ObesityNCT02497859
Breakfast Intake and Satiety Hormones
A study testing Egg Breakfast (EB), Cereal Breakfast (CB) and Weight Loss Counseling in people with Obesity, run by Texas Tech University at 1 site in United States.
Trial summary
The experiments in this study will assess if while following a reduced energy diet, eating a breakfast with higher protein quality will enhance weight loss compared to another breakfast with lower protein quality, but matched for energy density and macronutrient composition. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Egg Breakfast (EB), Cereal Breakfast (CB) and Weight Loss Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to May 2016
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Calculated BMI of 25.0-39.9 kg/m2
- 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
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 Breakfast Reduce Energy Intake When Following a Weight Loss Diet Plan?
The experiments in this study will assess if while following a reduced energy diet, eating a breakfast with higher protein quality will enhance weight loss compared to another breakfast with lower protein quality, but matched for energy density and macronutrient composition.
Read the detailed description
There will be 2 experiments in this pilot study. Both will be randomized crossover study designs with subjects beginning on either an egg breakfast of higher protein quality or cereal breakfast of lower protein quality, and reversing to receive the breakfast not previously ingested. The subjects will consume breakfasts under supervision at our clinic on all days of the study, except for weekends. Subjects will be advised to continue eating their breakfast at home on weekends. All subjects will receive weight loss counseling and follow a weight loss diet for 2 weeks. Experiment 1 will test the hypothesis that when on a reduced calorie diet, intake of an egg breakfast compared to cereal breakfast increases satiety, reduces lunch time energy consumption and reduces dinner time energy consumption in clinical and free living condition. Insulin, glucagon-like peptide-1, peptide YY 3-36, ghrelin, plasma glucose, baseline and post intervention anthropomorphic measurements, and hunger questionnaires completed during the consumption of both breakfasts and subsequent meals will be compared. Experiment 2 will compare the effects of the two breakfasts on intake of foods considered tempting or highly palatable, and assessment of energy intake pre/post test lunch followed by offering brownies. It is hypothesized that consumption of an egg breakfast compared to cereal breakfast, will help in reducing intake of foods considered tempting.
- Conditions
- Obesity
- Being tested
- Egg Breakfast (EB), Cereal Breakfast (CB), Weight Loss Counseling, Weight Loss Diet
- Keywords
- Weight Reduction, Weight Loss Diet, Satiety Response, Insulin, Glucagon-Like Peptide 1, PYY (3-36) peptide, Ghrelin, Glucose, Eggs, Protein, Energy Intake, Breakfast
- 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
The EB will receive a breakfast of higher quality protein, but similar in macronutrient and energy density than the active comparator. The EB will have the following energy density, macronutrient composition, and protein score: weight 291 g,energy 400 kcal, energy density 1.37 kcal/g, carbohydrate 42.9%, fat 35.5%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 100, leucine 1.77 g, glycemic load 24, fiber 1.0 g.
Cereal Breakfast (CB)Behavioural
The CB will receive a breakfast of lower quality protein, but similar in macronutrient and energy density than the experimental treatment. The CB will have the following energy density, macronutrient composition, and protein score: weight 293 g, energy 398 kcal, energy density 1.3 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.
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 including portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, will be discussed. Self-monitoring, motivational interviewing, goal setting, and problem solving will be the behavioral strategies used during counseling.
Weight Loss DietBehavioural
Energy intake for study duration will be prescribed at 1,200-1,500 kcals adjusted for each individual's body weight.
| 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: Cereal Breakfast (CB); Behavioral: Weight Loss Counseling; Behavioral: Weight Loss Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subjective hunger questionnaire (Visual Analog Scale)
Measured: Change in scores (arbitrary units AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
Change in serum satiety and hunger hormones
Concentrations of ghrelin, GLP1, PYY 3-36, insulin, and serum glucose will be determined. This is only for experiment 1.
Measured: Change (AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
Energy intake (kcal) during ad libitum lunch
This is for experiment 1.
Measured: Test day 7 (30 minutes for buffet).
Energy intake (kcal) during ad libitum lunch
This is for experiment 1.
Measured: Test day 14 (30 minutes for buffet).
Energy intake (kcal) during ad libitum dinner
This is for experiment 1.
Measured: Test day 7 (30 minutes for buffet).
Energy intake (kcal) during ad libitum dinner
This is for experiment 1.
Measured: Test day 14 (30 minutes for buffet).
Energy intake (kcal) during ad libitum lunch
This is for experiment 2. Chocolate brownies will be added to the test lunch.
Measured: Test day 7 (30 minutes for buffet).
Energy intake (kcal) during ad libitum lunch
This is for experiment 2. Chocolate brownies will be added to the test lunch.
Measured: Test day 14 (30 minutes for buffet).
Secondary outcomes (7)
Change in body weight in kilograms
Measured: Change in kilograms from baseline to test day 7.
Change in body weight in kilograms
Measured: Change in kilograms from test day 7 to test day 14.
Change in waist and hip circumference in centimeters
Measured: Change in centimeters from baseline to test day 7.
Change in waist and hip circumference in centimeters
Measured: Change in centimeters from test day 7 to test day 14.
Change in blood pressure (mm Hg)
Measured: Change in mm Hg from baseline to test day 7.
Change in blood pressure (mm Hg)
Measured: Change in mm Hg from test day 7 to test day 14.
