NCT04629365

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

November 9, 2020

Last Update Submit

November 13, 2020

Conditions

Diet, HealthyBody Weight

Keywords

ketogenic dietbody buildersathletesbody compositionhormones

Outcome Measures

Primary Outcomes (3)

  • Fat Mass

    fat mass measured through body impedence analyser

    8 weeks

  • Lean Body Mass

    lean body mass mass measured through body impedence analyser

    8 weeks

  • Maximal muscle strength

    muscle strength measured via 1-RM test

    8 weeks

Secondary Outcomes (4)

  • blood glucose

    8 weeks

  • testosterone

    8 weeks

  • inflammatory cytokines

    8 weeks

  • resting metabolism

    8 weeks

Study Arms (2)

Ketogenic Diet

EXPERIMENTAL

KD group consumed less than 50g/day of carbohydrates

Other: Ketogenic Diet

Normal Diet

ACTIVE COMPARATOR

ND group consumed 55% of the caloric intake from carbohydrates

Other: Normal Diet

Interventions

Ketogenic DietOTHER

KD group consumed less than 50g/day of carbohydrates

Ketogenic Diet
Normal DietOTHER

ND group consumed 55% of the caloric intake from carbohydrates

Normal Diet

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, 35131, Italy

Location

MeSH Terms

Conditions

Body Weight

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Antonio Paoli, MD

    University of Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor treated anonymus data
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 16, 2020

Study Start

January 1, 2020

Primary Completion

August 31, 2020

Study Completion

October 31, 2020

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

IT(1)