Effect of Arabinoxylan and Rye Kernels on Second Meal Responses

NCT01583270 | Completed

• 2 other identifiers: CERN-biofuncarb second meal2101-08-0068
• 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. Barley, oat and rye may in addition to reducing the acute post prandial glucose response also reduce glucose response at a subsequent meal. Purified dietary fibre has been shown to reduce GI and affect levels of satiety hormones. In contrast, our knowledge of the physiological effect of arabinoxylan, which constitute a substantial part of dietary fibre in cereal products, is limited in relation to second meal effects. The investigators also lack knowledge of the second meal effect of arabinoxyan in combination with rye kernels. Hypothesis: Porridge rich in arabinoxylan and/or whole rye kernels can increase the formation of short chain fatty acids and improve the glycemic response. The aim of the present study is to compare the effect of porridge test meals based on purified arabinoxylan, rye kernels, a combination of arabinoxylan and rye kernels, and semolina porridge as control on acute postprandial response as well as response at a subsequent standardized meal. The study will be conducted in subjects with the metabolic syndrome. The primary endpoint is glucose response. Secondary endpoints are the following items: insulin, incretins, inflammatory markers, ghrelin, free fatty acids, metabolomics, breath hydrogen and subjective satiety feeling. 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

Arabinxylan; Rye kernels; whole grain; Dietary fibre; Metabolic syndrome; Glycemic response; Colon fermentation; Second meal effekt; Satiety

Outcome Measures

Primary Outcomes (1)

• Glucose response after second meal

  2 hours

Secondary Outcomes (6)

• Plasma response after second meal

  2 hours

• Plasma response after test meal

  2 hours

• Breath hydrogen after second meal

  2 hours

• Breath hydrogen after testmeal

  2 hours

• Satiety feeling after second meal

  2 hours

Study Arms (4)

Arabinoxylan

EXPERIMENTAL

Porridge rich in arabinoxylan. 50 g available carbohydrate

Dietary Supplement: Arabinoxylan

rye kernels

EXPERIMENTAL

Porridge made from rye kernels. 50 g available carbohydrate

Dietary Supplement: Rye kernel

arabinoxylan and rye kernels

EXPERIMENTAL

Porridge made of rye kernels and arabinoxylan. 50g available carbohydrate

Dietary Supplement: Arabinoxylan and rye kernels

semolina

EXPERIMENTAL

Semoline porridge. 50 g available carbohydrate

Dietary Supplement: Semolina

Interventions

Arabinoxylan DIETARY_SUPPLEMENT

Porridge rich in arabinoxylan

Also known as: Dietary fibre.

Arabinoxylan

Rye kernel DIETARY_SUPPLEMENT

Porridge made of rye kernels

Also known as: Whole grain. Rye. Kernels.

rye kernels

Arabinoxylan and rye kernels DIETARY_SUPPLEMENT

Porridgde made of rye kernels and arabinoxylan

Also known as: dietary fibre. whole grain. rye kernels.

arabinoxylan and rye kernels

Semolina DIETARY_SUPPLEMENT

Semoline porridge. control meal.

Also known as: Wheat.

semolina

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) and
• 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 and
• pregnancy or lactation.

Sponsors & Collaborators

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

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

arabinoxylan; Dietary Fiber; Flour

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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: April 18, 2012
• First Posted: April 24, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

DK (1)