Change in fat mass and lean body mass percentage
Measured: Change in percentage from test day 0 to test day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionMay 2016
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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Nikhil Dhurandhar, Texas Tech University
- Investigators
- Nikhil Dhurandhar, PhD, Principal investigator, Chair of the Nutritional Sciences Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497859
- Sponsor's protocol ID
- 505159
- Status last verified
- Sep 2016
- First submitted
- 8 Jul 2015
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- 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 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Higher Protein Quality Breakfast Reduce Energy Intake When Following a Weight Loss Diet Plan?
- ClinicalTrials.gov ID
- NCT02497859
- Acronym / sponsor ID
- 505159
- Conditions
- Obesity
- Keywords
- Weight Reduction, Weight Loss Diet, Satiety Response, Insulin, Glucagon-Like Peptide 1, PYY (3-36) peptide, Ghrelin, Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- Sep 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Jul 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.
The experiments in this study will assess if while following a reduced energy diet, eating a breakfast with higher protein quality will enhance weight loss compared to another breakfast with lower protein quality, but matched for energy density and macronutrient composition.
Detailed description
There will be 2 experiments in this pilot study. Both will be randomized crossover study designs with subjects beginning on either an egg breakfast of higher protein quality or cereal breakfast of lower protein quality, and reversing to receive the breakfast not previously ingested. The subjects will consume breakfasts under supervision at our clinic on all days of the study, except for weekends. Subjects will be advised to continue eating their breakfast at home on weekends. All subjects will receive weight loss counseling and follow a weight loss diet for 2 weeks. Experiment 1 will test the hypothesis that when on a reduced calorie diet, intake of an egg breakfast compared to cereal breakfast increases satiety, reduces lunch time energy consumption and reduces dinner time energy consumption in clinical and free living condition. Insulin, glucagon-like peptide-1, peptide YY 3-36, ghrelin, plasma glucose, baseline and post intervention anthropomorphic measurements, and hunger questionnaires completed during the consumption of both breakfasts and subsequent meals will be compared. Experiment 2 will compare the effects of the two breakfasts on intake of foods considered tempting or highly palatable, and assessment of energy intake pre/post test lunch followed by offering brownies. It is hypothesized that consumption of an egg breakfast compared to cereal breakfast, will help in reducing intake of foods considered tempting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| 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: Cereal Breakfast (CB), Behavioral: Weight Loss Counseling, Behavioral: Weight Loss DietThe 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
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Calculated BMI of 25.0-39.9 kg/m2
- 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)The EB will receive a breakfast of higher quality protein, but similar in macronutrient and energy density than the active comparator. The EB will have the following energy density, macronutrient composition, and protein score: weight 291 g,energy 400 kcal, energy density 1.37 kcal/g, carbohydrate 42.9%, fat 35.5%, 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) |
| Cereal Breakfast (CB)The CB will receive a breakfast of lower quality protein, but similar in macronutrient and energy density than the experimental treatment. The CB will have the following energy density, macronutrient composition, and protein score: weight 293 g, energy 398 kcal, energy density 1.3 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) |
| 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 including portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, will be discussed. Self-monitoring, motivational interviewing, goal setting, and problem solving will be the behavioral strategies used during counseling. | Behavioural | Cereal Breakfast (CB), Egg Breakfast (EB) |
| Weight Loss DietEnergy intake for study duration will be prescribed at 1,200-1,500 kcals adjusted for each individual's body weight. | Behavioural | Cereal Breakfast (CB), Egg Breakfast (EB) |
Primary outcome
Change in subjective hunger questionnaire (Visual Analog Scale)
Time frame: Change in scores (arbitrary units AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
Change in serum satiety and hunger hormones
Time frame: Change (AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
Concentrations of ghrelin, GLP1, PYY 3-36, insulin, and serum glucose will be determined. This is only for experiment 1.
Energy intake (kcal) during ad libitum lunch
Time frame: Test day 7 (30 minutes for buffet).
This is for experiment 1.
Energy intake (kcal) during ad libitum lunch
Time frame: Test day 14 (30 minutes for buffet).
This is for experiment 1.
Energy intake (kcal) during ad libitum dinner
Time frame: Test day 7 (30 minutes for buffet).
This is for experiment 1.
Energy intake (kcal) during ad libitum dinner
Time frame: Test day 14 (30 minutes for buffet).
This is for experiment 1.
Energy intake (kcal) during ad libitum lunch
Time frame: Test day 7 (30 minutes for buffet).
This is for experiment 2. Chocolate brownies will be added to the test lunch.
Energy intake (kcal) during ad libitum lunch
Time frame: Test day 14 (30 minutes for buffet).
This is for experiment 2. Chocolate brownies will be added to the test lunch.
7 secondary outcomes
Change in body weight in kilograms
Time frame: Change in kilograms from baseline to test day 7.
Change in body weight in kilograms
Time frame: Change in kilograms from test day 7 to test day 14.
Change in waist and hip circumference in centimeters
Time frame: Change in centimeters from baseline to test day 7.
Change in waist and hip circumference in centimeters
Time frame: Change in centimeters from test day 7 to test day 14.
Change in blood pressure (mm Hg)
Time frame: Change in mm Hg from baseline to test day 7.
Change in blood pressure (mm Hg)
Time frame: Change in mm Hg from test day 7 to test day 14.
Change in fat mass and lean body mass percentage
Time frame: Change in percentage from test day 0 to test day 14.
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 16 Sep 2016.
- 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
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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.
Nikhil Dhurandhar, PhD 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), Cereal Breakfast (CB) and Weight Loss Counseling 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 16 Sep 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 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 in subjective hunger questionnaire (Visual Analog Scale) (time frame: Change in scores (arbitrary units AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.). The study lists 8 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 NCT02497859, 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 16 Sep 2016.