Breakfast Intake and Satiety Hormones

NCT ID: NCT02497859

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-05-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Egg Breakfast (EB)

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.

Group Type: EXPERIMENTAL

Egg Breakfast (EB)

Intervention Type: BEHAVIORAL

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.

Weight Loss Counseling

Intervention Type: 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 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 Diet

Intervention Type: BEHAVIORAL

Energy intake for study duration will be prescribed at 1,200-1,500 kcals adjusted for each individual's body weight.

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.

Group Type: ACTIVE_COMPARATOR

Cereal Breakfast (CB)

Intervention Type: BEHAVIORAL

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 Counseling

Intervention Type: 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 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 Diet

Intervention Type: BEHAVIORAL

Energy intake for study duration will be prescribed at 1,200-1,500 kcals adjusted for each individual's body weight.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Weight Loss Counseling

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.

Intervention Type: BEHAVIORAL

Weight Loss Diet

Energy intake for study duration will be prescribed at 1,200-1,500 kcals adjusted for each individual's body weight.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Calculated BMI of 25.0-39.9 kg/m2
• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American Egg Board

OTHER

Sponsor Role: collaborator

Texas Tech University

OTHER

Sponsor Role: lead

Responsible Party

Nikhil Dhurandhar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikhil Dhurandhar, PhD

Role: PRINCIPAL_INVESTIGATOR

Chair of the Nutritional Sciences Department

Locations

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24703415 (View on PubMed)

Vander 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.

Reference Type: BACKGROUND

PMID: 18679412 (View on PubMed)

Vander 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.

Reference Type: BACKGROUND

PMID: 16373948 (View on PubMed)

Other Identifiers

505159

Identifier Type: -

Identifier Source: org_study_id