Trial document
DRKS00005481
Trial Description
Title
Comparison of two formula diets for weight reduction
Trial Acronym
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URL of the Trial
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Brief Summary in Lay Language
Overweight is a major health problem in Germany and other industrialized nations. It promotes the risk of many diseases such as type 2 diabetes, high blood pressure and hardening of the arteries. An integral part of the strategy to the preventive of lifestyle diseases is the reduction of body weight. Proven components in the treatment of obesity are formula diets as meal replacements.
This study examines the effects of a nutritional procedure (protein-rich formula diet or carbohydrate-rich formula diet) in obese persons (body mass index 28-35 kg/m²). In the first two weeks of the study, three meals a day will be replaced by the formula diet. The next two weeks follows the replacement of two meals and finally should be replaced one meal by formula diet per day for four weeks.
Therefore, the goal of this study is to achieve weight reduction in obese people by using formula diets as meal replacements. Additionally to weight reduction the intervention should be associated with improvements in lipid and carbohydrate metabolism.
Brief Summary in Scientific Language
Overweight or obesity is a major and growing health problem in Germany and other industrialized nations. It elevates the risk of many diseases such as type 2 diabetes, hypertension and atherosclerosis. Therefore, an integral part of the strategy with regard to the preventive and therapeutic measures against lifestyle diseases is the reduction of body weight. Established meal replacement strategies using formula diets are used to prevent obesity.
This study examines in terms of nutritional physiology the effects of a nutritional procedure composed of a protein-rich or carbohydrate-rich formula diet, which replaces three meals per day for the first two weeks. The next two weeks follows the replacement of two meals and finally should be replaced one meal by formula diet per day for four weeks.
The goal of the intervention is a general weight reduction and improvements of selected parameters (lipid and glucose metabolism) in obese persons (BMI 28-35 kg/m²). The group which takes the carbohydrate formula diet obtains a non-inferior effect relative to the protein-rich diet.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00005481
- 2013/11/28
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- no
- Approved
- Bo/39/2013, Ethikkommission bei der Ärztekammer Niedersachsen
Secondary IDs
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Health Condition or Problem studied
- E66 - Obesity
Interventions/Observational Groups
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Group 1: intake of protein-rich formula diet
In the first two weeks participants have to replace all three meals a day by the formula diet. The next two weeks follows the replacement of two meals and finally should be replaced one meal by formula diet per day (depending on the daily schedule) for four weeks.
A protein-rich meal replacement consists of two serving spoons (about 34g) of powder and 300 ml low-fat milk and 5 g of vegetable oil. -
Group 2: intake of carbohydrate-rich formula diet
In the first two weeks participants have to replace all three meals a day by the formula diet. The next two weeks follows the replacement of two meals and finally should be replaced one meal by formula diet per day (depending on the daily schedule) for four weeks.
A carbohydrate-rich meal replacement consists of two serving spoons (about 30g) of powder and 300 ml low-fat milk and 5 g of vegetable oil.
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- patient/subject, investigator/therapist
- Active control (effective treament of control group)
- Other
- Parallel
- N/A
- N/A
Primary Outcome
body weight, waist circumference at any appointment (week 0, week 2, week 8, week 20)
Secondary Outcome
body mass index (BMI), Bioelectrical impedance analysis, blood pressure, waist, waist to hip ratio several blood parameters (e.g. glucose, insulin, total cholesterol (TC),high-density-lipoprotein (HDL), low-density-lipoprotein (LDL), triglyceride (TG), Immunological parameters (hsCRP), questionnaire at any appointment (week 0, week 2, week 8, week 20)
Countries of Recruitment
- Germany
Locations of Recruitment
- other
Recruitment
- Actual
- 2014/02/10
- 160
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 30 Years
- 65 Years
Additional Inclusion Criteria
- caucasian men and women at the age of 30-65 years
- Body Mass Index between 28,0 and 35,0 kg/m²
- proband's written agreement to investigation after oral and written education about study content, demands and risks
- proband's willingness to replace one meal by a formula diet and to consume two fatbinding tablets per day
- proband's willingness to follow the given recommendations concerning nutrition and physical acitvity
Exclusion Criteria
- severe chronic illness (manifest coronary heart disease, cancer)
- insulin-dependent diabetes mellitus Typ I and II
- severe kidney or liver diseases
- chronic gastroinestinal diseases (especially small intestine e.g. duodenal ulcer, liver, pancreas) and state after gastrointestinal surgical procedure e.g. nontropical sprue, short bowel syndrome)
- stomach stapling operations, gastric band
- known endokrine and immunological diseases
-Hormonal disorders, for example, hyperthyroidism and Cushing's syndrome
-Treatment with non-insulin-releasing antidiabetics (guar, acarbose)
-Acute potassium-and magnesium-deficient
- lactose or fructose malabsorption
- intolerance towards soy and milk protein
- continuous intake of laxatives
- existing intolerances or allergies to ingredients of the diet (eg nuts, wheat)
- continuous intake of corticosteroids (not inhalation), psychotropic drugs
- pregnancy
- lactation
- addiction to alcohol and/or drugs
- immediate planned surgery
- simultaneous participation at another clinical trial or participation within the last 30 days
- missing consent
- refusing / reset of the consent
Addresses
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start of 1:1-Block address primary-sponsor
- Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
- Mr. Prof. Dr. Andreas Hahn
- Am Kleinen Felde 30
- 30167 Hannover
- Germany
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- http://www.nutrition.uni-hannover.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
- Ms. M.Sc. Katharina Möller
- Am Kleinen Felde 30
- 30167 Hannover
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0511762 - 3317
- 0511/762-5729
- moeller at nutrition.uni-hannover.de
- http://www.nutrition.uni-hannover.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
- Ms. M.Sc. Katharina Möller
- Am Kleinen Felde 30
- 30167 Hannover
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0511/762-3317
- 0511/762-5729
- moeller at nutrition.uni-hannover.de
- http://www.nutrition.uni-hannover.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
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start of 1:1-Block address materialSupport
- Certmedica International GmbH
- Mr. Dr. Kurt Raisch
- Magnolienweg 17
- 63741 Aschaffenburg
- Germany
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Status
- Recruiting complete, follow-up complete
- 2014/07/10
Trial Publications, Results and other Documents
- Möller K, Willers J, Hahn A (2015): Efficacy of high carbohydrate versus high protein meal replacements on weight reduction - a randomized controlled trial, J Obes Weight Loss Ther 5: 266. doi: 10.4172/2165-7904.1000266