Low Carbohydrate High Fat Ketogenic vs. Non-ketogenic Diet

NCT04744558 | Completed

• 1 other identifier: 484-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this paper was to investigate and compare the effects of two iso-energetic hypo-caloric ketogenic hyper-ketonemic and non-ketogenic low carbohydrate high fat high cholesterol diets on body-composition, muscle strength and hormonal profile in experienced resistance-trained middle-aged men. Twenty non-competitive experienced resistance-trained middle-aged men were on the supervised calorie maintenance western diet and resistance-training regimen for 4 weeks and then divided into ketogenic and non-ketogenic groups for 8 weeks period. Keto bodies (β-hydroxybutyrate) levels were measured weekly, testosterone and insulin biweekly, strength and body-composition monthly, lipid profile and blood sugar level at the beginning and at the end of the study.

Conditions

Ketogenic Dieting

Keywords

Ketogenic diet; Testosterone; Insulin; Body-composition; Resistance-training; Middle-aged men

Outcome Measures

Primary Outcomes (1)

• Hormonal changes

  Testosterone, free testosterone and insulin assessment

  8 weeks

Secondary Outcomes (2)

• Body composition changes

  8 weeks

• Muscle strength changes

  8 weeks

Study Arms (2)

Ketogenic

EXPERIMENTAL

Low carb high fat ketogenic diet

Other: Low carb high fat ketogenic dieting

Non-ketogenic

ACTIVE COMPARATOR

Low carb high fat non-ketogenic diet

Other: Low carb high fat non-ketogenic dieting

Interventions

Low carb high fat ketogenic dieting OTHER

Macronutrient ratios for low carb high fat ketogenic diet were 20 %, 5 %, 75 % of protein, carbohydrates and fat, respectively. Caloric intake for experimental phase was set to cover basal metabolism and sedentary activities (BMR times 1.2) for every participant using the Mifflin St Jeor equation.

Ketogenic

Low carb high fat non-ketogenic dieting OTHER

Macronutrient ratios for low carb high fat non-ketogenic diet were 20 %, 15 %, 65 % of protein, carbohydrates and fat, respectively. Caloric intake for experimental phase was set to cover basal metabolism and sedentary activities (BMR times 1.2) for every participant using the Mifflin St Jeor equation.

Non-ketogenic

Eligibility Criteria

• Age: 40 Years - 45 Years
• Gender Eligibility Details: The study focused on strength-trained middle-aged men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Noncompliance to the diet, and the missing training schedule.

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Faculty of Sport and Physical Education

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Vladimir M Vidić, MSc

  Faculty of Sport and Physical Education, University of Belgrade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 9, 2021
• Study Start: September 1, 2019
• Primary Completion: November 24, 2019
• Study Completion: December 15, 2019
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

SE (1)