Back to resultsThe Effect of Protein-enriched Diet on Body Composition and Appetite (ProteinRich)
Primary Purpose
Overweight, Obese, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High Protein, low calorie meal replacement
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring high protein diet, meal replacements, low calorie diet, intra hepatocellular lipid
Eligibility Criteria
Inclusion Criteria:
- Overweight and obese people as classified by BMI 27-35kg/ m2 (inclusive)
- A Finnish Diabetes Risk Score (FINDRISC) >8 [22]
- Waist circumference measurement of ≥102cm in males or ≥88cm in females
- Assessed as appropriate for inclusion, based on a prestudy screening (see section 3.4)
- Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements
Exclusion Criteria:
- Claustrophobia
- Pacemaker, metal implant, clips, implanted device, shrapnel or bullets, metal in eyes that precludes magnetic resonance imaging
- Treatment with any medication that might affect the study outcome (e.g., medication that is affecting appetite regulation and/or blood flow)
- Current pregnancy or breast feeding
- Delivery within the last year
- Bariatric surgery
- History of any disease with unknown outcome
- Significant intercurrent disease or history of clinically significant disease of any type, in particular liver, kidney, or heart disease, any form of diabetes mellitus or psychiatric illness (including Depression as defined by BDIII score above 28)
- History of cancer, excluding skin cancer
- History of severe or multiple allergies, severe adverse drug reaction or leucopenia
- Smokers
- Regular drinkers of more than three units of alcohol daily (1 unit = 300 ml beer, 1 glass wine, 1 measure spirit)
- Subjects who have had a fluctuation of body weight >5% in the 3 months prior to entering into the study
- History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit
- Regular intake of overthecounter (OTC) medication (other than the occasional paracetamol/aspirin)
- Poor compliers or subjects unlikely to attend
- Blood donation within the 12 week period before the initial study dose
Sites / Locations
- Imperial College London
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
High protein low calorie meal replacements
Normal protein, low calorie meal replacement group
Arm Description
Meal replacements with added protein powder(1.34g pro/kg).
The control group will have standard meal replacements (0.8g protein/kg body weight).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Appetite Regulation, Measured by VAS and Food Intake.
It has also been suggested that highprotein diets are more beneficial in the regulation of appetite. We therefore aim to measure any changes in appetite whilst on a highprotein lowenergy diet compared to a normalprotein lowenergy diet. Changes in appetite will be measured using validated questionnaires assessing subjects feeling of hunger, pleasantness and volume able to eat as well as fullness. This data may support our hypothesis that highprotein intakes may alter appetite regulation and therefore be a useful in the treatment of obesity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01634048
Brief Title
The Effect of Protein-enriched Diet on Body Composition and Appetite
Acronym
ProteinRich
Official Title
The Effect of Protein-enriched Diet on Body Composition and Appetite
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese, Metabolic Syndrome, Non Alcoholic Fatty Liver Disease
Keywords
high protein diet, meal replacements, low calorie diet, intra hepatocellular lipid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High protein low calorie meal replacements
Arm Type
Experimental
Arm Description
Meal replacements with added protein powder(1.34g pro/kg).
Arm Title
Normal protein, low calorie meal replacement group
Arm Type
Sham Comparator
Arm Description
The control group will have standard meal replacements (0.8g protein/kg body weight).
Intervention Type
Dietary Supplement
Intervention Name(s)
High Protein, low calorie meal replacement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Lipid Content of the Liver (Intrahepatocellular Lipid)
Description
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.
Time Frame
Change from Baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Change in Appetite Regulation, Measured by VAS and Food Intake.
Description
It has also been suggested that highprotein diets are more beneficial in the regulation of appetite. We therefore aim to measure any changes in appetite whilst on a highprotein lowenergy diet compared to a normalprotein lowenergy diet. Changes in appetite will be measured using validated questionnaires assessing subjects feeling of hunger, pleasantness and volume able to eat as well as fullness. This data may support our hypothesis that highprotein intakes may alter appetite regulation and therefore be a useful in the treatment of obesity.
Time Frame
Baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Composite Appetite Score AUC (Area Under Curve)
Description
A composite appetite score was calculated combing all four appetite measures to give a summary measure of appetite. Each appetite measure was assessed using validated 100 mm visual analogue scales (VAS) for hunger, fullness, desire to eat, and prospective food consumption (PFC) with the most positive and most negative sensations anchoring opposite ends of the line, from 'Not at all' or 'Nothing' to 'Extremely' or 'A large amount'. Participants were asked to mark the line at the point corresponding to their perceived appetite at that time. There is no score which is better or worse.
Composite Appetite score (mm min) = [desire to eat + hunger + (100 - fullness) + prospective consumption]/4, as described by (Anderson et al, 2002). This reflects the four appetite related VAS (visual analogue scale) questions and was used as a summary measure of appetite. Area Under the Curve (AUC) was calculated for composite appetites score using the trapezoidal rule. AUC scores range from 0-9000mm*min
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Overweight and obese people as classified by BMI 27-35kg/ m2 (inclusive)
A Finnish Diabetes Risk Score (FINDRISC) >8 [22]
Waist circumference measurement of ≥102cm in males or ≥88cm in females
Assessed as appropriate for inclusion, based on a prestudy screening (see section 3.4)
Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements
Exclusion Criteria:
Claustrophobia
Pacemaker, metal implant, clips, implanted device, shrapnel or bullets, metal in eyes that precludes magnetic resonance imaging
Treatment with any medication that might affect the study outcome (e.g., medication that is affecting appetite regulation and/or blood flow)
Current pregnancy or breast feeding
Delivery within the last year
Bariatric surgery
History of any disease with unknown outcome
Significant intercurrent disease or history of clinically significant disease of any type, in particular liver, kidney, or heart disease, any form of diabetes mellitus or psychiatric illness (including Depression as defined by BDIII score above 28)
History of cancer, excluding skin cancer
History of severe or multiple allergies, severe adverse drug reaction or leucopenia
Smokers
Regular drinkers of more than three units of alcohol daily (1 unit = 300 ml beer, 1 glass wine, 1 measure spirit)
Subjects who have had a fluctuation of body weight >5% in the 3 months prior to entering into the study
History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit
Regular intake of overthecounter (OTC) medication (other than the occasional paracetamol/aspirin)
Poor compliers or subjects unlikely to attend
Blood donation within the 12 week period before the initial study dose
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Frost
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Protein-enriched Diet on Body Composition and Appetite
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