Short term effects of supplementing the amino acid, leucine during weight loss on improvements in body composition and insulin sensitivity in individuals at risk of the metabolic syndrome.

A pilot trial on the short term effects of leucine supplementation during weight loss, on body composition, insulin sensitivity and metabolic flexibility in the metabolic syndrome.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001528448

Enrollment

Registered

2016-11-07

Start date

2013-08-05

Completion date

2014-05-04

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a pilot trial of 8 weeks duration examining whether additional supplementation of leucine (3 grams/day) during calorie restriction is better than weight loss alone in reducing fat loss and muscle loss. The hypothesis is that leucine will improve muscle mass retention and increase fat loss, hence improving insulin action. We envisage an improved body composition that will favour those at risk of metabolic syndrome to reduce their risk of type 2 diabetes and cardiovascular disease.

Interventions

Double blinded, randomized controlled trial. All subjects will be prescribed individualized diets. Energy requirements will assessed at baseline by measuring resting metabolic rate and using an activity factor of 1.5 for men/ 1.3 for women. Subjects will be prescribed 75% of their estimated energy requirements. Dietary composition will follow NHMRC dietary guidelines except for dairy products which will be restricted to 1 serve per day and meat intake that will prescribed at no more than 3 serves/week for men and 2 serves/ week for women. Participants will be provided with the two weeks menu with recipe cards so they can prepare their own meals at home. Study duration: 8-week program. Study diets: All diets are restricted in energy intake. Daily Diet composition will be 65% carbohydrate, 20% protein, 15% Fat Control group: Control diet plus placebo (lactose) oral capsules (~3 grams/day) Experimental group: Control diet plus leucine oral capsules(~3 grams/day) Both placebo and leucine capsules made up by Pharmacy 777. Each participant will be called for fortnightly visits to check their diet and capsule compliance. Diet Compliance will be checked in oral discussion and any issues will be sorted. Capsule compliance will be done by checking self reported capsule fill-in form. At the end of trial all will be asked to fill in food questionaire which can be compared with the prescribed intake. Capsule count will be done at each 4 weeks when they return empty container and self reported form.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

Adult Australian men and women with abdominal obesity and at least one other criteria for MetS as judged by recent consensus guidelines (Alberti et al, 2009), aged 20- 65 years, of European origin, Not on calcium or vitamin supplements. Medications like lipid lowering therapy and hypertension will be quantified and monitored.

Exclusion criteria

any history of MI, stroke, T1DM or weight loss in previous 6 months,on medication that affects body composition, energy expenditure or food intake will be excluded

Outcome results