ObesityEgg_breakfastNCT03085511
High Quality Protein for Assisting With Weight Loss
A study testing Egg breakfast (EB), Weight Loss Counseling and Weight Loss Diet in people with Obesity, run by Texas Tech University at 1 site in United States.
Trial summary
The purpose of this study is to determine if, in presence of a reduced calorie diet, a breakfast containing high quality protein source (eggs) would be more effective in reducing hunger and increasing feeling of fullness compared to a breakfast containing a lower quality of protein, but equal energy density. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Egg breakfast (EB), Weight Loss Counseling and Weight Loss Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2017to 17 May 2019
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight and class I-II obese (BMI 25.0-39.9)
- Sedentary (<3 hours/week of moderate intensity physical activity)
- Otherwise healthy
Who cannot join
- ≥5% body weight loss or gain in the three months preceding the study
- Post-menopausal (has not had period for 12 months)
- Plans to begin an exercise program or change current exercise routines between initiation of study and final study
- Anyone following a medical diet prescription
- Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type
- Health conditions and chronic illness that contraindicate behavioral weight loss treatment using a low calorie diet: Unstable cardiac condition; Polycystic ovary syndrome; Prader-Willi syndrome; Major systemic illness; History of recreational drug abuse or eating disorder (Binge Eating Disorder); Familial hyperlipidemia; Major endocrine diseases (Cushing's syndrome, Grave's disease, Hashimoto's thyroiditis); Gastrointestinal disorder
Show all 14Show fewer
- Anyone who is currently pregnant, or lactating
- Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling
- Plans to begin taking any supplements that may influence weight loss
- Report of medical condition or surgical intervention that affects swallowing or chewing ability
- Anyone with a pacemaker or other internal medical device
- Any practicing vegans or vegetarians
- Any practicing gluten-free diet
- Allergy, aversion, or dislike to any of the foods offered for meals
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University - Department of Nutritional Sciences
Lubbock, Texas, 79409
About this study
Official title: Does Higher Protein Quality Reduce Energy Intake When Following a Weight Loss Diet Plan? -- Nonpilot, Powered Crossover
The purpose of this study is to determine if, in presence of a reduced calorie diet, a breakfast containing high quality protein source (eggs) would be more effective in reducing hunger and increasing feeling of fullness compared to a breakfast containing a lower quality of protein, but equal energy density. A previous pilot study with the same endpoints yielded borderline significant results; this study has been powered based on that pilot to interrogate our hypotheses.
Read the detailed description
This will be a crossover study with 2 experiments. Subjects will follow a reduced energy weight loss diet of 1,200-1,500 kcal adjusted to each individual's body weight for totally 2 weeks in each experiment. They will come to the clinic from day 1 to day 7 and consume egg breakfast (EB) for 5 days under our supervision. Then on weekends during this period they will continue this breakfast at home based on our advice. The next week they will have cereal breakfast (CB) and the process is similar to that in the first week.
The 1st experiment will test the satiety from egg breakfast (EB) and following energy intake in both lunch and dinner, compared with CB (cereal breakfast). Lunch and dinner will be offered on 2 test days during each week. Anthropometric and body composition measurements, blood pressure, blood draw, satiety questionnaire, as well as energy intake will also be collected in the 2 test days and compared between 2 breakfast groups.
The 2nd one is to test whether EB will help in resisting the intake of foods considered tempting, but detrimental to weight loss efforts, compared with CB. The process is similar to experiment 1 except no blood draw, no dinner offered. Instead, a tempting food after lunch will be offered.
- Conditions
- Obesity
- Being tested
- Egg breakfast (EB), Weight Loss Counseling, Weight Loss Diet, Cereal Breakfast (CB)
- Keywords
- Egg breakfast, Weight loss, Satiety, Insulin, Glucagon-Like Peptide 1, PYY (3-36) peptide, Ghrelin, Glucose, Protein quality
- Medical subject headings
- Obesity, Weight Loss, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg breakfast (EB)Behavioural
Breakfast is considered as high quality protein diet, but has similar weight, energy, and macronutrients as the active comparator. The details are as follows: weight 291 g,energy 400 kcal, energy density 1.37 kcal/g, carbohydrate 42.9%, fat 35.6%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 100, leucine 1.77 g, glycemic load 24, fiber 1.0 g.
Weight Loss CounselingBehavioural
Weight loss counseling will be administered by a Registered Dietitian and will utilize information and materials derived from the Evidence Analysis Library (EAL) of the Academy of Nutrition and Dietetics (AND). Topics will include portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, as well as behavioral strategies including self-monitoring, motivational interviewing, goal setting, and problem solving.
