Healthy volunteers
Conditions
Interventions
VLCD with a protein density of 4 %EN for 5 days
VLCD with a protein density of 4 %EN for 5 days
Sponsors
Juntendo University Graduate School of Health and Sports Science
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy female adults, aged 20 to 60 years 2. Subjects in good physical condition such that they can perform testing safely. 3. Subjects who are sedentary and not currently engaging in any regular exercise. 4. Subjects who agree to maintain their current level of activity throughout the trial period.
Exclusion criteria
Exclusion criteria: 1.Subjects who are smokers. 2.Subjects who have experienced more than 5% of weight loss in the past 3 months prior to the screening day 3.Subjects diagnosed with heart problems or disease 4.Subjects with uncontrolled hypertension (> 159 mmHg).Subjects with history of seizure 6.Present or history of neurological disorders or significant psychiatric illness 7.Subjects with gout 8.Subject with significant heart, liver, kidney, blood or respiratory disease 9.Subjects with Type I or Type II diabetes 10.Subjects with unstable thyroid disease 11.Subjects who participated in another clinical study within 3 months of the screening visit 12.Subjects with an allergy or sensitivity to vegetable, fruit or dairy product. 13.Subjects who use illicit drugs or have a history of alcohol or drug abuse within the past 6 months 14.Subjects who currently consume greater than 2 standard alcoholic drinks per day. 15.Subjects who have participated in a clinical research trial within 30 days prior to randomization. 16.Subjects who are cognitively impaired and/or who are unable to give informed consent 17.Subjects who are postmenopausal. 18.Subjects who have abnormal laboratory results or any other medical or psychological condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body composition | — |
Secondary
| Measure | Time frame |
|---|---|
| Mental status. | — |
Countries
Japan
Contacts
Public ContactYoshio Suzuki
Juntendo University Graduate School of Health and Sports Science
Outcome results
None listed