obesity

Interventions

maltodextrin; Diet, High-Protein

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Diabetes Mellitus; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ellen E Blaak, Prof.Dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: April 29, 2022
• Study Start: September 8, 2022
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

NL (1)