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Protein Eating Patterns and Weight Loss

Not Applicable
Completed
Conditions
Obesity
Interventions
Other: Even protein
Other: Skewed protein
Registration Number
NCT03202069
Lead Sponsor
USDA Grand Forks Human Nutrition Research Center
Brief Summary

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

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
45
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Even protein intakeEven proteinMenu to provide 90 g of protein per day in an even distribution of 30 g at each meal.
Skewed protein intakeSkewed proteinMenu 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.
Primary Outcome Measures
NameTimeMethod
Body Composition8 and 16 weeks

Determine the effects of two patterns of daily protein intake on changes in fat mass and fat-free mass during weight loss.

Diet Adherence16 weeks

Determine the effects of two patterns of daily protein intake on weight loss diet adherence and putative mediators (satisfaction, satiety, hunger, and reinforcing value of energy dense foods) of adherence.

Secondary Outcome Measures
NameTimeMethod
Change in bone turnover8 and 16 weeks

The effect of consuming two patterns of daily protein intake during weight loss on osteocalcin, alkaline phosphatase, acid phosphatase, and collagen cross-link molecules -- biochemical markers of bone formation and resorption

Barriers to weight control1 hour

Nominal Group Technique results providing an exhaustive list of barriers to weight control in overweight and obese women

Change in skeletal muscle protein breakdown8 and 16 weeks

The effect of consuming two patterns of daily protein intake on 3-Methylhistidine degradation, a biochemcial marker of skeletal muscle protein breakdown

Circulating carotenoid levels8 and 16 weeks

The effect of consuming two patterns of protein intake during weight loss on circulating carotenoid levels.

Relative reinforcing value (RRV) of food8 and 16 weeks

The effect of consuming two patterns of daily protein intake during weight loss on the RRV of energy-dense snack food

Plasma lipids8 and 16 weeks

The effect of consuming two patterns of daily protein intake during weight loss on lipid and triglyceride molecular speciation.

Trial Locations

Locations (1)

USDA Grand Forks Human Nutrition Research Center

🇺🇸

Grand Forks, North Dakota, United States

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