Trial Outcomes & Findings for The Effect of Protein-enriched Diet on Body Composition and Appetite (NCT NCT01634048)

Last Updated: 2022-04-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

Change from Baseline at 12 weeks

Results posted on

2022-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	High Protein Low Calorie Meal Replacements 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.	Normal Protein, Low Calorie Meal Replacement Group 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.
Overall Study STARTED	21	18
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Protein Low Calorie Meal Replacements n=21 Participants 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.	Normal Protein, Low Calorie Meal Replacement Group n=18 Participants 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 n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 9 • n=5 Participants	44 years STANDARD_DEVIATION 14 • n=7 Participants	45 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized White	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Mixed	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United Kingdom	21 participants n=5 Participants	18 participants n=7 Participants	39 participants n=5 Participants
BMI	30.6 kg/m2 STANDARD_DEVIATION 3.0 • n=5 Participants	30.8 kg/m2 STANDARD_DEVIATION 2.4 • n=7 Participants	30.7 kg/m2 STANDARD_DEVIATION 2.7 • n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline at 12 weeks

Outcome measures

Outcome measures
Measure	High Protein Low Calorie Meal Replacements n=13 Participants 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.	Normal Protein, Low Calorie Meal Replacement Group n=11 Participants 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.
Change in Lipid Content of the Liver (Intrahepatocellular Lipid) IHCL Baseline	27.9 % IHCL Standard Error 26.8	9.3 % IHCL Standard Error 5.6
Change in Lipid Content of the Liver (Intrahepatocellular Lipid) IHCL 12 weeks	21.4 % IHCL Standard Error 23.2	5.9 % IHCL Standard Error 5.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Protein Low Calorie Meal Replacements n=10 Participants 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.	Normal Protein, Low Calorie Meal Replacement Group n=12 Participants 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.
Change in Appetite Regulation, Measured by VAS and Food Intake. Energy Intake Baseline	1769 kcal Energy Standard Error 205	1864 kcal Energy Standard Error 156
Change in Appetite Regulation, Measured by VAS and Food Intake. Energy Intake 12 weeks	1369 kcal Energy Standard Error 125	1528 kcal Energy Standard Error 114

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	High Protein Low Calorie Meal Replacements n=15 Participants 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.	Normal Protein, Low Calorie Meal Replacement Group n=15 Participants 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.
Composite Appetite Score AUC (Area Under Curve) Composite Appetite Score (VAS) Baseline	4063 mm*min Standard Deviation 372	3376 mm*min Standard Deviation 372
Composite Appetite Score AUC (Area Under Curve) Composite Appetite Score (VAS) 12 weeks	3728 mm*min Standard Deviation 428	3370 mm*min Standard Deviation 428

Adverse Events

High Protein Low Calorie Meal Replacements

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Protein, Low Calorie Meal Replacement Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Gary Frost

Imperial College

Phone: +44 20 7594 0959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place