Dietary ModificationNCT02811276
The Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism
A study testing Diet in people with Dietary Modification, run by University of Alberta at 1 site in Canada.
Trial summary
In the 19th century, researchers found out that the differences in the energy content of macronutrients (protein, carbohydrate and fat) can elicit different responses in the amount of calories individuals burn per day. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Mar 2018
- 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 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy;
- Non-smoker;
- Female;
- Aged 18 to 34.9 years;
- Body mass index (BMI) between 18.5 and 24.9 kg/m² (preferably between 20 and 24.9 kg/m²);
- Regular menstrual cycle (lasting between 25 and 35 days).
Who cannot join
- Have previously been diagnosed with any kind of disease;
- Are taking any medications which may alter energy metabolism or body composition;
- Are lactose, gluten and/or soy allergic/intolerant;
- Follow a vegetarian, vegan or restrictive dietary pattern;
- Are pregnant or lactating;
- Have used nutritional supplements in the past two months;
Show all 10Show fewer
- Perform over an hour per day of leisure time physical activity or more than seven hours per week of strenuous activity;
- Have had a nuclear medicine scan or injection of an X-ray dye in the past week;
- Have had a barium test/exam in the last two weeks;
- Claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Cross-over Trial Investigating the Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism in Healthy Women
In the 19th century, researchers found out that the differences in the energy content of macronutrients (protein, carbohydrate and fat) can elicit different responses in the amount of calories individuals burn per day. It was demonstrated that protein has a metabolic advantage when compared to the other macronutrients (carbohydrate and fat). Since these findings, researchers all over the world started to study how diets differing in macronutrient distribution could result in different responses to energy metabolism. Diets with high amounts of protein (i.e. meats, eggs, dairy products, and grains) are becoming more popular, and studies have shown that when people eat high quantities of protein they lose weight and fat mass, maintain the weight loss, and burn more calories per day.
The investigators hypothesize that giving high amounts of protein to healthy women will increase the amount of calories and fat they burn per day, increase their satiety, and improve health markers when compared to a normal diet. The increased protein level will be achieved using a nutrition supplement consisted of soy protein, yogurt and honey.
To test this, the investigators plan to divide the participants in two groups: one will eat a normal diet and the other a diet with high amounts of protein during one and a half day. After one month they will change groups and eat the other diet for the same period of time. During this period consuming the diets (1.5 days), participants will stay inside a whole body calorimetry suite, which is similar to a hotel bedroom and is able to inform in the most precise way the amount of calories participants will burn and if they are burning more fat. Additionally, before and after each meal participants will have to answer a questionnaire about their appetite sensations and blood will also be collected to analyze health markers.
Read the detailed description
The aim of this study is to investigate the impact of a high protein diet (achieved through the use of a high protein supplement) versus standard diet on substrate oxidation and energy expenditure using a state-of-the-art live-in whole body calorimetry unit (WBCU).
This study will be an acute randomized, controlled, cross-over trial. Healthy women (n=24) will receive a run-in diet for three days and will then be randomly allocated into one of the following groups: 1) Control group receiving an eucaloric standard diet (55% of carbohydrate, 15% of protein, and 30% of lipid); 2) High-protein group: eucaloric high protein diet (35% of carbohydrate, 40% of protein, and 25% of fat) constructed around a soy protein-based meal replacement. The wash-out period will be of approximately one month. While receiving the diets in the WBCU for 32 hours, participants' overall change in energy metabolism including respiratory quotient will be assessed. Additional assessments include metabolic blood markers (glucose, insulin, lipid panel, peptide tyrosine-tyrosine, ghrelin, leptin, free glycerol, and free fatty acids), and appetite sensations (hunger and satiety). Body composition and energy requirements will be assessed at baseline using dual-energy X-ray absorptiometry and indirect calorimetry, respectively.
It is expected that the high-protein diet will increase lipid oxidation, and energy expenditure, with other favorable changes in the additional markers when compared to the control group.
