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CompletedNCT04629365Updated Nov 17, 2020

Effects of Ketogenic Diet in Body Builders

An interventional study of Ketogenic Diet and Normal Diet in Diet, Healthy and Body Weight, sponsored by University of Padova. Completed at 1 site in Italy. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-17.

Sponsored by University of Padova · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2020, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study summary

the study sought to investigate the influence of 8 weeks of a very low carbohydrate ketogenic diet on body composition, muscle strength, muscle area and blood parameters in competitive natural body builders.

Read the detailed description

nineteen natural body builders were randomly assigned to a ketogenic diet (KD) group or to a normal diet group (ND) with a traditional meal pattern. The two diets were isocaloric and included the same amount of protein per kg of body weight; but differed in the distribution of fats and carbohydrates; the latter were kept below 5% daily (less than 50g/day) in the KD group while represented 55% of the caloric intake in the WD group During the experimental period, training loads were similar in the two groups. Athletes were tested before and after 8 weeks of the intervention. Body composition , basal metabolism, muscle strength and blood parameters were measured.

02

Conditions studied

  • Diet, Healthy
  • Body Weight

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Keywords

  • ketogenic diet
  • body builders
  • athletes
  • body composition
  • hormones
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 19 is below the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • at least 5 years of training experiences
  • competing in recognized body building category

Exclusion criteria

Exclusion Criteria:

  • adherence to special diets
  • use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement)
  • use of medications (steroids)
  • diabetes or metabolic diseases
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Ketogenic Diet

    KD group consumed less than 50g/day of carbohydrates

    Other: Ketogenic Diet

  • Active comparator
    Normal Diet

    ND group consumed 55% of the caloric intake from carbohydrates

    Other: Normal Diet

Interventions

  • OtherKetogenic Diet

    KD group consumed less than 50g/day of carbohydrates

  • OtherNormal Diet

    ND group consumed 55% of the caloric intake from carbohydrates

06

What researchers measure

Primary outcomes

  1. Fat Mass

    fat mass measured through body impedence analyser

    Time frame: 8 weeks

  2. Lean Body Mass

    lean body mass mass measured through body impedence analyser

    Time frame: 8 weeks

  3. Maximal muscle strength

    muscle strength measured via 1-RM test

    Time frame: 8 weeks

Secondary outcomes

  1. blood glucose

    glucose as milligram per deciliter

    Time frame: 8 weeks

  2. testosterone

    Testosterone free as picogram per milliliter

    Time frame: 8 weeks

  3. inflammatory cytokines

    IL6, IL1β, TNFα measured as nanogram per deciliter

    Time frame: 8 weeks

  4. resting metabolism

    resting energy expenditure measured as Kcal / day

    Time frame: 8 weeks

07

Study locations

1 site
  • Nutrition and Exercise Lab, DSB, University of Padova
    Padova, 35131, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04629365
Lead sponsor
University of Padova
Responsible party
Antonio Paoli (Full Professor, University of Padova) — Principal investigator
First posted
Nov 16, 2020
Start date
Jan 1, 2020
Primary completion
Aug 31, 2020
Completion
Oct 31, 2020
Last update
Nov 17, 2020

Study contacts

Antonio Paoli, MD
principal investigator · University of Padova

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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