Weight Loss DietBehavioural
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
Cereal Breakfast (CB)Behavioural
Breakfast is considered as low quality protein diet, but has similar weight, energy, and macronutrients as that in experimental group. The details are as follows: weight 293 g, energy 398 kcal, energy density 1.36 kcal/g, carbohydrate 44.8%, fat 35.4%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 42, leucine 0.48 g, glycemic load 30.8, fiber 4.4 g.
| Study group | Role | What they receive |
|---|---|---|
| Egg Breakfast (EB) | Experimental | The EB will receive the following breakfast:
2 scrambled eggs, 120 mL skim milk, 2 slices of Mrs. Bairds® Extra Thin White Bread, 5 g of butter, and 18 g of Smuckers® Strawberry Jam. Receives: Behavioral: Egg breakfast (EB); Behavioral: Weight Loss Counseling; Behavioral: Weight Loss Diet |
| Cereal Breakfast (CB) | Active comparator | The CB will receive the following breakfast:
1.5 cups of Special K® Ready-to-Eat Original Cereal, 200 ml Silk® Original Soymilk, 1 slice of Nature's Own® Double Fiber Wheat Bread, 13 g of butter, and 10 g of Smuckers® Sugar-Free Strawberry Jam. Receives: Behavioral: Weight Loss Counseling; Behavioral: Weight Loss Diet; Behavioral: Cereal Breakfast (CB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of subjective satiety
This will be measured by questionnaire (VAS) and compared the changes between 2 test days (day 7 and day 14) in experiment 1\&2
Measured: Change in scores (arbitrary units AUC) from 30 minutes before breakfast consumption to 240 minutes after the consumption on day 7 and day 14
Change of objective satiety
It is measured by GLP-1. This will be tested in experiment 1 and changes will be compared between 2 test days.
Measured: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14
Change of objective satiety
It is measured by PYY 3-36. This will be tested in experiment 1 and changes will be compared between 2 test days.
Measured: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Change of objective satiety
It is measured by ghrelin. This will be tested in experiment 1 and changes will be compared between 2 test days.
Measured: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Other change of hormone level
It is measured by serum glucose. This will be tested in experiment 1 and changes will be compared between 2 test days.
Measured: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Other change of hormone level
It is measured insulin levels. This will be tested in experiment 1 and changes will be compared between 2 test days.
Measured: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Energy intake (kcal) during ad libitum lunch
Energy intake will be compared between 2 test days in experiment 1
Measured: Test day 7 and day 14
Energy intake (kcal) during ad libitum dinner
Energy intake will be compared between 2 test days in experiment 1
Measured: Test day 7 and day 14
Energy intake (kcal) during ad libitum lunch
Chocolate brownies will be added to the test lunch. Energy intake will be compared between 2 test days in experiment 2
Measured: Test day 7 and day 14
Secondary outcomes (6)
Change in body weight (kg)
Body weight change from baseline to day 7, and change from day 7 to day 14 will be compared
Measured: Day 0, day 7 and day 14
Change in waist and hip circumference (cm)
Waist and hip circumference change from baseline to day 7, and change from day 7 to day 14 will be compared
Measured: Day 0, day 7 and day 14
Change in blood pressure (mm Hg)
BP change from baseline to day 7, and change from day 7 to day 14 will be compared
Measured: Day 0, day 7 and day 14
Change in fat mass and lean body mass percentage
Body fat change from baseline to day 7, and change from day 7 to day 14 will be compared
Measured: Day 0, day 7 and day 14
Self report bias in weight, height and body fat percentage
Difference of measurements between self report survey and objective results
Measured: Day 0
Self report of desire to lose weight and ideal weight
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start20 Aug 2017
- Primary completion17 May 2019
- Study completion17 May 2019
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 ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within subjects comparison will be performed. Subjects will be assigned to either group A (EB first then CB) or group B (CB first then EB) for a week and then reverse to the opposite breakfast the next week
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Sponsor
- Investigators
- Nikhil Dhurandhar, Principal investigator, Chair of the Nutritional Sciences Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085511
- Sponsor's protocol ID
- TTU IRB2016-1137
- Acronym
- Egg_breakfast
- Status last verified
- May 2019
- First submitted
- 15 Mar 2017
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayham BE, Greenway FL, Johnson WD, Dhurandhar NV. A randomized trial to manipulate the quality instead of quantity of dietary proteins to influence the markers of satiety. J Diabetes Complications. 2014 Jul-Aug;28(4):547-52. doi: 10.1016/j.jdiacomp.2014.02.002. Epub 2014 Feb 13.
