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Protein Eating Patterns and Weight Loss

U

USDA Grand Forks Human Nutrition Research Center

Status

Completed

Conditions

Obesity

Treatments

Other: Even protein
Other: Skewed protein

Study type

Interventional

Funder types

Other U.S. Federal agency
Other

Identifiers

NCT03202069
GFHNRC510

Details and patient eligibility

About

The purpose of this study is to determine the effects of daily protein intake patterns on body composition and eating behaviors during weight loss.

Full description

The reinforcing value of food varies greatly among individuals, but is strongest for those who are overweight or obese. Reducing energy intake, which is necessary for overweight and obese individuals to achieve a healthier body weight, increases the reinforcing value of food - especially for energy-dense snack foods. Food is a powerful reinforcer and is associated with energy intake; making it a primary contributing factor to an individual's weight loss struggle. Developing a way to decrease or limit the increase in food reinforcement during energy deficits would have important clinical impact. High-protein diets are known to be efficacious for weight loss and recently have been shown to decrease stimulation of the reward areas of the brain that stimulate reward-driven eating behavior. Nonetheless, sustaining a high-protein diet can be difficult, especially for women. Consuming a modest amount of protein at each meal may be better tolerated. However, we do not know whether this pattern of protein intake can assist women in staying "on track" with weight loss goals. This study will help begin to elucidate the connections between the daily pattern of protein intake on diet adherence, alterations in food reinforcement, and favorable body composition changes during weight loss.

Enrollment

45 patients

Sex

Female

Ages

20 to 44 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • BMI 28-45 kg/m2

Exclusion criteria

  • unable or unwilling to consume animal products
  • unable or unwilling to attend treatment group meetings
  • had more than a 10% change in body weight in the 2 months prior to study start date
  • consuming a specialized diet
  • have a history of and eating or gastrointestinal disorder
  • currently or planning on becoming pregnant during the study timeline
  • lactating
  • have an uncontrolled metabolic illness/disease (fasting glucose >125 mg/dL)
  • have uncontrolled hypertension (>160/99 mm Hg)
  • have cancer or in short-term remission (less than 3 years)
  • have an infectious disease
  • suffer from alcohol or drug abuse
  • use tobacco and/or e-cigarette products on a regular basis
  • taking medications known to affect energy expenditure and appetite

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups

Even protein intake
Experimental group
Description:
Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.
Treatment:
Other: Even protein
Skewed protein intake
Experimental group
Description:
Menu to provide 90 g of protein per day in a skewed distribution of 10 g at breakfast, 15 g at lunch and 65 g at dinner.
Treatment:
Other: Skewed protein

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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