Metabolic Activation With Protein-rich Formula Diet (AVS)

Metabolic Activation With Protein-rich Formula Diet - a Randomized-controlled Trial

Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT 01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting >100 IE insulin/day. The aim of the present study was to investigate in a randomized-controlled trial if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or insulin.

A second part of the study is an open-label registry for persons with type 2 diabetes, who will perform the lifestyle intervention with the stringent diet regime.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: moderate diet regimen; Dietary supplement: stringent diet regimen

Detailed Description

Type 2 diabetes mellitus (T2DM) patients had been randomized into two groups. During the 1st week the intervention group with stringent diet regime replaced 3 main meals by 50 g PRMR (Almased-Vitalkost, Almased Wellness GmbH, Bienenbüttel, Germany) each (=1100 kcal/day). In 2nd-4th week 2 meals were replaced and a protein-rich lunch was allowed. In 5th-12th week only dinner was replaced. The control group with moderate diet regime replaced breakfast and dinner for 4 weeks and then only dinner during the next 8 weeks. Clinical parameters were determined at the study center at baseline, after 4, 8 and 12 weeks. Primary endpoint was reduction of HbA1c, secondary endpoints reduction of weight and antidiabetic medication.

In the second part of the study type 2 diabetes patients are included in an open-label reistry and perform the lifestyle intervention with the stringent diet regime.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany, 40591
    • West German Centre of Diabetes and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: moderate diet regimen; Week 1-4: replacement of breakfast and dinner with 1g PRMR /kg normal weight (=height in cm-100), a protein-rich lunch was allowed Week 5-12: replacement of dinner For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.	Dietary supplement: moderate diet regimen; Other Names: protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)
Experimental: stringent diet regimen; Week 1: replacement of 3 main meals by 1g PRMR / kg normal weight (=height in cm - 100) Week 2-4: replacement of breakfast and dinner, a protein-rich lunch was allowed Week 5-12: replacement of dinner For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.	Dietary supplement: stringent diet regimen; Other Names: protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	change in hemoglobin A1c	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	change in hemoglobin A1c	1 year
body weight	change in body weight	12 weeks and 1 year
blood pressure	change in systolic and diastolic blood pressure	12 weeks and 1 year
cholesterol	change in total cholesterol change in HDL cholesterol change in LDL cholesterol	12 weeks and 1 year
fasting blood glucose	change in fastin g blood glucose	12 weeks and 1 year
quality of life	change in SF-36 quality of life questionnaire change in ADS-L (German version of the general depression scale)	12 weeks and 1 year
nutrition	change in FEV (questionnaire for eating manners)	12 weeks and 1 year
physical activity	change in physical activity questionnaire	12 weeks and 1 year
antidiabetic medication	absolute amount of antidiabetic medication; increase or reduction	12 weeks and 1 year

Collaborators and Investigators

• Sponsor: West German Center of Diabetes and Health
• Collaborators: Almased Wellness GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: August 29, 2014
• First Posted (Estimated): September 3, 2014

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: AVS