Whey Protein Study - Identification of Sustainable Satiety

Sponsor

University of Aberdeen (Other)

Overall Status

Completed

CT.gov ID

NCT02246543

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will have the primary aim to investigate within-day changes in appetite after consumption of high-protein (HP, 30% of calories) and normal, or low, protein (LP, 15% of calories) whey protein meal, in solid and liquid form, on appetite and ad libitum food intake. Secondary objective will be to assess the statistical relationship between plasma concentrations of gut hormones and visual analogue scales (subjective hunger and fullness) and transit time.

In order to investigate the interaction of food structure and protein content on appetite, this requires, in practice, either a differing amount (g) or calorie (kJ) load as a function of energy density (defined as kJ/100g). Delivering the test meal as a solid and liquid form gives an easy solution to achieve this manipulation without compromising the nutritional profile. Following on from this decision, it is easier to produce different preloads using whey protein (rather than meat protein), since it is easily incorporated into test meals.

Condition or Disease	Intervention/Treatment	Phase
Satiety	Dietary Supplement: Control Dietary Supplement: HPL Dietary Supplement: LPL Dietary Supplement: HPS Dietary Supplement: LPS	N/A

Detailed Description

A randomized crossover design in 10 overweight/obese (BMI 26-40) men and 10 lean men (BMI 18.5-25). The control will be water. Each subject will attend the HNU on six separate occasions. The five test meal challenges will involve subjects attending the Human Nutrition Unit (HNU) in the morning, after an overnight fast. The total time of test meal visits will be approximately 4½hours. They will be provided with a standardised meal, after which blood samples will be collected for the first 2hrs. The following five treatments will be tested:

Treatment 1 Control - Water + Egg Yolk Mixture + 13C Octanoic Acid Treatment 2 HPL (High Protein Liquid): 30% protein; 30% fat and 40% carbohydrate (CHO) Treatment 3 LPL (Low Protein Liquid): 15% protein; 30% fat and 55% CHO Treatment 4 HPS (High Protein Solid): 30% protein; 30% fat and 40% CHO Treatment 5 LPS (Low Protein Solid): 15% protein; 30% fat and 55% CHO Test meals will be of fixed nutritional composition for all participants. The liquid meal will be a milk/fruit smoothie mixture and the 'solid' will be in a milk jelly (set) form.

Ad libitum pasta meal: 15% protein; 30% fat and 55% CHO as a homogenous mix and energy density of around 400kJ/100g - served in excess as a individual 600g portion to 'help-yourself'.

Subjective average appetite will be measured (every 30 min by visual analogue scales) over 4hr and ad libitum food intake will measured 4hr after treatment consumption. Ad libitum lunch will be a homogenous pasta meal with tomato sauce and a bottle of water. Blood samples will be collected every 10 min for the first half hour, every 15 min for the second half hour and every 30mins subsequently. The breath gastric emptying measurement will be assessed using the 13Carbon (13C) Octanoic Acid stable isotopic technique19. This involves mixing the tracer into food and taking breath samples and measured by isotope ratio mass spectrometry. 13C Octanoic acid is a medium chain fatty acid which is rapidly absorbed in the duodenum and metabolised in the liver. Following oxidation, the resulting Carbon Dioxide (CO2) is excreted into breath (12 samples will be collected during the 4hr test day).

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Whey Protein Study - Identification of Sustainable Satiety

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Treatment 1 - Control Water, Toast & Egg (Yolk only) + 0.1g 13C Octanoic Acid	Dietary Supplement: Control Water, Toast & Egg (Yolk only) + 0.1g 13C Octanoic Acid
Active Comparator: Treatment 2 - HPL High Protein Smoothie (Liquid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid	Dietary Supplement: HPL High Protein Smoothie (Liquid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid
Active Comparator: Treatment 3 - LPL Low Protein Smoothie (Liquid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid	Dietary Supplement: LPL Low Protein Smoothie (Liquid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid
Active Comparator: Treatment 4 - HPS High Protein Milk Jelly (Solid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid	Dietary Supplement: HPS High Protein Milk Jelly (Solid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid
Active Comparator: Treatment 5 - LPS Low Protein Milk Jelly (Solid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid	Dietary Supplement: LPS Low Protein Milk Jelly (Solid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid

