Trial Outcomes & Findings for The Effect of Macronutrients on Satiety and Gut Hormone Responses (NCT NCT03466047)

Last Updated: 2020-10-20

Results Overview

3 hours AUC for different gut hormones (PYY) to determine the response to macronutrients in different release (stomach vs small intestine) locations. AUC for timepoints 0, 30min, 60min, 120min, 180min.

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

3 hours

Results posted on

2020-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Interventions 6 interventions
Protein Stomach (1day) STARTED	8
Protein Stomach (1day) COMPLETED	8
Protein Stomach (1day) NOT COMPLETED	0
Protein Small Intestine (1 Day) STARTED	8
Protein Small Intestine (1 Day) COMPLETED	8
Protein Small Intestine (1 Day) NOT COMPLETED	0
CHO Stomach (1 Day) STARTED	8
CHO Stomach (1 Day) COMPLETED	8
CHO Stomach (1 Day) NOT COMPLETED	0
CHO Small Intestine (1 Day) STARTED	8
CHO Small Intestine (1 Day) COMPLETED	8
CHO Small Intestine (1 Day) NOT COMPLETED	0
Fat Stomach (1 Day) STARTED	8
Fat Stomach (1 Day) COMPLETED	8
Fat Stomach (1 Day) NOT COMPLETED	0
Fat Small Intestine (1 Day) STARTED	8
Fat Small Intestine (1 Day) COMPLETED	8
Fat Small Intestine (1 Day) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Macronutrients on Satiety and Gut Hormone Responses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventions n=8 Participants Encapsulated macronutrients in a drink, 6 experiments, Protein released in the stomach (1 day), Protein released in the small intestine (1 day), CHO released in the stomach (1 day), CHO released in the small intestine (1 day), Fat released in the stomach (1 day), fat released in the small intestine (1 day).
Age, Continuous	28.8 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex/Gender, Customized Women	3 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	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Ireland	8 participants n=5 Participants
Weight	81.8 kg STANDARD_DEVIATION 7.2 • n=5 Participants

PRIMARY outcome

Timeframe: 3 hours

Outcome measures

Outcome measures
Measure	Protein Stomach n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink	Fat Stomach n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink	CHO Stomach n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink	Protein Distal Small Intestine n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink	Fat Distal Small Intestine n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink	CHO Distal Small Intestine n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink
The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract	1310 pg*min/mL Standard Error 102	1073 pg*min/mL Standard Error 154	1118 pg*min/mL Standard Error 150	1188 pg*min/mL Standard Error 121	1725 pg*min/mL Standard Error 351	1194 pg*min/mL Standard Error 221

SECONDARY outcome

Timeframe: 3 hours

Food intake as assessed with ad libitum lunch 3 hours after intervention

Outcome measures

Outcome measures
Measure	Protein Stomach n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink	Fat Stomach n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink	CHO Stomach n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink	Protein Distal Small Intestine n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink	Fat Distal Small Intestine n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink	CHO Distal Small Intestine n=8 Participants encapsulated protein made up into a flavored water drink A single macronutrient captured in microcapsules: Encapsulated macronutrients in a drink
Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake	3138 kj Standard Deviation 175	3389 kj Standard Deviation 161	3146 kj Standard Deviation 168	3008 kj Standard Deviation 192	3690 kj Standard Deviation 170	2305 kj Standard Deviation 183

SECONDARY outcome

Timeframe: 180min

Visual Analogue Scale ratings of hunger at 180 min (before the meal). The scale is 10cm line with two anchors at each end. Scores are recorded by making a handwritten mark that represents a continuum between "not hungry at all" and "Extremly hungry." The score of 0 represents least hunger. The score of 10 represent extreme hunger.