Metabolic Activation With Protein-rich Formula Diet

• Register: ClinicalTrials.gov
• Last refreshed on: 5 February 2024
• Main ID: NCT02230501
• Date of registration: 26/08/2014
• Prospective Registration: No
• Primary sponsor: West German Center of Diabetes and Health
• Public title: Metabolic Activation With Protein-rich Formula Diet AVS
• Scientific title: Metabolic Activation With Protein-rich Formula Diet - a Randomized-controlled Trial
• Date of first enrolment: February 2011
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02230501
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Triple (Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type 2 diabetes mellitus

- HbA1c > 7,5%

- Body Mass Index (BMI) = 27,5 kg/m2

Exclusion Criteria:

- acute infections

- severe diseased with hospital stay during the last 3 months

- chronic diseases

- chemotherapy or cortisone treatment

- weight loss of more than 2 kg per week during the last month

- smoking cessation during the last 3 months or planned

- weight-influencing medication

- pregnancy, breast-feeding or lack of contraception

- high-level physical activity of more than 1h per day

- incompatibility with components of the PRMR

- participation in an other study during the last 6 months

For the open-label registry, the only inclusion criterium is type 2 diabetes.



Age minimum: 25 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Dietary Supplement: stringent diet regimen

Dietary Supplement: moderate diet regimen

Primary Outcome(s)

HbA1c [Time Frame: 12 weeks]

Secondary Outcome(s)

blood pressure [Time Frame: 12 weeks and 1 year]

cholesterol [Time Frame: 12 weeks and 1 year]

nutrition [Time Frame: 12 weeks and 1 year]

body weight [Time Frame: 12 weeks and 1 year]

antidiabetic medication [Time Frame: 12 weeks and 1 year]

physical activity [Time Frame: 12 weeks and 1 year]

quality of life [Time Frame: 12 weeks and 1 year]

fasting blood glucose [Time Frame: 12 weeks and 1 year]

HbA1c [Time Frame: 1 year]

Secondary ID(s)

AVS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Almased Wellness GmbH