Acute Effects of DC7-2, a Meat Derived Octapeptide, on Appetite (SLIM8)

SLIM8 - Acute Effects of DC7-2 on Appetite

A double-blind, randomized crossover design with four arms including three experimental conditions and placebo will be applied. After having successfully completed screening procedures, eligible participants will be invited to four separate test days. The test days are separated with at least 7 days, however 4 days can be accepted for logistical reasons. During the entire course of the study, participants must remain weight stable and not change their diet or physical activity level. Significant changes in diet, physical activity level (evaluated by the sub-investigator) or weight change ±3 kg over the course of the study (from screening to completion of the last test day) results in exclusion of that subject.

Study Overview

• Status: Completed
• Conditions: Appetite; Lack or Loss, Nonorganic Origin
• Intervention / Treatment: Dietary supplement: DC7-2; Dietary supplement: DC7-2 + potato protein isolate; Dietary supplement: Potato protein isolate; Dietary supplement: Placebo

Detailed Description

For standardization, participants will be asked avoid excessive alcohol consumption (not above 1 unit and no alcohol at all from 8 pm the night before the test days) and intense physical activity 48 hours prior to the test day. Also, they will be asked to consume a standardized meal at home no later than 8 pm the night before the test days. This meal is prepared and delivered by the department.

Furthermore, the participants must arrive at the study facilities in the morning after an overnight fast (from 10 pm) using non strenuous means of transportation.

Over the course of the study (from screening (visit 1) to completion of the last test day (visit 5)), participants are not allowed to change body weight (±3 kg), diet or physical activity level (as judged by the sub-investigator). The participants will be weighed and asked about compliance with additional standardization before initiating each test day. Possible in-compliance with the standardization will be judged by the sub-investigator whether to result in rescheduling of the visit or to be recorded as a protocol deviation.

Participants arrive at the study facility in the morning. Compliance with standardization is controlled along with registration of possible adverse events and use of concomitant medications. During the test days, participants are settled together with other participants, but separated at individual tables. During the meals, participants are settled into individual feeding cubicles, where they cannot see each other and are instructed not to talk to each other. Visual analogue scales (VAS') will be completed for measurement of fasting subjective appetite levels.

The test products (capsules) will be provided prior to a standardized fixed breakfast, prior to a standardized fixed mid-morning snack and prior to an ad libitum meal. Immediately before and after each episode of capsules and food consumption and at 30 minutes intervals, VAS' will be completed. Energy intake will be calculated from the ad libitum meal.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 1958
    • Department of Human Nutrition, Faculty of Science, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy men
• Age between 18 and 65 years
• BMI between 27-35 kg/m2

Exclusion Criteria:

• Vegetarians
• Participants unable to consume or known to get nausea from consuming capsules
• Participants not able to comply with the study protocol, including consumption of the specific study foods (pictures of study foods shown at screening)
• Any known food allergies or food intolerance likely to affect the present study
• Weight change of ±3 kg two months prior to the study
• Vigorous physical activity more than 5 hours/week
• Alcohol intake above the recommendations from the Danish Health and Medicines Authority (>14 units/week)
• Substance abuse
• Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes, gum etc.). Irregular smokers accepted
• Use currently or within the previous 3 months of any medication or supplements known to affect appetite or body weight as judged by the investigators
• Chronic diseases (e.g. cancer, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders) or other relevant health problems as judged by the investigators
• Simultaneous or within the past month participation in other clinical studies
• Participant's general condition contraindicates participating in the study, as judged by the investigators or the medical expert

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: DC7-2 alone; Administration of DC7-2, a meat-derived octapeptide.	Dietary supplement: DC7-2; Effects on appetite
ACTIVE_COMPARATOR: DC7-2 + potato protein isolate; Administration of DC7-2, a meat-derived octapeptide, combined with potato protein isolate that protects DC7-2 from degradation in the GI tract.	Dietary supplement: DC7-2 + potato protein isolate; Effects on appetite
ACTIVE_COMPARATOR: Potato protein isolate + placebo; Administration of potato protein isolate combined with inactive whey protein as placebo.	Dietary supplement: Potato protein isolate; Effects on appetite
PLACEBO_COMPARATOR: Placebo; administration of inactive whey protein	Dietary supplement: Placebo; Inactive whey protein, not expected to affect appetite.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy intake	Assessment of ad libitum energy intake when exposed to one of the test products	360 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective appetite sensations	Evaluations of each of the subjective appetite sensations assessed by visual analogue scale (VAS) (satiety, fullness, hunger, prospective food consumption, thirst)	Six hours during each test day between test day 1, 2, 3, and 4 (acute effect)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palatability of meals	All three meals are rated for their palatability e.g. smell, taste and appearance	Directly after consumption of the three meals at all four test days
Subjective assessments of nausea and general wellbeing	VAS assessments for nausea and general wellbeing throughout the study test day	Six hours during each test day between test day 1, 2, 3, and 4 (acute effect)

Collaborators and Investigators

• Sponsor: Arne Astrup
• Investigators: Principal Investigator: Arne Astrup, Professor, MD DMSc, Department of Nutrition, Exercise and Sports, Research Centre Opus, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2017
• Primary Completion (ACTUAL): December 7, 2017
• Study Completion (ACTUAL): December 7, 2017

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (ACTUAL): March 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Peptide; Satiety; Appetite; Encapsulation; Energy intake; Hunger
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Anorexia
• Other Study ID Numbers: B330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No