- Conditions
- Dietary Modification
- Being tested
- Diet
- Keywords
- High-protein diet, Energy metabolism, Substrate oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
The High-Protein Diet Group will receive a eucaloric diet composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement (Almased®) for one and a half day. Participants will consume 1 gram ± 0.1 of Almased® per kg of body weight mixed with linseed oil and skim milk in their breakfast, lunch and dinner. Two snacks (afternoon and evening) composed of 1 gram ± 0.1 of Almased® per kg of body weight mixed with vegetable juice and linseed oil will also be provided.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Those assigned to the Control Group will receive a eucaloric diet (a diet designed to meet the person's energy needs and maintain body weight) composed of 55% of carbohydrate, 15% of protein, and 30% of lipid. |
| High-Protein Diet Group | Experimental | Those assigned to the High-Protein Diet Group will receive a eucaloric diet composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement (Almased®). Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in fat balance assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.
To measure the differences in fat balance during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.
Measured: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
Secondary outcomes (1)
Difference in 24-hour energy expenditure assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.
To measure the differences in 24-hour energy expenditure during 32 hours of a high-protein (HP) total diet replacement compared to 32 hours of a control (CON) diet.
Measured: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Almased Wellness GmbH
- Responsible party
- Principal investigator, Carla Prado, University of Alberta
- Investigators
- Carla MM Prado, PhD, Principal investigator, University of AlbertaArya Sharma, PhD, Principal investigator, Unviersity of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811276
- Sponsor's protocol ID
- Pro00066006
- Status last verified
- Aug 2019
- First submitted
- 16 Jun 2016
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Oliveira CLP, Boule NG, Elliott SA, Sharma AM, Siervo M, Berg A, Ghosh S, Prado CM. A high-protein total diet replacement alters the regulation of food intake and energy homeostasis in healthy, normal-weight adults. Eur J Nutr. 2022 Jun;61(4):1849-1861. doi: 10.1007/s00394-021-02747-1. Epub 2021 Dec 20.
PubMed 34928408Oliveira CLP, Boule NG, Sharma AM, Elliott SA, Siervo M, Ghosh S, Berg A, Prado CM. A high-protein total diet replacement increases energy expenditure and leads to negative fat balance in healthy, normal-weight adults. Am J Clin Nutr. 2021 Feb 2;113(2):476-487. doi: 10.1093/ajcn/nqaa283.
PubMed 33247306Oliveira CLP, Boule NG, Sharma AM, Elliott S, Siervo M, Ghosh S, Berg A, Prado CM. Examining the effects of a high-protein total diet replacement on energy metabolism, metabolic blood markers, and appetite sensations in healthy adults: protocol for two complementary, randomized, controlled, crossover trials. Trials. 2019 Dec 27;20(1):787. doi: 10.1186/s13063-019-3950-y.
PubMed 31881910
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Cross-over Trial Investigating the Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism in Healthy Women
- ClinicalTrials.gov ID
- NCT02811276
- Acronym / sponsor ID
- Pro00066006
- Conditions
- Dietary Modification
- Keywords
- High-protein diet, Energy metabolism, Substrate oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Almased Wellness GmbH
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 23 Jun 2016 (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.
In the 19th century, researchers found out that the differences in the energy content of macronutrients (protein, carbohydrate and fat) can elicit different responses in the amount of calories individuals burn per day. It was demonstrated that protein has a metabolic advantage when compared to the other macronutrients (carbohydrate and fat). Since these findings, researchers all over the world started to study how diets differing in macronutrient distribution could result in different responses to energy metabolism. Diets with high amounts of protein (i.e. meats, eggs, dairy products, and grains) are becoming more popular, and studies have shown that when people eat high quantities of protein they lose weight and fat mass, maintain the weight loss, and burn more calories per day.
The investigators hypothesize that giving high amounts of protein to healthy women will increase the amount of calories and fat they burn per day, increase their satiety, and improve health markers when compared to a normal diet. The increased protein level will be achieved using a nutrition supplement consisted of soy protein, yogurt and honey.
To test this, the investigators plan to divide the participants in two groups: one will eat a normal diet and the other a diet with high amounts of protein during one and a half day. After one month they will change groups and eat the other diet for the same period of time. During this period consuming the diets (1.5 days), participants will stay inside a whole body calorimetry suite, which is similar to a hotel bedroom and is able to inform in the most precise way the amount of calories participants will burn and if they are burning more fat. Additionally, before and after each meal participants will have to answer a questionnaire about their appetite sensations and blood will also be collected to analyze health markers.
Detailed description
The aim of this study is to investigate the impact of a high protein diet (achieved through the use of a high protein supplement) versus standard diet on substrate oxidation and energy expenditure using a state-of-the-art live-in whole body calorimetry unit (WBCU).
