Effects of Berries and Berry Fractions on Metabolic Diseases

University of Turku

Status: Completed

Conditions: Type 2 Diabetes; Atherosclerosis

Treatments: Dietary Supplement: Bilberries; Dietary Supplement: Sea buckthorn oil; Dietary Supplement: Sea buckthorn berry; Dietary Supplement: Sea buckthorn phenolic extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01860547

TYBID1

Details and patient eligibility

About

The study hypothesis is that the bioactive compounds of sea buckthorn berries (Hippophaë rhamnoides), their fractions, and bilberries (Vaccinium myrtillus). have positive effects on lipid and carbohydrate metabolism and will thus reduce the risk of developing metabolic diseases.

Full description

The aim of the project was to investigate whether it is possible to reduce the risk of metabolic diseases with supplementing the diet with sea buckthorn berries (Hippophaë rhamnoides), their bioactive fractions, and bilberries (Vaccinium myrtillus). The study design was a randomized cross-over clinical trial. The participants were slightly and moderately overweight female subjects. In total, 110 female volunteers were recruited, and they followed four different berry diets (bilberry, sea buckthorn, sea buckthorn phenolic extract and sea buckthorn oil) in a randomized order for 33-35 days. Each intervention was followed by a wash-out period of 30-39 days. Blood samples were drawn and physical measurements were performed after each period. Eighty volunteers completed the study. Different markers of lipid and carbohydrate metabolism and inflammation were measured form the blood samples.

Enrollment: 110 patients

Sex: Female

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 26-34
• total cholesterol 4.5-8 mmol/l
• LDL chol >2.5 mmol/l
• triglycerides <4 mmol/l
• glucose <6 mmol/l
• insulin <25 mU/l
• blood pressure <160/99 mm Hg
• hemoglobin >120 g/l
• thyroid-stimulating hormone 0.3-4.2 mU/l
• ALAT <60 U/l
• creatinine <115 umol/l

Exclusion criteria

• pregnancy
• menopause,
• regular smoking
• previously diagnosed diabetes (other than gestational)
• thyroid, renal, hematological, or hepatic dysfunction
• previous myocardial infarction
• cardiovascular medication
• treatment with regular medication other than allergy medication or joint lubricates
• on-going inflammatory disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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110 participants in 4 patient groups

bilberry

Experimental group

Treatment:

Dietary Supplement: Bilberries

sea buckthorn berry

Experimental group

Treatment:

Dietary Supplement: Sea buckthorn berry

sea buckthorn phenolic extract

Experimental group

Treatment:

Dietary Supplement: Sea buckthorn phenolic extract

sea buckthorn oil

Experimental group

Treatment:

Dietary Supplement: Sea buckthorn oil