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Completed

NCT Number: NCT03085511

High Quality Protein for Assisting With Weight Loss

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.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, 79409, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overweight and class I-II obese (BMI 25.0-39.9)
  • Sedentary (<3 hours/week of moderate intensity physical activity)
  • Otherwise healthy

Exclusion criteria

  • ≥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
  • 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

Treatment and study plan

Egg breakfast (EB)

Behavioral

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 Counseling

Behavioral

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 diet

Behavioral

Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.

Cereal Breakfast (CB)

Behavioral

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.

Primary outcomes

  1. 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

  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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

Secondary outcomes

  1. Change in body weight (kg)

    Time frame: Day 0, day 7 and day 14

    Body weight change from baseline to day 7, and change from day 7 to day 14 will be compared

  2. Change in waist and hip circumference (cm)

    Time frame: Day 0, day 7 and day 14

    Waist and hip circumference change from baseline to day 7, and change from day 7 to day 14 will be compared

  3. Change in blood pressure (mm Hg)

    Time frame: Day 0, day 7 and day 14

    BP change from baseline to day 7, and change from day 7 to day 14 will be compared

  4. Change in fat mass and lean body mass percentage

    Time frame: Day 0, day 7 and day 14

    Body fat change from baseline to day 7, and change from day 7 to day 14 will be compared

  5. Self report bias in weight, height and body fat percentage

    Time frame: Day 0

    Difference of measurements between self report survey and objective results

  6. Self report of desire to lose weight and ideal weight

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Collaborators

  • American Egg Board

Registry information

Official study title

Does Higher Protein Quality Reduce Energy Intake When Following a Weight Loss Diet Plan? -- Nonpilot, Powered Crossover

Acronym: Egg_breakfast

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2017
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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