Experimental Overfeeding in Humans

NCT ID: NCT04065243

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2023-01-01

Brief Summary

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

Detailed Description

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The homeostatic regulation of body weight implies that biological processes have evolved to protect energy stores from changes to the food environment. Accordingly, many individuals remain remarkably weight stable over years without carefully considering how much they eat or how much energy they expend, which has given rise to the theory that body weight is regulated around an individual biological 'set point'. Notably, overfeeding humans in experimentally controlled conditions, support this phenomenon, but the underlying mechanisms are unknown.

To systematically map out the components of the overfed state, the investigators will execute a 2-week randomized controlled overfeeding trial in lean and overweight individuals. The trial is preceded by a 1-week lead-in period and followed by a 2-wk controlled ad libitum study period. The comparison between lean and overweight subjects, men and women, enables the determination of whether a differential response in overfeeding-induced signals is present in relation to BMI and sex.

Conditions

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Overfed Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Body weight and other anthropometric data are not masked.

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Isocaloric diet

Intervention Type OTHER

Two weeks of isocaloric weight maintenance

Overfed group

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

Group Type EXPERIMENTAL

Overfeeding diet

Intervention Type OTHER

Two weeks of overfeeding

Interventions

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Overfeeding diet

Two weeks of overfeeding

Intervention Type OTHER

Isocaloric diet

Two weeks of isocaloric weight maintenance

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female otherwise healthy subjects
* 20-40 years of age
* BMI (Body mass index) between 22-30 kg/m2

Exclusion Criteria

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

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Christoffer Clemmensen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoffer Clemmensen, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Assoc. prof. NNF Center for Basic Metabolic Research

Locations

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University of Copenhagen

Copenhagen, Norrebro, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ExpO

Identifier Type: -

Identifier Source: org_study_id

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