Effects of Beta-glucan From Barley and Oats on Glucose and Lipid Metabolism, and Satiety

NCT03648112 | Completed

• 1 other identifier: H7_18
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The interventional study will evaluate the effects of a regularly consumption of barley and oat flakes in crude and roasted form on the glucose and lipid metabolism as well as the postprandial saturation. Moreover, the study will evaluate the effect of a regularly consumption of barley and oat flakes on the glucose and lipid metabolism over a period of three weeks. All participants will run through each intervention (cross-over design). Inbetween these intervention periods there will be wash-out phases. In total there will be four interventions: crude oat flakes, roasted oat flakes, crude barley flakes and roasted barley flakes. The comparison will be made against white toastbread. The study participants will visit the study centrum before and after each intervention over an entire period of 27 weeks.

Conditions

Lipid Metabolism; Glucose Metabolism; Satiety

Keywords

dietary fibres; ß-glucan; low-density-lipoprotein-cholesterol; insulin; fasting glucose; microbiota

Outcome Measures

Primary Outcomes (1)

• LDL cholesterol

  LDL cholesterol \[mmol/L\]

  [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]

Secondary Outcomes (14)

• total cholesterol

  [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]

• HDL cholesterol

  [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]

• triacylglycerides

  [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]

• HOMA-index

  [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

• fasting blood glucose

  [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

Study Arms (5)

Intervention 1

ACTIVE COMPARATOR

Intervention 1: Crude oat flakes (dietary supplement) 80 g of crude oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients. The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes.

Dietary Supplement: Intervention 1

Intervention 2

ACTIVE COMPARATOR

Roasted oat flakes (dietary supplement) 80 g of roasted oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß-glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients. These oat flakes were roasted at 150°C for 20 minutes. The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes.

Dietary Supplement: Intervention 2

Intervention 3

ACTIVE COMPARATOR

Crude barley flakes (dietary supplement) 80 g of crude oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß-glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients. The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes

Dietary Supplement: Intervention 3

Intervention 4

ACTIVE COMPARATOR

Roasted barley flakes (dietary supplement) 80 g of roasted oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß-glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients. The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes.

Dietary Supplement: Intervention 4

control

PLACEBO COMPARATOR

White toastbread (control) (dietary supplement) White toastbread was chosen because of its low fibre content. To achieve the same energy value (kcal) as 80 g cereal flakes the participants have to consume four slices of white toastbread. The study participants receive recipes for breakfast for 21 days. The recipes imply four slices of white toastbread.

Dietary Supplement: Control

Interventions

Intervention 1 DIETARY_SUPPLEMENT

The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes per day.

Also known as: Crude oat flakes

Intervention 1

Intervention 2 DIETARY_SUPPLEMENT

The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes per day.

Also known as: Roasted oat flakes

Intervention 2

Intervention 3 DIETARY_SUPPLEMENT

The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes per day.

Also known as: Crude barley flakes

Intervention 3

Intervention 4 DIETARY_SUPPLEMENT

The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes per day.

Also known as: Roasted barley flakes

Intervention 4

Control DIETARY_SUPPLEMENT

White toastbread (control) (dietary supplement) White toastbread was chosen because of its low fibre content. To achieve the same energy value (kcal) as 80 g cereal flakes the participants have to consume four slices of white toastbread. The study participants receive recipes for breakfast for 21 days. The recipes imply four slices of white toastbread.

Also known as: White toast bread

control

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LDL-cholesterol ≥ 120 mg/dl (≥ 3 mmol/l)
• Typical western diet

You may not qualify if:

• intake of lipid-lowering medications
• gastrointestinal diseases
• diabetes mellitus type I and II
• familial hypercholesterolemia
• intake of additional dietary supplements (especially ß-glucan capsules, high-fibre compounds)
• pregnancy, lactation
• appreciable food allergies/intolerances
• patient´s request or if patient compliance with the study protocol is doubtful

Sponsors & Collaborators

• University of Jena: lead

Study Sites (1)

Friedrich-Schiller-University

Jena, Thuringia, 07743, Germany

Location

Related Publications (1)

• Reiners S, Hebestreit S, Wedekind L, Kiehntopf M, Klink A, Rummler S, Glei M, Lorkowski S, Schlormann W, Dawczynski C. Effect of a regular consumption of traditional and roasted oat and barley flakes on blood lipids and glucose metabolism-A randomized crossover trial. Front Nutr. 2023 Feb 2;10:1095245. doi: 10.3389/fnut.2023.1095245. eCollection 2023.

  PMID: 36819683 DERIVED

Related Links

• Study results

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

• Christine Dawczynski, PhD

  University of Jena

  PRINCIPAL INVESTIGATOR

• Stefan Lorkowski, PhD

  University of Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leader of the Junior Research Group Nutritional Concepts

Model Details: crossover design

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 27, 2018
• Study Start: May 2, 2018
• Primary Completion: May 31, 2018
• Study Completion: July 31, 2019
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

DE (1)