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

University of Jena

Status: Completed

Conditions: Satiety; Lipid Metabolism; Glucose Metabolism

Treatments: Dietary Supplement: Intervention 2; Dietary Supplement: Intervention 4; Dietary Supplement: Intervention 1; Dietary Supplement: Intervention 3; Dietary Supplement: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03648112

H7_18

Details and patient eligibility

About

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.

Full description

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.

By applying the cross-over design, all participants will run through each intervention. In total there will be four interventions: crude oat flakes, roasted oat flakes, crude barley flakes and roasted barley flakes. Each intervention period will last three weeks and will be separated by wash-out phases which also will last three weeks. The comparison will be made against white toastbread, which will be the fifth intervention. The entire duration of the study will be 27 weeks (5x 3 weeks intervention + 4x 3 weeks wash-out phases inbetween).

The participants will visit the study centrum before and after each intervention for examinations and for taking blood samples. During the examination the participants will receive a test-meal to evaluate postprandial blood glucose and insulin levels. Moreover, the kinetic of hormones that influence the satiety will be evaluated. In addition to the examination of blood samples, the microbiota of feces will be examined.

During the intervention periods the participants will receive recipes for breakfast for 21 days. In these recipes 80 gram oat or barley flakes or four slices of white toastbread will be included.

The study will provide data about the association between different processed cereals and measurable markers reflecting glucose and lipid metabolism as well as their influence on hormones of satiety and microbiota.

Enrollment: 32 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 5 patient groups, including a placebo group

Intervention 1

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Intervention 1

Intervention 2

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Intervention 2

Intervention 3

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Intervention 3

Intervention 4

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Intervention 4

control

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Control