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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01634048
First received: July 2, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Overweight
Obese
Metabolic Syndrome
Non Alcoholic Fatty Liver Disease
Dietary Supplement: High Protein, low calorie meal replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Protein-enriched Diet on Body Composition and Appetite

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Change in lipid content of the liver (intrahepatocellular lipid) [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
    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, gut hormones and food intake. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High protein low calorie meal replacements
Meal replacements with added protein powder(1.34g pro/kg).
Dietary Supplement: High Protein, low calorie meal replacement
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.
Sham Comparator: Normal protein, low calorie meal replacement group
The control group will have standard meal replacements (0.8g protein/kg body weight).
Dietary Supplement: High Protein, low calorie meal replacement
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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01634048

Contacts
Contact: Claire Pettitt 07930331326 c.pettitt@imperial.ac.uk
Contact: Gary Frost, Prof 02083838037 g.frost@imperial.ac.uk

Locations
United Kingdom
Imperial College London Recruiting
London, United Kingdom, W12 0NN
Contact: Claire Pettitt    07930331326      
Contact: Gary Frost, PhD    00442083838037    g.frost@imperial.ac.uk   
Sub-Investigator: Claire Pettitt         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Gary Frost Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01634048     History of Changes
Other Study ID Numbers: 12/LO/0592
Study First Received: July 2, 2012
Last Updated: September 11, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
high protein diet
meal replacements
low calorie diet
intra hepatocellular lipid

Additional relevant MeSH terms:
Fatty Liver
Metabolic Syndrome X
Overweight
Liver Diseases
Digestive System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014