Effects of Ketones on Muscle Wasting During Caloric Restriction in Lean Females

NCT04744142 | Completed

• 1 other identifier: S61133
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Because of these anabolic properties of ketone bodies and the fact that ketone bodies prevent muscle protein breakdown for gluconeogenesis during energetic stress, ketone bodies can be a promising strategy to prevent or treat skeletal muscle wasting. Therefore, our aim is to investigate the effect of 3HHB intake on muscle wasting and its adverse consequences during a period of caloric restriction in lean females. In addition, we compare the effects of 3HHB intake with a high protein diet, which is currently considered as the best strategy to minimize lean loss during hypo-energetic periods. To end, we aim to investigate the synergistic effects of the intake of 3HHB in combination with a high protein diet.

Conditions

Muscle Wasting; Protein Intake; Ketosis; Caloric Restriction

Keywords

resting metabolic rate; β-hydroxybutyrate; caloric restriction; muscle mass; ketone ester

Outcome Measures

Primary Outcomes (1)

• Muscle mass

  The amount of muscle mass loss

  Muscle mass is measured before and after 4 weeks of caloric restriction

Study Arms (4)

Placebo

NO INTERVENTION

Received 10% protein in nutrition + placebo supplement

Ketone

EXPERIMENTAL

Received 10% protein in nutrition + 3x20g B-hydroxybutyrate per day

Drug: Ketone supplementation

High protein

EXPERIMENTAL

Received 30% protein in nutrition + placebo supplement

Dietary Supplement: Increased protein intake

High protein + ketone

EXPERIMENTAL

Received 30% protein in nutrition + 3x20g B-hydroxybutyrate per day

Drug: Ketone supplementation; Dietary Supplement: Increased protein intake

Interventions

Ketone supplementation DRUG

Subjects receive either placebo or ketone ester supplementation

Also known as: Placebo vs ketone supplementation

High protein + ketone; Ketone

Increased protein intake DIETARY_SUPPLEMENT

Subjects receive either normal or increased protein intake

Also known as: Normal vs increased protein intake

High protein; High protein + ketone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females between 18 and 40 years old
• Fat percentage between 16 and 25%
• Regularly involved in physical activity ( \> 6 h/week)
• Use of hormonal contraceptives
• Good health status confirmed by a medical screening
• Stable body weight during the last 3 months prior to the study, i.e. no changes \> 2 kg

You may not qualify if:

• Smoking
• Obsessive pursuit for thinness, evaluated by the Eating Disorder Inventory 3 (EDI-3) 'Pursuit of leanness' (i.e a score higher than 26/32) (see Appendix 5)
• Intake of any medication or nutritional supplement that is proven to affect exercise performance, except oral contraceptives
• Blood donation during the study
• Current participation in another research trial
• Any other argument to believe that the subject is unlikely to successfully complete the full study protocol

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams-brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Muscular Atrophy; Ketosis

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Katrien Koppo, PhD

  KU Leuven

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects were randomized by an external, independent researcher. Supplements were color and taste matched.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects were pair-matched for body weight, % body fat and energy intake, where after they were randomly allocated to an experimental group

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 8, 2021
• Study Start: January 1, 2018
• Primary Completion: December 20, 2018
• Study Completion: June 1, 2019
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)