PubMed 24703415Vander Wal JS, Gupta A, Khosla P, Dhurandhar NV. Egg breakfast enhances weight loss. Int J Obes (Lond). 2008 Oct;32(10):1545-51. doi: 10.1038/ijo.2008.130. Epub 2008 Aug 5.
PubMed 18679412Vander Wal JS, Marth JM, Khosla P, Jen KL, Dhurandhar NV. Short-term effect of eggs on satiety in overweight and obese subjects. J Am Coll Nutr. 2005 Dec;24(6):510-5. doi: 10.1080/07315724.2005.10719497.
PubMed 16373948
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Higher Protein Quality Reduce Energy Intake When Following a Weight Loss Diet Plan? -- Nonpilot, Powered Crossover
- ClinicalTrials.gov ID
- NCT03085511
- Acronym / sponsor ID
- Egg_breakfast / TTU IRB2016-1137
- Conditions
- Obesity
- Keywords
- Egg breakfast, Weight loss, Satiety, Insulin, Glucagon-Like Peptide 1, PYY (3-36) peptide, Ghrelin, Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 21 Mar 2017 (actual)
- 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.
The purpose of this study is to determine if, in presence of a reduced calorie diet, a breakfast containing high quality protein source (eggs) would be more effective in reducing hunger and increasing feeling of fullness compared to a breakfast containing a lower quality of protein, but equal energy density. A previous pilot study with the same endpoints yielded borderline significant results; this study has been powered based on that pilot to interrogate our hypotheses.
Detailed description
This will be a crossover study with 2 experiments. Subjects will follow a reduced energy weight loss diet of 1,200-1,500 kcal adjusted to each individual's body weight for totally 2 weeks in each experiment. They will come to the clinic from day 1 to day 7 and consume egg breakfast (EB) for 5 days under our supervision. Then on weekends during this period they will continue this breakfast at home based on our advice. The next week they will have cereal breakfast (CB) and the process is similar to that in the first week.
The 1st experiment will test the satiety from egg breakfast (EB) and following energy intake in both lunch and dinner, compared with CB (cereal breakfast). Lunch and dinner will be offered on 2 test days during each week. Anthropometric and body composition measurements, blood pressure, blood draw, satiety questionnaire, as well as energy intake will also be collected in the 2 test days and compared between 2 breakfast groups.
The 2nd one is to test whether EB will help in resisting the intake of foods considered tempting, but detrimental to weight loss efforts, compared with CB. The process is similar to experiment 1 except no blood draw, no dinner offered. Instead, a tempting food after lunch will be offered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within subjects comparison will be performed. Subjects will be assigned to either group A (EB first then CB) or group B (CB first then EB) for a week and then reverse to the opposite breakfast the next week
| Arm | Type | Receives |
|---|---|---|
| Egg Breakfast (EB) | Experimental | Behavioral: Egg breakfast (EB), Behavioral: Weight Loss Counseling, Behavioral: Weight Loss DietThe EB will receive the following breakfast: 2 scrambled eggs, 120 mL skim milk, 2 slices of Mrs. Bairds® Extra Thin White Bread, 5 g of butter, and 18 g of Smuckers® Strawberry Jam. |
| Cereal Breakfast (CB) | Active comparator | Behavioral: Weight Loss Counseling, Behavioral: Weight Loss Diet, Behavioral: Cereal Breakfast (CB)The CB will receive the following breakfast: 1.5 cups of Special K® Ready-to-Eat Original Cereal, 200 ml Silk® Original Soymilk, 1 slice of Nature's Own® Double Fiber Wheat Bread, 13 g of butter, and 10 g of Smuckers® Sugar-Free Strawberry Jam. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Overweight and class I-II obese (BMI 25.0-39.9)
- Sedentary (<3 hours/week of moderate intensity physical activity)
- Otherwise healthy
Key exclusion criteria (14 listed)
- ≥5% body weight loss or gain in the three months preceding the study
- Post-menopausal (has not had period for 12 months)
- Plans to begin an exercise program or change current exercise routines between initiation of study and final study
- Anyone following a medical diet prescription
- Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type
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 |
|---|---|---|
| Egg breakfast (EB)Breakfast is considered as high quality protein diet, but has similar weight, energy, and macronutrients as the active comparator. The details are as follows: weight 291 g,energy 400 kcal, energy density 1.37 kcal/g, carbohydrate 42.9%, fat 35.6%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 100, leucine 1.77 g, glycemic load 24, fiber 1.0 g. | Behavioural | Egg Breakfast (EB) |
| Weight Loss CounselingWeight loss counseling will be administered by a Registered Dietitian and will utilize information and materials derived from the Evidence Analysis Library (EAL) of the Academy of Nutrition and Dietetics (AND). Topics will include portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, as well as behavioral strategies including self-monitoring, motivational interviewing, goal setting, and problem solving. | Behavioural | Cereal Breakfast (CB), Egg Breakfast (EB) |
| Weight Loss DietParticipants will have a 1200-1500kcals diet based on each individual's body weight during the study. | Behavioural | Cereal Breakfast (CB), Egg Breakfast (EB) |
| Cereal Breakfast (CB)Breakfast is considered as low quality protein diet, but has similar weight, energy, and macronutrients as that in experimental group. The details are as follows: weight 293 g, energy 398 kcal, energy density 1.36 kcal/g, carbohydrate 44.8%, fat 35.4%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 42, leucine 0.48 g, glycemic load 30.8, fiber 4.4 g. | Behavioural | Cereal Breakfast (CB) |
Primary outcome
Change of subjective satiety
Time frame: Change in scores (arbitrary units AUC) from 30 minutes before breakfast consumption to 240 minutes after the consumption on day 7 and day 14
This will be measured by questionnaire (VAS) and compared the changes between 2 test days (day 7 and day 14) in experiment 1\&2
Change of objective satiety
Time frame: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14
It is measured by GLP-1. This will be tested in experiment 1 and changes will be compared between 2 test days.
