The Effect of Protein-enriched Diet on Body Composition and Appetite
ProteinRich
Sponsor study identifier
interventional
39
1 country
1
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Obesity is a major problem worldwide and current dietary interventions are not proving to be enough to cease the increase in levels of obesity and its detrimental side effects, such as nonalcoholic fatty liver disease (NAFLD). Existing data suggests that adjustments in the macronutrient composition of the diet, more specifically the protein content, may have beneficial effects on body composition and an antiobesegenic effect on appetite. This may be important in terms of controlling body weight and reducing the amount of fatty tissue within our bodies and organs, and therefore preventing obesity and its health related side effects. The investigators will perform a study to investigate whether a high protein low energy diet compared to a normal protein low energy diet, in overweight adults can modify appetite and aid loss of weight and fat mass. Subjects will receive either a high protein low energy diet (1.34g protein/kg body weight) or a normal protein low energy diet (0.8g protein/kg body weight) in the form of 2 meal replacements and one conventional meal per day with 2 snacks for 12 weeks. HYPOTHESIS In overweight subjects with the metabolic syndrome, a 12 week dietary intervention with a high protein low energy diet will lead to a reduced appetite, body weight and fat mass, more specifically to a greater fall in levels of fat in the liver and pancreas than a low energy normal protein diet.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 2, 2012
Actual (reported)July 6, 2012
Actual (reported)May 2015
Actual (reported)May 2015
Actual (reported)October 12, 2021
Actual (reported)Change in Lipid Content of the Liver (Intrahepatocellular Lipid)
Changes in body weight and body composition, more specifically visceral, muscle, liver and pancreas fat content will be measured using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). Individual's data will be compared at baseline and at 12 weeks of following the diet and also to that of the participants given normal protein low energy diets. This data may therefore support our hypothesis that high protein intakes may help to aid weight loss and reduce fat mass and would therefore be a viable option in the treatment of obesity.
Change from Baseline at 12 weeks
Change in Appetite Regulation, Measured by VAS and Food Intake.
Baseline and 12 weeks
Meal replacements with added protein powder(1.34g pro/kg).
The control group will have standard meal replacements (0.8g protein/kg body weight).
The high protein group will have meal replacements with added protein powder (to achieve 1.34g protein/kg body weight) and the control group will have standard meal replacements (0.8g protein/kg body weight). Meal replacements have been used in hundreds of previous human studies and are generally not found to be linked to any serious adverse effects.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Imperial College London
London, W12 0NN, United Kingdom
Gary Frost
Imperial College London
39 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2012
First Posted
July 6, 2012
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Foundations for Health
Composite Appetite Score AUC (Area Under Curve)
Baseline and 12 weeks
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Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
April 28, 2022
Results First Posted
October 12, 2021
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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