Impact of Branched-chain Amino Acids in the Development of Insulin Resistance (BRAAWO)

German Diabetes Center

Status: Completed

Conditions: Diabetes

Treatments: Dietary Supplement: Branched-chain amino acids reduced intake

Study type: Interventional

Funder types: Other

Identifiers

NCT03261362

2014092783

Details and patient eligibility

About

The purpose of this study is to clarify the role of the branched-chain amino acids in the development of Insulin resistance in patients with diabetes

Full description

The proposed project aims to elucidate the role of the BCAA in the development of insulin resistance and type 2 diabetes. The project tests the hypothesis that a diet induced decrease of BCAAs concentrations alter the metabolic mechanisms involved in the control insulin resistance and diabetes progression.

The specific aims are to elucidate the effect of the diet induced decrease of BCAAs concentrations on (I) peripheral and hepatic insulin sensitivity (II) ectopic fat distribution (III) energy metabolism (IV) metabolic and inflammatory status

Enrollment: 12 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes type 2
• Non smokers
• Untrained
• Willingness to adhere to a diet intervention

Exclusion criteria

• Chronic disease
• Pregnancy
• Cancer
• Antibiotic therapy
• Drug/alcohol abuse
• Competitive athletes

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Amino acid powder with all amino acids

Placebo Comparator group

Description:

amino acid powder 80 g oral Administration 1 week

Treatment:

Dietary Supplement: Branched-chain amino acids reduced intake

Amino acid powder without BCAAs-reduced intake

Active Comparator group

Description:

Branched-chain amino acids reduced intake - amino acid powder lacking BCAAs 80 g oral Administration 1 week -

Treatment:

Dietary Supplement: Branched-chain amino acids reduced intake