Change of objective satiety
Time frame: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
It is measured by PYY 3-36. This will be tested in experiment 1 and changes will be compared between 2 test days.
Change of objective satiety
Time frame: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
It is measured by ghrelin. This will be tested in experiment 1 and changes will be compared between 2 test days.
Other change of hormone level
Time frame: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
It is measured by serum glucose. This will be tested in experiment 1 and changes will be compared between 2 test days.
Other change of hormone level
Time frame: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
It is measured insulin levels. This will be tested in experiment 1 and changes will be compared between 2 test days.
Energy intake (kcal) during ad libitum lunch
Time frame: Test day 7 and day 14
Energy intake will be compared between 2 test days in experiment 1
Energy intake (kcal) during ad libitum dinner
Time frame: Test day 7 and day 14
Energy intake will be compared between 2 test days in experiment 1
Energy intake (kcal) during ad libitum lunch
Time frame: Test day 7 and day 14
Chocolate brownies will be added to the test lunch. Energy intake will be compared between 2 test days in experiment 2
6 secondary outcomes
Change in body weight (kg)
Time frame: Day 0, day 7 and day 14
Change in waist and hip circumference (cm)
Time frame: Day 0, day 7 and day 14
Change in blood pressure (mm Hg)
Time frame: Day 0, day 7 and day 14
Change in fat mass and lean body mass percentage
Time frame: Day 0, day 7 and day 14
Self report bias in weight, height and body fat percentage
Time frame: Day 0
Self report of desire to lose weight and ideal weight
Time frame: Day 0
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 30 May 2019.
- Background: PubMed 24703415Bayham BE, Greenway FL, Johnson WD, Dhurandhar NV. A randomized trial to manipulate the quality instead of quantity of dietary proteins to influence the markers of satiety. J Diabetes Complications. 2014 Jul-Aug;28(4):547-52. doi: 10.1016/j.jdiacomp.2014.02.002. Epub 2014 Feb 13.
- Background: PubMed 18679412Vander Wal JS, Gupta A, Khosla P, Dhurandhar NV. Egg breakfast enhances weight loss. Int J Obes (Lond). 2008 Oct;32(10):1545-51. doi: 10.1038/ijo.2008.130. Epub 2008 Aug 5.
- Background: PubMed 16373948Vander Wal JS, Marth JM, Khosla P, Jen KL, Dhurandhar NV. Short-term effect of eggs on satiety in overweight and obese subjects. J Am Coll Nutr. 2005 Dec;24(6):510-5. doi: 10.1080/07315724.2005.10719497.
- Individual participant dataSharing planned: No
Related trials for Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Recruiting
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
RecruitingPhase 1
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Valid MeSH Conditiongs
Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Skin Laxity, Localized Adiposity
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.
Nikhil Dhurandhar principal investigator
Chair of the Nutritional Sciences Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg breakfast (EB), Weight Loss Counseling and Weight Loss Diet in people with Obesity, run by Texas Tech University at 1 site in United States.
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 3 inclusion and 14 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 30 May 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 United States. 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?
Change of subjective satiety (time frame: Change in scores (arbitrary units AUC) from 30 minutes before breakfast consumption to 240 minutes after the consumption on day 7 and day 14). The study lists 9 primary outcomes in all. 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 NCT03085511, 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 30 May 2019.