CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
High Protein, low calorie meal replacementdietary
Likely dose
Not stated in record
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Search/NCT01634048
NCT01634048N/ACompleted

The Effect of Protein-enriched Diet on Body Composition and Appetite

Imperial College London·interventional·Posted Jul 6, 2012·Updated Apr 28, 2022

In Brief

A clinical study evaluating High Protein, low calorie meal replacement for Overweight and 3 related conditions. Completed, enrolled 39 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 6, 2012
Enrollment StartJul 1, 2012
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.0 years ago

Interventions

High Protein, low calorie meal replacementdietary

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.