Protein Eating Patterns and Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202069
• Other study ID #: GFHNRC510
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: April 14, 2023

Study information

• Verified date: October 2023
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• Even protein
Intake of even protein 5 day rotating menu
• Skewed protein
Intake of skewed protein 5 day rotating menu

Locations

Country	Name	City	State
United States	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota

Sponsors (2)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center	North Dakota Beef Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Barriers to weight control	Nominal Group Technique results providing an exhaustive list of barriers to weight control in overweight and obese women	1 hour
Secondary	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
Secondary	Circulating carotenoid levels	The effect of consuming two patterns of protein intake during weight loss on circulating carotenoid levels.	8 and 16 weeks
Secondary	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
Secondary	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
Secondary	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

External Links

•   Grand Forks Human Nutrition Research Center Current Nutrition Studies