Protein Eating Patterns and Weight Loss

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Daily Protein Intake Patterns During Weight Loss on Dietary Adherence and Body Composition in Women

Conditions
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Obesity

Intervention / Treatment
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* Other: Even protein
* Other: Skewed protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Even protein intake<br>Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal. | Other: Even protein<br>* Intake of even protein 5 day rotating menu<br>|
| Experimental: Skewed protein intake<br>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. | Other: Skewed protein<br>* Intake of skewed protein 5 day rotating menu<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | Determine the effects of two patterns of daily protein intake on changes in fat mass and fat-free mass during weight loss. | 8 and 16 weeks | 
| Diet Adherence | 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. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers to weight control | Nominal Group Technique results providing an exhaustive list of barriers to weight control in overweight and obese women | 1 hour | 
| Change in skeletal muscle protein breakdown | The effect of consuming two patterns of daily protein intake on 3-Methylhistidine degradation, a biochemcial marker of skeletal muscle protein breakdown | 8 and 16 weeks | 
| Circulating carotenoid levels | The effect of consuming two patterns of protein intake during weight loss on circulating carotenoid levels. | 8 and 16 weeks | 
| Relative reinforcing value (RRV) of food | The effect of consuming two patterns of daily protein intake during weight loss on the RRV of energy-dense snack food | 8 and 16 weeks | 
| Change in bone turnover | 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 | 8 and 16 weeks | 
| Plasma lipids | The effect of consuming two patterns of daily protein intake during weight loss on lipid and triglyceride molecular speciation. | 8 and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein, Weight Loss