Effect of Dietary Fibre and Whole Grain on the Metabolic Syndrome

NCT01316354 | Completed DMC

• 1 other identifier: CERN-BioFunCarb
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Sedentary lifestyles and increasing obesity are main causes of the global increase in the prevalence of the metabolic syndrome (Mets) and type 2 diabetic (T2DM). Diet quality, particularly composition of carbohydrate play also a significant role. The glycemic index (GI) describes in relative terms rise of blood glucose after ingestion of carbohydrate-rich food. Purified dietary fibre as β-glucan (BG) has been shown to reduce GI and affect levels of satiety hormones. In contrast, our knowledge of the physiological effects of arabinoxylans (AX), which constitute a substantial part of dietary fibre in cereal products, is limited. The investigators also lack a deeper understanding of the importance of whole grain (whole grain with whole kernels, and purified dietary fibre) in relation to Mets and T2DM. Hypothesis: The composition of dietary carbohydrates can be designed so that they improve the glycemic and insulinaemic responses and increase satiety feeling. This can be detected in metabolic parameters in subjects with Mets. The aim of our study is in subjects with Mets to compare the effect of acute consumption of bread rich in (a) purified AX, (b) purified BG, (c) rye bread with whole kernels (RK), with a (d) control group with consumption of white bread (WB). The primary endpoint is GI. Secondary endpoints are the following items: glycemic load, insulin index, glucose, insulin, glucagon, inflammatory markers, incretins, rate of gastric emptying, and metabolomics. Also satiety feeling will be measured. This project will improve opportunities for identifying and designing foods with low GI that is particularly suited to people who are at high risk of developing T2DM. The investigators also expect to gain a greater understanding of the metabolic fingerprint, as seen after ingestion of low-GI foods and thereby gain a molecular understanding of how low-GI foods affect health by altering metabolic processes. This will give us a deeper insight into the metabolic processes that are necessary for maintaining normal glucose homeostasis.

Conditions

Metabolic Syndrome

Keywords

Arabinoxylan; Beta glucan; Whole grain; Dietary fibre; Metabolic syndrome; Glycemic index; Satiety

Outcome Measures

Primary Outcomes (1)

• Glycaemic index of breads with arabinoxylan and beta-glucan compared with whole grain breads in subject with the metabolic syndrome

  4,5 hours

Secondary Outcomes (1)

• Glycemic response and satiety

  4,5 hours

Study Arms (4)

Beta-glucan

EXPERIMENTAL

Bread with purified beta-glucan

Other: Bread types

Rye kernels

EXPERIMENTAL

Rye bread with kernels

Other: Bread types

White bread

EXPERIMENTAL

White bread

Other: Bread types

Arabinoxylan

EXPERIMENTAL

Bread with Purified arabinoxylan

Other: Bread types

Interventions

Bread types OTHER

Bread with 50 g available carbohydrate

Arabinoxylan; Beta-glucan; Rye kernels; White bread

Eligibility Criteria

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

You may qualify if:

• central obesity (Female \> 94 cm; Male \> 80 cm) with two of the following: -- fasting triglyceride (\> 1,7 mmol/L)
• HDL-cholesterol: (Female: \< 1,03 mmol/L; Male: \< 1,29 mmol/L)
• blood pressure (≥ 130/85 mmHg)
• fasting plasma glucose (≥ 5,6 mmol/L)) Subjects who are in medical treatment with lipid and blood pressure-lowering drugs can continue with their habitual treatment provided that the treatment is stable throughout the trial.

You may not qualify if:

• fasting plasma glucose \> 7,0 mmol/l
• fasting plasma triglyceride \> 5,0 mmol/l
• blood pressure \> 160/100 mmHg
• legal incapacity
• endocrine, cardiovascular or kidney disease
• BMI \> 38kg/m2
• corticosteroid treatment
• alcohol or drug addiction
• pregnancy or lactation.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

Location

Related Publications (2)

• Krishnan S, Hendriks HF, Hartvigsen ML, de Graaf AA. Feed-forward neural network model for hunger and satiety related VAS score prediction. Theor Biol Med Model. 2016 Jul 7;13(1):17. doi: 10.1186/s12976-016-0043-4.

  PMID: 27387922 DERIVED

• Nielsen KL, Hartvigsen ML, Hedemann MS, Laerke HN, Hermansen K, Bach Knudsen KE. Similar metabolic responses in pigs and humans to breads with different contents and compositions of dietary fibers: a metabolomics study. Am J Clin Nutr. 2014 Apr;99(4):941-9. doi: 10.3945/ajcn.113.074724. Epub 2014 Jan 29.

  PMID: 24477039 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kjeld Hermansen, Professor

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Kjeld Hermansen

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

DK (1)