The Role of Protein in Regulating Ad Libitum Energy Intake in Humans

NCT02613065 | Completed

• 1 other identifier: F141121006
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to determine if protein is less likely to create positive energy balance when added to the diet compared to carbohydrate. To do this, the investigators will take detailed measurements of participant's baseline metabolic rate to understand their energy requirements. Then, the investigators will feed participants all their meals for two weeks, Monday-Friday, and measure their food intake. During one of the week-long feeding periods, participants will consume a shake made of egg protein that is \~20% of their energy requirements. During the other week, participants will consume a shake made of carbohydrate that is \~20% of their energy requirements. Participants will drink the assigned shake at the beginning of each of their daily three meals, and then they will be offered a 'regular' meal of unlimited quantity. Participants will not know that the investigators are measuring the food consumed after drinking the shake. Participants will drink the protein shake for the first week and carb-based shake for the second week, and vice versa-- depending on the randomization order. To account for energy expenditure, participants will wear an activity monitor, an accelerometer. Energy balance, measured as participant energy intake minus energy expenditure, will be our main outcome for each treatment. However, because participants may change their behavior if made aware of the true research question, the investigators will tell participants that the purpose of the study is to see how low fiber and high fiber shakes affect mood. The hypothesis is that during the week when participants consume the protein shake, they will remain in energy balance, but during the week of carbohydrate shake consumption, participants will have positive energy balance.

Conditions

Energy Balance

Keywords

Ad libitum; Energy balance; Protein

Outcome Measures

Primary Outcomes (1)

• Energy Balance measured as participant energy intake (food weight before and after meals) minus energy expenditure (accelerometer)

  Feeding periods are separated by two weeks.

  10 days

Study Arms (2)

Eggwhite protein shake

EXPERIMENTAL

Participants drink a NOW Foods protein shake (\~20% daily energy requirements) at the beginning of each of the three daily meals. Kcals/meal are dependent upon participant's baseline Resting Metabolic Rate value.

Dietary Supplement: Consumption of NOW Foods eggwhite protein shake

Maltodextrin carbohydrate shake

ACTIVE COMPARATOR

Participants drink a NOW Foods carbohydrate shake (\~20% daily energy requirements) at the beginning of each of the three daily meals. Kcals/meal are dependent upon participant's baseline Resting Metabolic Rate value.

Dietary Supplement: Consumption of NOW Foods maltodextrin shake

Interventions

Consumption of NOW Foods eggwhite protein shake DIETARY_SUPPLEMENT

Consumption of NOW Foods egg white protein shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs.

Eggwhite protein shake

Consumption of NOW Foods maltodextrin shake DIETARY_SUPPLEMENT

Consumption of NOW Foods maltodextrin shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs.

Maltodextrin carbohydrate shake

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI ≥20, and ≤30 kg/m2
• Moderately active or sedentary (Physical Activity Level \<2.0)

You may not qualify if:

• Any food allergy.
• Religious affiliations that include specific food guidelines.
• Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months.
• Weight loss or gain of \>5% of body weight in the past 6 months for any reason except post-partum weight loss.
• Currently taking medication that suppresses or stimulates appetite or that affects body weight, including oral anti-diabetic medications.
• History of prior surgical procedure for weight control.
• Anyone currently taking statins.
• Claustrophobia
• Current smoker or quit smoking less than 6 months prior.
• Any major disease, including:
• Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
• Active or chronic infections, including self-reported HIV positivity and active tuberculosis. -Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class \>2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months.
• Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
• Active renal disease.
• Lung disease: chronic obstructive airway disease requiring use of oxygen.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Egg Nutrition Center: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Gibson MJ, Dawson JA, Wijayatunga NN, Ironuma B, Chatindiara I, Ovalle F, Allison DB, Dhurandhar EJ. A randomized cross-over trial to determine the effect of a protein vs. carbohydrate preload on energy balance in ad libitum settings. Nutr J. 2019 Nov 9;18(1):69. doi: 10.1186/s12937-019-0497-4.

  PMID: 31706311 DERIVED

Study Officials

• David B Allison, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: School of Public Health Associate Dean for Research

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 24, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 22, 2016

Record last verified: 2016-08

Locations

US (1)