High Quality Protein for Assisting With Weight Loss

NCT03085511 | Completed

• 1 other identifier: TTU IRB2016-1137
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity

Keywords

Egg breakfast; Weight loss; Satiety; Insulin; Glucagon-Like Peptide 1; PYY (3-36) peptide; Ghrelin; Glucose; Protein quality

Outcome Measures

Primary Outcomes (9)

• 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

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  Test day 7 and day 14

Secondary Outcomes (6)

• Change in body weight (kg)

  Day 0, day 7 and day 14

• Change in waist and hip circumference (cm)

  Day 0, day 7 and day 14

• Change in blood pressure (mm Hg)

  Day 0, day 7 and day 14

• Change in fat mass and lean body mass percentage

  Day 0, day 7 and day 14

• Self report bias in weight, height and body fat percentage

  Day 0

Study Arms (2)

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.

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.

Behavioral: Weight Loss Counseling; Behavioral: Weight Loss Diet; Behavioral: Cereal Breakfast (CB)

Interventions

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.

Egg Breakfast (EB)

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.

Cereal Breakfast (CB); Egg Breakfast (EB)

Weight Loss Diet BEHAVIORAL

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

Cereal Breakfast (CB); Egg Breakfast (EB)

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.

Cereal Breakfast (CB)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• ≥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

Sponsors & Collaborators

• Texas Tech University: lead
• American Egg Board: collaborator

Study Sites (1)

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, 79409, United States

Location

Related Publications (3)

• 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.

  PMID: 24703415 BACKGROUND

• 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.

  PMID: 18679412 BACKGROUND

• 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.

  PMID: 16373948 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss; Insulin Resistance

Interventions

Diet, Reducing

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nikhil Dhurandhar

  Chair of the Nutritional Sciences Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 21, 2017
• Study Start: August 20, 2017
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)