Experimental Overfeeding in Humans

NCT04065243 | Completed

• 1 other identifier: ExpO
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the homeostatic mechanisms that counteract weight gain in response to experimental overfeeding.

Conditions

Overfed; Obesity

Outcome Measures

Primary Outcomes (2)

• Changes in blood protein patterns using proteomics 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding

  Blood will be collected for proteomics at screening, at baseline, during the overfeeding intervention and during the 2-week ad libitum intervention. Samples will be measured using LCMS instrumentation consisting of a nanoelectrospray ion source to a Q Exactive HF mass spectrometer.

  5 weeks

• Changes in blood peptide patterns using peptidomics 1 week before, during 2 weeks of overfeeding and 2 weeks after overfeeding

  Blood will be collected for peptidomics at screening, at baseline, during the overfeeding intervention and during the 2-week ad libitum intervention. Samples will be measured using LCMS instrumentation consisting of a nanoelectrospray ion source to a Q Exactive HF mass spectrometer.

  5 weeks

Secondary Outcomes (9)

• Body weight

  5 weeks

• Fat biopsy from subcutaneous adipose tissue before and after 2 weeks of overfeeding

  2 weeks

• Microdialysate from subcutaneous adipose tissue before and after 2 weeks of overfeeding. The samples will be used for detection of known and unknown secreted factors

  2 weeks

• Body composition in 40 subjects before and after overfeeding

  3 weeks

• Mixed meal test

  2 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

Subjects in this group will have a daily energy intake equivalent of 100 % of their calculated normal daily energy intake.

Other: Isocaloric diet

Overfed group

EXPERIMENTAL

Subjects in this group will have a daily energy intake equivalent of 150 % of their calculated normal daily energy intake.

Other: Overfeeding diet

Interventions

Overfeeding diet OTHER

Two weeks of overfeeding

Overfed group

Isocaloric diet OTHER

Two weeks of isocaloric weight maintenance

Control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female otherwise healthy subjects
• years of age
• BMI (Body mass index) between 22-30 kg/m2

You may not qualify if:

• Present or previous cardiovascular disease, diabetes or thyroid-disease
• smoking
• more than 3 hours of planned physical activity per week

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, Norrebro, 2200, Denmark

Location

MeSH Terms

Conditions

Overnutrition; Obesity

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Overweight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoffer Clemmensen, Assoc. Prof.

  Assoc. prof. NNF Center for Basic Metabolic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Body weight and other anthropometric data are not masked.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 22, 2019
• Study Start: August 22, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

DK (1)