Nutritional completeness of a ready-to-drink meal replacement in healthy adults Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 40 years 2. BMI between 22 and 30 kg/m^2 3. Apparently healthy, measured by questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders 4. Weight stable (no significant weight loss or gain in the past 6 months) 5. Reported alcohol consumption <= 10 units/week 6. Consumption of a normal UK diet, with the inclusion of 'junk food' at least once per week ('junk food' defined by the contracting group as take away meals, fast food, crisps, chocolate, ice cream) 7. Informed consent signed
Exclusion criteria
Exclusion criteria: 1. Subject has any health conditions that would prevent them from fulfilling the study requirements, put the subject at risk, or would confound the interpretation of the study results as judged by the Principal Investigator or Study Physician 2. Subjects with a significant current or previous medical history, as assessed by questionnaire 3. Subjects with a history of eating disorders 4. Subject has gastrointestinal malabsorption (from celiac disease, colitis, surgery, etc) 5. Medication: any medication that might affect the study measurements 6. Currently taking any vitamin or mineral supplements, or having taken these within the past 3 months 7. Subject has a known allergy or sensitivity to soy containing nutritional products 8. Complete Blood Count or Comprehensive Metabolic Profile values outside normal ranges, as assessed by the study physician 9. Participating in another clinical trial 10. Pregnant or breast feeding women 11. Not willing to use appropriate contraceptive methods to avoid pregnancy during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comprehensive metabolic profile is measured using a blood test at study day 1, day 15, day 30 2. Complete blood count is measured using a blood test at study day 1, day 15, day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight is measured using a scale at day 1, day 15, day 30 2. Lipid profile is measured using a blood test at day 1, day 15, day 30 3. Vitamin and mineral status is measured using a blood test at day 1, day 15, day 30 4. Fatty acid levels are measured using a blood test at day 1, day 15, day 30 5. Urinalysis is measured using a urine sample at day 1, day 15, day 30 6. Satiety/appetite/cravings are measured using self reported questionnaires (numerical scale of 1 "not at all" to 10 "very high") each day 7. Bowel movements are measured using self-reported ratings from the Bristol Stool Chart each day. 8. Self-reported subjective energy levels and wellness are measured using SF-12 each week | — |
Countries
United Kingdom