NCT03202069

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2023

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

5.5 years

First QC Date

June 26, 2017

Last Update Submit

April 11, 2025

Conditions

Obesity

Keywords

ProteinWeight Loss

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Barriers to weight control

    1 hour

  • Change in skeletal muscle protein breakdown

    8 and 16 weeks

  • Circulating carotenoid levels

    8 and 16 weeks

  • Relative reinforcing value (RRV) of food

    8 and 16 weeks

  • Change in bone turnover

    8 and 16 weeks

  • +1 more secondary outcomes

Study Arms (2)

Even protein intake

EXPERIMENTAL

Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.

Other: Even protein

Skewed protein intake

EXPERIMENTAL

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

Interventions

Even proteinOTHER

Intake of even protein 5 day rotating menu

Even protein intake
Skewed proteinOTHER

Intake of skewed protein 5 day rotating menu

Skewed protein intake

Eligibility Criteria

Age20 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 28-45 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Publications (1)

  • De Leon A, Roemmich JN, Casperson SL. Daily Dietary Protein Distribution Does Not Influence Changes in Body Composition During Weight Loss in Women of Reproductive Years with Overweight or Obesity: A Randomized Controlled Trial. J Nutr. 2024 Apr;154(4):1347-1355. doi: 10.1016/j.tjnut.2024.02.009. Epub 2024 Feb 15.

    PMID: 38365118DERIVED

Related Links

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Shanon Casperson, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

June 28, 2017

Study Start

October 2, 2017

Primary Completion

April 14, 2023

Study Completion

April 14, 2023

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)