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The Effect of Breakfasts Varying in Protein Source on Appetite and Energy Intake

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ClinicalTrials.gov Identifier: NCT02573194
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Anestis Dougkas, Lund University

Tracking Information
First Submitted Date  ICMJE October 8, 2015
First Posted Date  ICMJE October 9, 2015
Last Update Posted Date March 3, 2016
Study Start Date  ICMJE August 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2015)
Changes from baseline in perceived appetite and satiety [ Time Frame: Assessed every 30 min for 240 min and 60 min throughout the day after each of the four breakfasts which are served at least one week apart (4 weeks) ]
The appetite profile is assessed using validated Visual Analogue Scales (VAS) ratings (i.e hunger, fullness, desire to eat, prospective food consumption). The Questionnaires are performed electronically in personal laptops using the Adaptive Visual Analogue Scales (AVAS) software until 240min and in paper form throughout the remaining of the study day.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
  • Voluntary energy intake [ Time Frame: Energy intake is assessed 210 min after the 4 test breakfasts, which are served one week apart.] ]
    Energy intake is assessed by voluntary hot meal ('Pytt I Panna', Swedish hash) provided 210 min after the test puddings, which are given as breakfast. Subjects are instructed to eat only until they feel comfortable satisfied and are given 25min to consume the meal. The total energy consumed is monitored.
  • Appetite and Satiety Hormones [ Time Frame: Assessed at 6 points in time over the morning of each of the 4 test days, which are separated by 1 week (4 weeks)] ]
    Blood samples (2 ml) are collected into edetic acid (EDTA) treated tubes at 0 min (fasted blood sample), 30, 60, 90, 150 and 205 min (i.e. total of 6 samples) over the morning on each test day (separated by 1 week) to quantify the plasma concentrations of circulating appetite regulating hormones and amino acids. Protease inhibitors are added to the samples to reduce protein degradation. All samples are centrifuged at 4 C for 10 min at 2000 g after collection and are separated and stored in cryogenic vials at -80 C.
  • Hedonic Ratings and Palatability of the Test Breakfasts and Meals [ Time Frame: Assessed immediately after consumption of the 4 test puddings and Swedish hash meal (4 weeks) ]
    The palatability and hedonic ratings are assessed using validated Visual Analogue Scales (VAS) ratings (i.e appearance, taste, overall palatability). The Questionnaires are performed electronically in personal laptops using the Adaptive Visual Analogue Scales (AVAS) software.
  • Glucose measurements [ Time Frame: Assessed at 7 points in time over the morning of each of the 4 test days, which are separated by 1 week (4 weeks) ]
    Capillary blood samples are collected by finger-prick at 0 min (fasted blood sample), 30, 45, 60, 90, 150 and 205 min (i.e. total of 7 samples) over the morning on each test day (separated by 1 week) to quantify the glucose concentration using HemoCue Glucose System.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2015)
  • Ad libitum energy intake [ Time Frame: Energy intake is assessed 210 min after the 4 test breakfasts, which are served one week apart.] ]
    Energy intake is assessed by ad libitum hot meal (Pytt I Panna, Swedish hash) provided 210 min after the test puddings, which are given as breakfast. Subjects are instructed to eat only until they feel comfortable satisfied and are given 25min to consume the meal. The total energy consumed is monitored.
  • Appetite and Satiety Hormones [ Time Frame: Assessed at 6 points in time over the morning of each of the 4 test days, which are separated by 1 week (4 weeks)] ]
    Blood samples (2 ml) are collected into EDTA treated tubes at 0 min (fasted blood sample), 30, 60, 90, 150 and 205 min (i.e. total of 6 samples) over the morning on each test day (separated by 1 week) to quantify the plasma concentrations of circulating appetite regulating hormones and amino acids. Protease inhibitors are added to the samples to reduce protein degradation. All samples are centrifuged at 4 C for 10 min at 2000 g after collection and are separated and stored in cryogenic vials at -80 C.
  • Hedonic Ratings and Palatability of the Test Breakfasts and Meals [ Time Frame: Assessed immediately after consumption of the 4 test puddings and Swedish hash meal (4 weeks) ]
    The palatability and hedonic ratings are assessed using validated Visual Analogue Scales (VAS) ratings (i.e apperance, taste, overall palatability). The Questionnaires are performed electronically in personal laptops using the Adaptive Visual Analogue Scales (AVAS) software.
  • Glucose measurements [ Time Frame: Assessed at 7 points in time over the morning of each of the 4 test days, which are separated by 1 week (4 weeks) ]
    Capillary blood samples are collected by finger-prick at 0 min (fasted blood sample), 30, 45, 60, 90, 150 and 205 min (i.e. total of 7 samples) over the morning on each test day (separated by 1 week) to quantify the glucose concentration using HemoCue Glucose System.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Breakfasts Varying in Protein Source on Appetite and Energy Intake
Official Title  ICMJE The Acute Effect of Breakfasts Varying in Protein Source Content on Subjective Appetite Ratings and Voluntary Energy Intake in Healthy Subjects
Brief Summary

Over the last decades, changes in the diet and lifestyle have led to overall energy imbalance becoming commonplace and the emergence of an obesity epidemic with more than 1.6 billion adults being overweight.

