NCT04453254

Brief Summary

There is limited research on the amount of calories burned and metabolic differences of a complete supplemental meal in comparison to a whole food meal. The purpose of this study is to analyze the differences in calories burned and metabolic response post-consumption of a meal consisting of whole foods compared to its nutritionally engineered equivalent. Investigators hypothesize that energy expenditure and satiety will be greater following consumption of the whole food meal compared to the supplement meal, whereas, there will be no difference in levels of glucose between the two conditions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

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

April 15, 2013

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

16 days

First QC Date

June 26, 2020

Last Update Submit

April 5, 2024

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • Thermic effect of meals (TEM) also known as postprandial thermogenesis

    The total amount of calories burned after each meal will be measured using indirect calorimetry with the ventilated hood technique. Following meal ingestion, participants will rest quietly for 2 hours during which time their resting energy expenditure will be measured every other 15 minutes for 15 minutes. For example, they will have their resting energy expenditure measured during minutes 15-30, 45-60, 75-90 105-120 following meal ingestion.

    Baseline line, 15-30, 45-60, 75-90 105-120 minutes postprandial

Secondary Outcomes (2)

  • Change in blood glucose

    Baseline line, 30, 60, 90, 120 minutes postprandial

  • Change in self-reported feelings of hunger, fullness, satiation

    Baseline to 120 minutes postprandial

Study Arms (2)

Whole Food Meal

ACTIVE COMPARATOR

A whole meal consisting of 1 cup 2% milk, 1 cup Kashi Go Lean Original cereal, ¼ cup of almonds, ¼ cup of strawberries, and ¼ cup of raspberries.

Other: Whole Food Meal

Supplement Food Meal

ACTIVE COMPARATOR

A supplemental meal equivalent consisting of 1 cup 2% milk, 20 g whey protein, ½ EAS Myoplex bar, and ½ Balance bar.

Other: Supplement Food Meal

Interventions

Whole Food MealOTHER

Isocaloric/ macronutrient whole food meal

Whole Food Meal
Supplement Food MealOTHER

Isocaloric/ macronutrient supplement food meal

Supplement Food Meal

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young healthy females

You may not qualify if:

  • Participants with specific dietary needs.
  • Those with diabetes, impaired fasting glucose, low blood sugar (hypoglycemia) and participants who are classified as high risk.
  • Participants with lactose intolerance.
  • Participants who regularly use dietary supplements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Acheson KJ, Blondel-Lubrano A, Oguey-Araymon S, Beaumont M, Emady-Azar S, Ammon-Zufferey C, Monnard I, Pinaud S, Nielsen-Moennoz C, Bovetto L. Protein choices targeting thermogenesis and metabolism. Am J Clin Nutr. 2011 Mar;93(3):525-34. doi: 10.3945/ajcn.110.005850. Epub 2011 Jan 12.

    PMID: 21228266BACKGROUND

  • Bailey RL, Gahche JJ, Lentino CV, Dwyer JT, Engel JS, Thomas PR, Betz JM, Sempos CT, Picciano MF. Dietary supplement use in the United States, 2003-2006. J Nutr. 2011 Feb;141(2):261-6. doi: 10.3945/jn.110.133025. Epub 2010 Dec 22.

    PMID: 21178089BACKGROUND

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 1, 2020

Study Start

April 15, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share