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

NCT01634048 | Completed Results DMC

• 1 other identifier: 12/LO/0592
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obese; Metabolic Syndrome; Non Alcoholic Fatty Liver Disease

Keywords

high protein diet; meal replacements; low calorie diet; intra hepatocellular lipid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Appetite Regulation, Measured by VAS and Food Intake.

  Baseline and 12 weeks

Other Outcomes (1)

• Composite Appetite Score AUC (Area Under Curve)

  Baseline and 12 weeks

Study Arms (2)

High protein low calorie meal replacements

EXPERIMENTAL

Meal replacements with added protein powder(1.34g pro/kg).

Dietary Supplement: High Protein, low calorie meal replacement

Normal protein, low calorie meal replacement group

SHAM COMPARATOR

The control group will have standard meal replacements (0.8g protein/kg body weight).

Dietary Supplement: High Protein, low calorie meal replacement

Interventions

High Protein, low calorie meal replacement DIETARY_SUPPLEMENT

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.

High protein low calorie meal replacements; Normal protein, low calorie meal replacement group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements

You may not qualify if:

• 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)

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Professor Gary Frost
• Organization: Imperial College

g.frost@imperial.ac.uk

+44 20 7594 0959

Study Officials

• Gary Frost

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 6, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 28, 2022
• Results First Posted: October 12, 2021

Record last verified: 2022-04

Locations

GB (1)