Trial Outcomes & Findings for High-fat Meal Challenge in Pediatrics (NCT NCT05230433)

NCT ID: NCT05230433

Last Updated: 2025-09-29

Results Overview

Determine the number of participants that complete at least 75% of the shake (by weight).

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

10 minutes

Results posted on

2025-09-29

Participant Flow

Enrollment was completed in September 2022 (n=15). Recruitment followed D-H IRB approval. Adolescents (8-17 years) were recruited through the Children's Hospital at Dartmouth Hitchcock (assisted by Dr. Susanne Tanski), the Weight and Wellness Center (assisted by Dr. Auden McClure), and, as needed, through the community. Flyers have been developed by DHMC marketing.

No pre-assignment occurred.

Participant milestones

Participant milestones
Measure	High-fat Metabolic Challenge All participants consumed a high-fat agent at the second study visit. The shake was be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High-fat Meal Challenge in Pediatrics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-fat Metabolic Challenge n=15 Participants Participants will consume a high-fat agent one time, at the second study visit. High-fat Challenge: The shake will be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor.
Age, Continuous	14 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Body Mass Index	22.7 kg/m2 STANDARD_DEVIATION 6.1 • n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes

Determine the number of participants that complete at least 75% of the shake (by weight).

Outcome measures

Outcome measures
Measure	High-fat Metabolic Challenge n=15 Participants All participants consumed the high-fat challenge
Palatability of the High Fat Agent.	13 Participants

SECONDARY outcome

Timeframe: At baseline

BMI percentile calculated for each participant. Average and standard deviations were reported.

Outcome measures

Outcome measures
Measure	High-fat Metabolic Challenge n=15 Participants All participants consumed the high-fat challenge
BMI Percentile	70 percentile Standard Deviation 24

SECONDARY outcome

Timeframe: 60 and 180 minutes post consumption of high fat shake

Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported.

Outcome measures

Outcome measures
Measure	High-fat Metabolic Challenge n=15 Participants All participants consumed the high-fat challenge
Medium Chain Acylcarnitine Concentration Average MC acylcarnitine at 60 minutes	0.055 mircoM Standard Deviation 0.015
Medium Chain Acylcarnitine Concentration Average MC acylcarnitine at 180 minutes	0.061 mircoM Standard Deviation 0.014

SECONDARY outcome

Timeframe: 60 and 180 minutes post consumption of high fat shake

Outcome measures

Outcome measures
Measure	High-fat Metabolic Challenge n=15 Participants All participants consumed the high-fat challenge
Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes.	0.902 ratio Standard Deviation 0.021

Adverse Events

High-fat Metabolic Challenge

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Meijer

Happy Trails Nutrition

Phone: 6036505250

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place