NCT01749449

Brief Summary

The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15% vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%; 28days) in overweight individuals. We hypothesize that HP will elicit more favorable body composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of change will be greatest in those consuming HP meals more frequently.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2005

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

Study Start

First participant enrolled

January 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
Last Updated

December 13, 2012

Status Verified

January 1, 2007

Enrollment Period

1.3 years

First QC Date

December 11, 2012

Last Update Submit

December 12, 2012

Conditions

Obesity

Keywords

high proteinhigh carbohydratemeal frequencyabdominal body fatpostprandial thermogenesis

Outcome Measures

Primary Outcomes (1)

  • body composition

    DXA was used to quantify changes in body composition over the 2 months

    2 months

Study Arms (3)

High protein 3 meals/day

EXPERIMENTAL

35% protein intake eaten as 3 meals per day

Other: protein and meal frequency

High carbohydrate consumed 3 meals/day

EXPERIMENTAL

High carbohydrate 3 meals/day

Other: protein and meal frequency

High protein consumed 6 meals/day

EXPERIMENTAL

35% protein 6 meals/day

Other: protein and meal frequency

Interventions

protein and meal frequencyOTHER

comparison of different levels of protein intake and meal frequency on body composition in obese adults

High carbohydrate consumed 3 meals/dayHigh protein 3 meals/dayHigh protein consumed 6 meals/day

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old,
  • overweight or obese but otherwise in good health

You may not qualify if:

  • cardiovascular disease,
  • cancer,
  • HTN,
  • type I or II DM,
  • food allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skidmore College

Saratoga Springs, New York, 12866, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Proteins

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Paul J Arciero, PhD

    Skidmore College

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 13, 2012

Study Start

January 1, 2005

Primary Completion

May 1, 2006

Study Completion

January 1, 2007

Last Updated

December 13, 2012

Record last verified: 2007-01

Locations

US(1)