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

NCT03089190 | Completed DMC

• 1 other identifier: B330
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Appetite; Lack or Loss, Nonorganic Origin

Keywords

Appetite; Satiety; Energy intake; Hunger; Peptide; Encapsulation

Outcome Measures

Primary Outcomes (1)

• Energy intake

  Assessment of ad libitum energy intake when exposed to one of the test products

  360 min

Secondary Outcomes (1)

• Subjective appetite sensations

  Six hours during each test day between test day 1, 2, 3, and 4 (acute effect)

Other Outcomes (2)

• Palatability of meals

  Directly after consumption of the three meals at all four test days

• Subjective assessments of nausea and general wellbeing

  Six hours during each test day between test day 1, 2, 3, and 4 (acute effect)

Study Arms (4)

DC7-2 alone

ACTIVE COMPARATOR

Administration of DC7-2, a meat-derived octapeptide.

Dietary Supplement: DC7-2

DC7-2 + potato protein isolate

ACTIVE COMPARATOR

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

Potato protein isolate + placebo

ACTIVE COMPARATOR

Administration of potato protein isolate combined with inactive whey protein as placebo.

Dietary Supplement: Potato protein isolate

Placebo

PLACEBO COMPARATOR

administration of inactive whey protein

Dietary Supplement: Placebo

Interventions

DC7-2 DIETARY_SUPPLEMENT

Effects on appetite

DC7-2 alone

DC7-2 + potato protein isolate DIETARY_SUPPLEMENT

Effects on appetite

DC7-2 + potato protein isolate

Potato protein isolate DIETARY_SUPPLEMENT

Effects on appetite

Potato protein isolate + placebo

Placebo DIETARY_SUPPLEMENT

Inactive whey protein, not expected to affect appetite.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Selfreporting
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arne Astrup: lead

Study Sites (1)

Department Of Human Nutrition, Faculty of Science, University of Copenhagen

Frederiksberg, 1958, Denmark

Location

Study Officials

• Arne Astrup, Professor, MD DMSc

  Department of Nutrition, Exercise and Sports, Research Centre Opus, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department, Professor MD DMSc

Model Details: A double-blind, randomized crossover design with four arms including three experimental conditions and placebo

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 24, 2017
• Study Start: August 21, 2017
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)