Dietary Modification Clinical Trial
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
NCT number | NCT02811276 |
Other study ID # | Pro00066006 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | March 2018 |
Verified date | August 2019 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 34 Years |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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; - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Almased Wellness GmbH |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in appetite sensations assessed by a 100 mm visual analogue scale questionnaire. | Changes in hunger, satiety, fullness, and prospective food consumption will be rated by participants on a 100 mm visual analogue scale immediately before and 30 minutes after each meal and snack provided while participants spend 32 hours inside the whole body calorimetry unit while receiving a high-protein diet or a control diet. The 100 mm visual analogue scale is administered using the paper-and-pen method and participants are instructed to make a single vertical mark at the appropriate point between the two anchors on each scale to indicate the intensity of their subjective states regarding each element (between 0 and 100 mm): Hunger: 0 mm = "I am not hungry at all"; 100 mm = "I have never been more hungry". Satiety: 0 mm = "I am completely empty"; 100 mm = "I cannot eat another bite". Fullness: 0 mm = "Not at all full"; 100 mm = "Totally full". Prospective food consumption: 0 mm = "Nothing at all"; 100 mm = "A lot". |
During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Changes in blood glucose levels. | Changes in glucose will be assessed four times (fasting on the first day - at 07:45 a.m.; after the exercise session on the first day - at 11:00 a.m.; two hours postprandial on the first day - at 02:30 p.m.; fasting on the second day - at 08:30 a.m.) while participants spend 32 hours inside the whole body calorimetry unit while receiving a high-protein diet or a control diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Changes in blood insulin levels. | Changes in insulin will be assessed four times (fasting on the first day - at 07:45 a.m.; after the exercise session on the first day - at 11:00 a.m.; two hours postprandial on the first day - at 02:30 p.m.; fasting on the second day - at 08:30 a.m.) while participants spend 32 hours inside the whole body calorimetry unit while receiving a high-protein diet or a control diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Changes in blood lipid panel levels. | Changes in lipid panel will be assessed four times (fasting on the first day - at 07:45 a.m.; after the exercise session on the first day - at 11:00 a.m.; two hours postprandial on the first day - at 02:30 p.m.; fasting on the second day - at 08:30 a.m.) while participants spend 32 hours inside the whole body calorimetry unit while receiving a high-protein diet or a control diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Changes in blood peptide tyrosine-tyrosine levels. | Changes in peptide tyrosine-tyrosine will be assessed four times (fasting on the first day - at 07:45 a.m.; after the exercise session on the first day - at 11:00 a.m.; two hours postprandial on the first day - at 02:30 p.m.; fasting on the second day - at 08:30 a.m.) while participants spend 32 hours inside the whole body calorimetry unit while receiving a high-protein diet or a control diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Changes in blood glucagon-like peptide-1 levels. | Changes in glucagon-like peptide-1 will be assessed four times (fasting on the first day - at 07:45 a.m.; after the exercise session on the first day - at 11:00 a.m.; two hours postprandial on the first day - at 02:30 p.m.; fasting on the second day - at 08:30 a.m.) while participants spend 32 hours inside the whole body calorimetry unit while receiving a high-protein diet or a control diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Changes in blood ghrelin levels. | Changes in ghrelin will be assessed four times (fasting on the first day - at 07:45 a.m.; after the exercise session on the first day - at 11:00 a.m.; two hours postprandial on the first day - at 02:30 p.m.; fasting on the second day - at 08:30 a.m.) while participants spend 32 hours inside the whole body calorimetry unit while receiving a high-protein diet or a control diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Changes in blood leptin levels. | Changes in leptin will be assessed four times (fasting on the first day - at 07:45 a.m.; after the exercise session on the first day - at 11:00 a.m.; two hours postprandial on the first day - at 02:30 p.m.; fasting on the second day - at 08:30 a.m.) while participants spend 32 hours inside the whole body calorimetry unit while receiving a high-protein diet or a control diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Changes in blood free glycerol levels. | Changes in glycerol will be assessed four times (fasting on the first day - at 07:45 a.m.; after the exercise session on the first day - at 11:00 a.m.; two hours postprandial on the first day - at 02:30 p.m.; fasting on the second day - at 08:30 a.m.) while participants spend 32 hours inside the whole body calorimetry unit while receiving a high-protein diet or a control diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Changes in blood free fatty acids levels. | Changes in free fatty acids will be assessed four times (fasting on the first day - at 07:45 a.m.; after the exercise session on the first day - at 11:00 a.m.; two hours postprandial on the first day - at 02:30 p.m.; fasting on the second day - at 08:30 a.m.) while participants spend 32 hours inside the whole body calorimetry unit while receiving a high-protein diet or a control diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Difference in 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 selected components of energy expenditure (resting, basal, sleep and postprandial - kcal) during 32 hours of a high-protein (HP) total diet replacement compared to 32 hours of a control (CON) diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Difference in substrate oxidation 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 substrate oxidation rates (carbohydrate and protein - grams per day) during 32 hours of a high-protein (HP) total diet replacement compared to 32 hours of a control (CON) diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Other | Difference in substrate 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 substrate balance (carbohydrate and protein - grams per day) during 32 hours of a high-protein (HP) total diet replacement compared to 32 hours of a control (CON) diet. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Primary | 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. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. | |
Secondary | 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. | During a 32-hour period while receiving a HP total diet replacement or a CON diet. |
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