Whey Protein Study - Identification of Sustainable Satiety

March 23, 2016 updated by: University of Aberdeen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB21 9SB
        • Rowett Institute of Nutrition & Health, University of Aberdeen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in postprandial biomarkers of satiety as measured by gut-related hormones
Time Frame: 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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in postprandial gastric emptying, measured using breath samples
Time Frame: 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).
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in subjective appetite using visual analogue scales
Time Frame: 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?
On each test day the appetite questions are answered every 30mins during the 4hour visit.
Ad libitum food intake
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Investigators

  • Principal Investigator: Alexandra Johnstone, Dr, University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 23, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2/033/13
  • 132033 (Other Identifier: Integrated Research Application System (IRAS))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Satiety

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe