ObesityNCT02573194
The Effect of Breakfasts Varying in Protein Source on Appetite and Energy Intake
A study testing Breakfasts varying in protein source content on appetite in people with Obesity, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Breakfasts varying in protein source content on appetite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effect of Breakfasts Varying in Protein Source Content on Subjective Appetite Ratings and Voluntary Energy Intake in Healthy Subjects
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.
Read more
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.
- Conditions
- Obesity
- Being tested
- Breakfasts varying in protein source content on appetite
- Keywords
- Appetite, Amino acids, Protein Source
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfasts varying in protein source content on appetiteDietary supplement
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 group | Role | What they receive |
|---|---|---|
| Animal source of proteins | Experimental | Breakfast based on animal proteins: 1700 kJ, 25 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake Receives: Dietary Supplement: Breakfasts varying in protein source content on appetite |
| Plant source of proteins | Experimental | Breakfast based on plant proteins: 1700 kJ, 25 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake Receives: Dietary Supplement: Breakfasts varying in protein source content on appetite |
| Animal and plant source of proteins | Experimental | 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 Receives: Dietary Supplement: Breakfasts varying in protein source content on appetite |
| Low protein | Experimental | Breakfast very low in protein: 1700 kJ, 5 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake Receives: Dietary Supplement: Breakfasts varying in protein source content on appetite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in perceived appetite and satiety
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.
Measured: 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)
Secondary outcomes (4)
Voluntary energy intake
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.
Measured: Energy intake is assessed 210 min after the 4 test breakfasts, which are served one week apart.]
Appetite and Satiety Hormones
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.
Measured: Assessed at 6 points in time over the morning of each of the 4 test days, which are separated by 1 week (4 weeks)]
Hedonic Ratings and Palatability of the Test Breakfasts and Meals
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.
Measured: Assessed immediately after consumption of the 4 test puddings and Swedish hash meal (4 weeks)
Glucose measurements
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.
Measured: Assessed at 7 points in time over the morning of each of the 4 test days, which are separated by 1 week (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anestis Dougkas, Lund University
- Investigators
- Anestis Dougkas, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573194
- Sponsor's protocol ID
- FHSC
- Status last verified
- Mar 2016
- First submitted
- 8 Oct 2015
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Breakfasts Varying in Protein Source Content on Subjective Appetite Ratings and Voluntary Energy Intake in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02573194
- Acronym / sponsor ID
- FHSC
- Conditions
- Obesity
- Keywords
- Appetite, Amino acids, Protein Source
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Animal source of proteins | Experimental | Dietary Supplement: Breakfasts varying in protein source content on appetiteBreakfast based on animal proteins: 1700 kJ, 25 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake |
| Plant source of proteins | Experimental | Dietary Supplement: Breakfasts varying in protein source content on appetiteBreakfast based on plant proteins: 1700 kJ, 25 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake |
| Animal and plant source of proteins | Experimental | Dietary Supplement: Breakfasts varying in protein source content on appetiteBreakfast 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 |
| Low protein | Experimental | Dietary Supplement: Breakfasts varying in protein source content on appetiteBreakfast very low in protein: 1700 kJ, 5 E% Protein Acute effect of breakfasts varying in protein source content on appetite and energy intake |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfasts varying in protein source content on appetiteIn 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. | Dietary supplement | Animal and plant source of proteins, Animal source of proteins, Low protein, Plant source of proteins |
Primary outcome
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.
4 secondary outcomes
Voluntary energy intake
Time frame: Energy intake is assessed 210 min after the 4 test breakfasts, which are served one week apart.]
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)]
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anestis Dougkas, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfasts varying in protein source content on appetite in people with Obesity, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.