NCT02211599

Brief Summary

The purpose of the study is to determine how adding a carbohydrate beverage to a meal with different protein levels affects the rate at which one's body burns fats, sugars, and proteins.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

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

August 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

1.6 years

First QC Date

August 5, 2014

Last Update Submit

January 18, 2022

Conditions

Postprandial Effect of Carbohydrate Beverage Consumption

Keywords

proteincarbohydratelipidoxidationfatsugarjuiceobesity

Outcome Measures

Primary Outcomes (1)

  • Postprandial lipid oxidation rate

    4 hours after meal consumption

Secondary Outcomes (3)

  • Energy expenditure measured by postprandial thermogenesis

    4 hours after meal consumption

  • Postprandial protein oxidation

    4 hours after meal consumption

  • Postprandial carbohydrate oxidation

    4 hours after meal consumption

Study Arms (2)

15% protein meal and sweetened beverage

EXPERIMENTAL

Breakfast and lunch will each contain 15% protein. A sweetened flavored beverage will be served with each meal; one drink will be sweetened with sugar and the other with sucralose (a non-nutritive sweetener). Order will be randomized.

Other: 15% proteinOther: Sweetened beverage

30% protein meal and sweetened beverage

EXPERIMENTAL

Breakfast and lunch will each contain 30% protein. A sweetened flavored beverage will be served with each meal; one drink will be sweetened with sugar and the other with sucralose (a non-nutritive sweetener). Order will be randomized.

Other: 30% proteinOther: Sweetened beverage

Interventions

15% proteinOTHER

Meal to provide 15%en from protein.

15% protein meal and sweetened beverage
30% proteinOTHER

Meal to provide 30%en from protein.

30% protein meal and sweetened beverage
Sweetened beverageOTHER

Beverage sweetened with either sugar (sucrose) or sucralose (non-nutritive sweetener).

15% protein meal and sweetened beverage30% protein meal and sweetened beverage

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI less than 25 kg/m2
  • ability to sign the consent form
  • availability of transportation

You may not qualify if:

  • percent body fat greater than or equal to 25% for males and 35% for females
  • allergies to any study foods
  • more than a 10% change in body weight within the past 2 months
  • current or planned pregnancy
  • lactation
  • metabolic illness/disease(s)
  • active cancer or in short-term remission (less than 3 years)
  • infectious diseases
  • alcohol or drug abuse
  • tobacco use
  • presence of acute illness
  • 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)

  • Casperson SL, Hall C, Roemmich JN. Postprandial energy metabolism and substrate oxidation in response to the inclusion of a sugar- or non-nutritive sweetened beverage with meals differing in protein content. BMC Nutr. 2017 Jul 21;3:49. doi: 10.1186/s40795-017-0170-2. eCollection 2017.

    PMID: 32153829DERIVED

MeSH Terms

Conditions

Platelet Glycoprotein IV DeficiencyObesity

Interventions

ProteinsSugar-Sweetened Beverages

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Shanon Casperson, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

  • James Roemmich, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 7, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)