Consumption of foods that can affect appetite by increasing satiety could regulate the total energy intake and thus body weight. There is data suggesting that the macronutrient composition of the foods and especially protein content may have a potent role on satiety. However, the type of protein appears to play a role in satiety possibly due to the different balance of the amino acid profile.

The research project is dedicated to identify the source (animal or plant) and the optimized protein quantity needed to accelerate satiation, suppress appetite and extend satiety until hunger appears again.

It is hypothesized that the consumption of animal derived protein-enriched meals will induce a reduction in hunger through the impact on gut hormones and peptides that are closely related to the short-term regulation of food intake.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE Dietary Supplement: Breakfasts varying in protein source content on appetite
In this randomized, within-subject study, subjects are asked to consume 4 iso-energetic and iso-volumetric puddings as breakfast (20% of estimated energy requirements) with varying distribution of protein sources. The objective is to identify the protein source and the distribution on suppressing appetite.
Study Arms  ICMJE
  • Experimental: Animal source of proteins
    Breakfast based on animal proteins: 1700 kJ, 25 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake
    Intervention: Dietary Supplement: Breakfasts varying in protein source content on appetite
  • Experimental: Plant source of proteins
    Breakfast based on plant proteins: 1700 kJ, 25 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake
    Intervention: Dietary Supplement: Breakfasts varying in protein source content on appetite
  • Experimental: Animal and plant source of proteins
    Breakfast based on both animal and plant proteins: 1700 kJ, 25 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake
    Intervention: Dietary Supplement: Breakfasts varying in protein source content on appetite
  • Experimental: Low protein
    Breakfast very low in protein: 1700 kJ, 5 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake
    Intervention: Dietary Supplement: Breakfasts varying in protein source content on appetite
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2016)
28
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2015)
30
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males
  • Age range 18-50 years
  • Normal weight and overweight people as classified by BMI:20-29.9 kg/m2 (inclusive).
  • Weight stable (within 3 kg) two months prior to study inclusion
  • Understanding English well and feeling comfortable speaking it

Exclusion Criteria:

  • Dietary protein consumption >25% energy from protein
  • Had surgery in the previous 12 months
  • Have suffered a myocardial infarction or stroke at any time
  • Suffer from any blood-clotting disorder or prescription of any medication affecting blood clotting
  • Suffer from any metabolic disorders (e.g. diabetes, metabolic syndrome or hypertension)
  • Any requirement to take long-term medication, especially those active on the gastro-intestinal tract or for cardio-vascular disease
  • Any dietary restrictions or recently/currently on a weight reducing diet
  • Irregular eating patterns or not regularly consuming breakfast
  • Food allergies (e.g. milk protein allergies) or intolerances (e.g. lactose)
  • Use of medication which affects food intake or behaviour (e.g. anti-depressants)
  • Use of medication likely to affect taste, smell or appetite
  • Eating restraint based on the three Factor Eating Questionnaire
  • Use of any protein supplements
  • A history of alcohol or drug misuse (the average daily number of units of alcohol considered as acceptable is 2-3 units women; 3-4 units men
  • Smoking
  • Athletes in training (>10 h exercise/week)
  • Female that is breast-feeding, pregnant, or if of child-bearing potential and are not using effective contraceptive precautions
  • Involvement in a study involving an experimental drug/medication within 3 months prior to entry of this study
  • Blood pressure > 160/90 mmHg
  • Vegan or Vegetarian
  • Glucose > 6 mmol/L
  • Gamma glutamyl transpeptidase (liver enzymes) > 1.9 μkat / L
  • Alanine aminotransferase > 1.1 μkat / L
  • Cholesterol > 6.5 mmol/L
  • Triglycerides > 2.0 mmol/L
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02573194
Other Study ID Numbers  ICMJE FHSC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anestis Dougkas, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anestis Dougkas, PhD Lund University
PRS Account Lund University
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP