The Effect of Very Low Calorie Diet With and Without Exercise on Muscle Synthesis in Middle-aged Overweight Male.

NCT03116256 | Unknown

• 1 other identifier: B12092016
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this project are: to investigate the impact of VLCD on control of muscle protein synthesis, muscle structure and function, cardiac function (ejection fraction), vascular function (blood flow and capillary function), overall physiology status (cardiopulmonary function) and metabolic status (insulin sensitivity) in overweight and obese middle-aged male with or without exercises. There are 3 groups for the study, to which each participant will be randomly assigned into one of either:

1. 1.VLCD only
2. 2.VLCD with resistance exercise training (RET)
3. 3.VLCD with high intensity interval training (HIIT) The total duration of the intervention is six weeks, with exercises taking place three times per week at the research unit under close supervision by trained staff.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Assessment muscle protein synthesis (MPS) using fractional synthesis rate (FSR)

  FSR is calculated from the new alanine incorporation into muscle tissue (from muscle biopsy) in comparison to total D2O body water enrichment over a period of time. The total body D2O enrichment will be assessed from saliva collection, pre and post D2O consumption (few samples per week). As the investigators are planning for daily D2O top-up, the enrichment level hopefully would be stable within a certain level.

  Baseline, 3 week (midpoint) and post (6-week) intervention

Secondary Outcomes (14)

• Muscle protein breakdown (MPB)

  Baseline, 3 week (midpoint) and post (6-week) intervention

• Lipids profile

  Baseline, 3 week (midpoint) and post (6-week) intervention

• Total body skeletal muscle mass

  Baseline and post 6-week intervention

• Total lean body mass

  Baseline and post 6-week intervention

• Muscle structure

  Baseline and post 6-week intervention

Study Arms (3)

VLCD only

OTHER

Very low calorie diet (VLCD) only group- participants in this group will receive complete meal replacement for 6 weeks.

Dietary Supplement: Very low calorie diet (VLCD)

VLCD+RET

ACTIVE COMPARATOR

VLCD+RET group- participants in this group will receive complete meal replacement for 6 weeks and resistance exercise training 3 times every week for 6 weeks.

Dietary Supplement: Very low calorie diet (VLCD); Other: Resistance exercise training (RET)

VLCD+HIIT

ACTIVE COMPARATOR

VLCD+HIIT group- participants in this group will receive complete meal replacement for 6 weeks and High intensity interval training 3 times every week for 6 weeks.

Dietary Supplement: Very low calorie diet (VLCD); Other: High intensity interval training (HIIT)

Interventions

Very low calorie diet (VLCD) DIETARY_SUPPLEMENT

All participants (including exercise group) will be using full daily meal replacement during the 6-week interventional period. The total meal supplement is 600 kcal/day.

Also known as: LighterLife meal replacement

VLCD only; VLCD+HIIT; VLCD+RET

High intensity interval training (HIIT) OTHER

Participants in this group will be having HIIT session three times per week under close medical supervision. This involves 60 sec high intensity cycling at 95-125% Watt Max, with 90s recovery, repeated 5 times, with 2 minutes warm up and cool down.

VLCD+HIIT

Resistance exercise training (RET) OTHER

The exercise format will be 2 sets of 12 repetitions at 70% 1-RM for each resistance regime, with 1-2 minutes rest between sets after a prescribed warm-up 3 sessions/week. The resistance regimes are: (3 upper body)chest press, latissimus pull down, seated lever row; (3 lower body) leg extension, leg curl, leg press. Participants will be alternating between upper and lower body exercise during each training session.

Also known as: Weight training

VLCD+RET

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Male gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Age 30 to 60-year old
• BMI 27 to 50

You may not qualify if:

• Participation in a formal exercise regime more than 2 hours, twice per week
• Active cardiovascular disease: uncontrolled hypertension (BP \> 180/110), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event
• Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial), epilepsy
• Respiratory disease including: pulmonary hypertension, COPD, severe uncontrolled asthma,
• Diabetes mellitus.
• Active inflammatory bowel or renal disease
• Malignancy
• Clotting dysfunction
• Musculoskeletal or neurological disorders
• Family history of early (\<55y) death from cardiovascular disease
• Known sensitivity/ allergy to contrast Sonovue
• Any other ongoing acute or SIGNIFICANT chronic medical condition that is not mentioned above.
• Weight \>120kg (weight limit for DXA scan)

Sponsors & Collaborators

• University of Nottingham: lead
• University of Birmingham: collaborator

Study Sites (1)

MRC-ARUK Centre of Excellence for Musculoskeletal Ageing, School of Medicine, University of Nottingham,

Derby, Derbyshire, DE22 3DT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

High-Intensity Interval Training; Resistance Training

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Iskandar Idris

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hariz Aziz

CONTACT

+447729182321; stxmhab@nottingham.ac.uk

Iskandar Idris

CONTACT

iskandar.idris@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participant will be randomised into one of the following group: 1. VLCD (N=12), 2. VLCD + RET (N=12) 3. VLCD + HIIT (N=12)

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 17, 2017
• Study Start: January 9, 2017
• Primary Completion: May 31, 2019
• Study Completion: June 30, 2019
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

GB (1)