Outcome Measures

Primary Outcome Measures

Changes in postprandial biomarkers of satiety as measured by gut-related hormones [On each test day blood samples are collected every 10 min for the first half hour, every 15 min for the second half hour and every 30mins subsequently. (Eight samples are therefore collected for 2hours at T0, T10, T20, T30, T45, T60, T90 and T120mins)]
The biomarkers to be measured on the Luminex system are Ghrelin (active), Glucagon-like peptide (GLP1), Peptide YY (PYY), Amylin, Leptin & Insulin Biomarkers of Cardiovascular Disease (CVD) risk including total cholesterol, Low Density Lipoprotein Cholesterol (LDL), High Density Lipoprotein (HDL), triglycerides, nonesterified fatty acids (NEFA) will also be measured along with assessment of peripheral glycaemic control, fasting glucose, area under the curve combined with insulin data.

Secondary Outcome Measures

Changes in postprandial gastric emptying, measured using breath samples [On each test day samples are collected every 15mins for the first 2½hrs then every 30mins for the last ½hr. Therefore samples are collected for a total of 3hours at T0, T15, T30, T45, T60, T75, T90, T105, T120, T135, T150 and T180mins.]
This is assessed using the 13C Octanoic Acid stable isotopic technique. A tracer is mixed into food and breath samples are collected which are analysed by isotope ratio mass spectrometry. 13C Octanoic acid is a medium chain fatty acid which is rapidly absorbed in the duodenum and metabolised in the liver. Following oxidation, the resulting CO2 is excreted into breath (12 samples will be collected during the 4hr test day).

Other Outcome Measures

Changes in subjective appetite using visual analogue scales [On each test day the appetite questions are answered every 30mins during the 4hour visit.]
Every 30mins, six appetite questions are answered How hungry do you feel? How full do you feel? How strong is your desire to eat? How much do you think you could eat now How thirsty are you? Preoccupation with thoughts of food?
Ad libitum food intake [Recorded at T240mins on the test day visit and then for approximately 12hours at home. Therefore all food consumed during the 24hours of the test day will be assessed]
To assess if each test breakfast provided has an influence on subsequent meals the consumption of the following are recorded: - Ad libitum pasta meal: 15% protein; 30% fat and 55% CHO as a homogenous mix and energy density of around 400kJ/100g - served in excess at lunchtime as an individual 600g portion to 'help-yourself'. Participants then record all additional meals & snacks consumed at home in a food diary

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

BMI = 18.5-40kg/m2

Exclusion Criteria:

Diabetes
Severe gastrointestinal disorders
Kidney disease
Thromboembolic or coagulation disease
Hepatic disease
Alcohol or any other substance abuse
Gout
Eating disorders
Food allergy
Unregulated thyroid disease
Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders)
Vegetarians & Vegans

Medication Exclusion Criteria:

Orlistat (Xenical)
Oral antidiabetics, insulin
Rimonabant (Acomplia)
Digoxin, anti-arrhythmics
Sibutramine (Reductil)
Tricyclic antidepressants, neuroleptics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rowett Institute of Nutrition & Health, University of Aberdeen	Aberdeen	Aberdeen City	United Kingdom	AB21 9SB

Sponsors and Collaborators

University of Aberdeen

Investigators

Principal Investigator: Alexandra Johnstone, Dr, University of Aberdeen

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Aberdeen

ClinicalTrials.gov Identifier:

NCT02246543

Other Study ID Numbers:

2/033/13
132033

First Posted:

Sep 22, 2014

Last Update Posted:

Mar 24, 2016

Last Verified:

Mar 1, 2016

Keywords provided by University of Aberdeen

Study Results

No Results Posted as of Mar 24, 2016