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

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT01634048
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obese; Metabolic Syndrome; Non Alcoholic Fatty Liver Disease	Dietary Supplement: High Protein, low calorie meal replacement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Protein-enriched Diet on Body Composition and Appetite
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Change in Lipid Content of the Liver (Intrahepatocellular Lipid) [Change from Baseline at 12 weeks]

   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

1. Change in Appetite Regulation, Measured by VAS and Food Intake. [Baseline and 12 weeks]

   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.

Other Outcome Measures

1. Composite Appetite Score AUC (Area Under Curve) [Baseline and 12 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Imperial College London	London		United Kingdom	W12 0NN

Sponsors and Collaborators

• Imperial College London

Investigators

• Principal Investigator: Gary Frost, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT01634048
• Other Study ID Numbers: 12/LO/0592
• First Posted: Jul 6, 2012
• Last Update Posted: Apr 28, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: high protein diet; meal replacements; low calorie diet; intra hepatocellular lipid
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome; Overweight

Study Results

Participant Flow

Arm/Group Title	High Protein Low Calorie Meal Replacements	Normal Protein, Low Calorie Meal Replacement Group
Arm/Group Description	Meal replacements with added protein powder(1.34g pro/kg). 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.	The control group will have standard meal replacements (0.8g protein/kg body weight). 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.
Period Title: Overall Study
STARTED	21	18
COMPLETED	15	15
NOT COMPLETED	6	3

Baseline Characteristics

Arm/Group Title	High Protein Low Calorie Meal Replacements	Normal Protein, Low Calorie Meal Replacement Group	Total
Arm/Group Description	Meal replacements with added protein powder(1.34g pro/kg). 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.	The control group will have standard meal replacements (0.8g protein/kg body weight). 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.	Total of all reporting groups
Overall Participants	21	18	39
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	21 100%	18 100%	39 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (9)	44 (14)	45 (11)
Sex: Female, Male (Count of Participants)
Female	10 47.6%	8 44.4%	18 46.2%
Male	11 52.4%	10 55.6%	21 53.8%
Race/Ethnicity, Customized (Count of Participants)
White	11 52.4%	12 66.7%	23 59%
Asian	3 14.3%	3 16.7%	6 15.4%
Mixed	4 19%	1 5.6%	5 12.8%
Black	1 4.8%	2 11.1%	3 7.7%
Other	2 9.5%	0 0%	2 5.1%
Region of Enrollment (participants) [Number]
United Kingdom	21 100%	18 100%	39 100%
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	30.6 (3.0)	30.8 (2.4)	30.7 (2.7)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Protein Low Calorie Meal Replacements	Normal Protein, Low Calorie Meal Replacement Group
Arm/Group Description	Meal replacements with added protein powder(1.34g pro/kg). 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.	The control group will have standard meal replacements (0.8g protein/kg body weight). 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.
Measure Participants	13	11
IHCL Baseline	27.9 (26.8)	9.3 (5.6)
IHCL 12 weeks	21.4 (23.2)	5.9 (5.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Protein Low Calorie Meal Replacements, Normal Protein, Low Calorie Meal Replacement Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Protein Low Calorie Meal Replacements	Normal Protein, Low Calorie Meal Replacement Group
Arm/Group Description	Meal replacements with added protein powder(1.34g pro/kg). 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.	The control group will have standard meal replacements (0.8g protein/kg body weight). 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.
Measure Participants	10	12
Energy Intake Baseline	1769 (205)	1864 (156)
Energy Intake 12 weeks	1369 (125)	1528 (114)

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Protein Low Calorie Meal Replacements	Normal Protein, Low Calorie Meal Replacement Group
Arm/Group Description	Meal replacements with added protein powder(1.34g pro/kg). 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.	The control group will have standard meal replacements (0.8g protein/kg body weight). 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.
Measure Participants	15	15
Composite Appetite Score (VAS) Baseline	4063 (372)	3376 (372)
Composite Appetite Score (VAS) 12 weeks	3728 (428)	3370 (428)

Adverse Events

Arm/Group Title	High Protein Low Calorie Meal Replacements		Normal Protein, Low Calorie Meal Replacement Group
Arm/Group Description	Meal replacements with added protein powder(1.34g pro/kg). 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.		The control group will have standard meal replacements (0.8g protein/kg body weight). 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.
All Cause Mortality
	High Protein Low Calorie Meal Replacements		Normal Protein, Low Calorie Meal Replacement Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	High Protein Low Calorie Meal Replacements		Normal Protein, Low Calorie Meal Replacement Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	High Protein Low Calorie Meal Replacements		Normal Protein, Low Calorie Meal Replacement Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.