This study will be an acute randomized, controlled, cross-over trial. Healthy women (n=24) will receive a run-in diet for three days and will then be randomly allocated into one of the following groups: 1) Control group receiving an eucaloric standard diet (55% of carbohydrate, 15% of protein, and 30% of lipid); 2) High-protein group: eucaloric high protein diet (35% of carbohydrate, 40% of protein, and 25% of fat) constructed around a soy protein-based meal replacement. The wash-out period will be of approximately one month. While receiving the diets in the WBCU for 32 hours, participants' overall change in energy metabolism including respiratory quotient will be assessed. Additional assessments include metabolic blood markers (glucose, insulin, lipid panel, peptide tyrosine-tyrosine, ghrelin, leptin, free glycerol, and free fatty acids), and appetite sensations (hunger and satiety). Body composition and energy requirements will be assessed at baseline using dual-energy X-ray absorptiometry and indirect calorimetry, respectively.
It is expected that the high-protein diet will increase lipid oxidation, and energy expenditure, with other favorable changes in the additional markers when compared to the control group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Those assigned to the Control Group will receive a eucaloric diet (a diet designed to meet the person's energy needs and maintain body weight) composed of 55% of carbohydrate, 15% of protein, and 30% of lipid. |
| High-Protein Diet Group | Experimental | Other: DietThose assigned to the High-Protein Diet Group will receive a eucaloric diet composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement (Almased®). |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy;
- Non-smoker;
- Female;
- Aged 18 to 34.9 years;
- Body mass index (BMI) between 18.5 and 24.9 kg/m² (preferably between 20 and 24.9 kg/m²);
Key exclusion criteria (10 listed)
- Have previously been diagnosed with any kind of disease;
- Are taking any medications which may alter energy metabolism or body composition;
- Are lactose, gluten and/or soy allergic/intolerant;
- Follow a vegetarian, vegan or restrictive dietary pattern;
- Are pregnant or lactating;
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 |
|---|---|---|
| DietThe High-Protein Diet Group will receive a eucaloric diet composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement (Almased®) for one and a half day. Participants will consume 1 gram ± 0.1 of Almased® per kg of body weight mixed with linseed oil and skim milk in their breakfast, lunch and dinner. Two snacks (afternoon and evening) composed of 1 gram ± 0.1 of Almased® per kg of body weight mixed with vegetable juice and linseed oil will also be provided. | Other | High-Protein Diet Group |
Primary outcome
Difference in fat balance assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.
Time frame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
To measure the differences in fat balance during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.
1 secondary outcome
Difference in 24-hour energy expenditure assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.
Time frame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.
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 28 Aug 2019.
- Derived from this study: PubMed 34928408Oliveira CLP, Boule NG, Elliott SA, Sharma AM, Siervo M, Berg A, Ghosh S, Prado CM. A high-protein total diet replacement alters the regulation of food intake and energy homeostasis in healthy, normal-weight adults. Eur J Nutr. 2022 Jun;61(4):1849-1861. doi: 10.1007/s00394-021-02747-1. Epub 2021 Dec 20.
- Derived from this study: PubMed 33247306Oliveira CLP, Boule NG, Sharma AM, Elliott SA, Siervo M, Ghosh S, Berg A, Prado CM. A high-protein total diet replacement increases energy expenditure and leads to negative fat balance in healthy, normal-weight adults. Am J Clin Nutr. 2021 Feb 2;113(2):476-487. doi: 10.1093/ajcn/nqaa283.
- Derived from this study: PubMed 31881910Oliveira CLP, Boule NG, Sharma AM, Elliott S, Siervo M, Ghosh S, Berg A, Prado CM. Examining the effects of a high-protein total diet replacement on energy metabolism, metabolic blood markers, and appetite sensations in healthy adults: protocol for two complementary, randomized, controlled, crossover trials. Trials. 2019 Dec 27;20(1):787. doi: 10.1186/s13063-019-3950-y.
- Individual participant dataSharing planned: No
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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.
Carla MM Prado, PhD principal investigator
University of Alberta
Arya Sharma, PhD principal investigator
Unviersity of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Dietary Modification, run by University of Alberta at 1 site in Canada.
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 6 inclusion and 10 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 28 Aug 2019. 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 Canada. 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?
Difference in fat balance assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet. (time frame: During a 32-hour period while receiving a HP total diet replacement or a CON diet.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02811276, which also lists 3 linked publications.
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 28 Aug 2019.