Impact of High Energy Nutritional Supplement Drink (HENSD) consumed for five consecutive days on appetite, energy intake, and risk factors of cardiovascular diseases and type 2 diabetes

Impact of High Energy Nutritional Supplement Drink (HENSD) consumed for five consecutive days on appetite, energy intake and cardiometabolic risk factors in underweight females

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12092733

Enrollment

Registered

2014-03-12

Start date

2014-02-12

Completion date

Unknown

Last updated

2017-02-27

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

Conditions

High Energy Nutritional Supplement Drinks Nutritional, Metabolic, Endocrine

Interventions

During 5 days participants in the evening will consume: 1. HENSD (Scandishake, Chocolate, Nutricia) made up with 240 g of full fat milk, according to the manufacturer instructions (Nutricia, 2009)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy women with body mass index of 17- 20 kg/m2 2. The participants have a stable weight for one month prior to the study 3. The participants have regular menstrual cycle

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. History of eating disorder 3. History of gastrointestinal problems or surgery 4. History of some allergy 5. History of chronic illness 6. On any medication 7. On nutritional supplements 8. Following specific diet 9. Currently taking part in other research

Design outcomes

Primary

Measure	Time frame
1. Fasting lipids, postprandial lipaemia, insulin resistance - The determination of total cholesterol, triacylglycerol, high density lipoproteins will be performed on an automated Roche Cobas Mira Plus spectrophotometric analyser (Cobas Mira Plus (ABX Diagnostics, France), by enzymatic calorimetric method using commercially available kits (ABX Pentra, Horiba ABX, France). Quantitative insulin analysis will be performed by using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Mercodia AB, Uppsala Sweden) and plasma glucose will be analysed using a commercial assay kit (Life Sciences, Cambridge, UK) and an automated Cobas Mira biochemical analyser. 2. Energy intake and body mass - For measurement of rate of energy expenditure (EE) a ventilated hood system (Oxycon Pro, Jaeger GmbH, Hoechberg, Germany) will be used. On day 6, the participants will be requested to come to the metabolic room at the Human Nutrition Section (School of Medicine, College of Medical Veterinary and Life Sciences, Glasgow, UK) at ~ 08:30am in a fasted state. Participant height, body weight and fat mass will be measured and fasting blood samples will be collected. Then approximately 10-15 minutes will be given to the participant to rest and acclimatize with the environment. Subsequently metabolic rate will be measured for a duration of 20 minutes. The participants will be asked to consume ad libitum buffet breakfast and lunch. Following breakfast and lunch blood samples will be collected at 30, 60, 90 and 120 minutes. Immediately at all time points at which blood samples will be collected following breakfast and lunch appetite will be measured using visual analogue scales. In addition, the rate of energy expenditure (EE) for the duration of 20 minutes will be measured at all time points after breakfast and lunch. The amount of food offered and leftover during ad libitum buffet breakfast and ad libitum buffet lunch will be recorded by the researcher. Body height will be	—

Measure

Time frame

1. Fasting lipids, postprandial lipaemia, insulin resistance - The determination of total cholesterol, triacylglycerol, high density lipoproteins will be performed on an automated Roche Cobas Mira Plus spectrophotometric analyser (Cobas Mira Plus (ABX Diagnostics, France), by enzymatic calorimetric method using commercially available kits (ABX Pentra, Horiba ABX, France). Quantitative insulin analysis will be performed by using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Mercodia AB, Uppsala Sweden) and plasma glucose will be analysed using a commercial assay kit (Life Sciences, Cambridge, UK) and an automated Cobas Mira biochemical analyser. 2. Energy intake and body mass - For measurement of rate of energy expenditure (EE) a ventilated hood system (Oxycon Pro, Jaeger GmbH, Hoechberg, Germany) will be used. On day 6, the participants will be requested to come to the metabolic room at the Human Nutrition Section (School of Medicine, College of Medical Veterinary and Life Sciences, Glasgow, UK) at ~ 08:30am in a fasted state. Participant height, body weight and fat mass will be measured and fasting blood samples will be collected. Then approximately 10-15 minutes will be given to the participant to rest and acclimatize with the environment. Subsequently metabolic rate will be measured for a duration of 20 minutes. The participants will be asked to consume ad libitum buffet breakfast and lunch. Following breakfast and lunch blood samples will be collected at 30, 60, 90 and 120 minutes. Immediately at all time points at which blood samples will be collected following breakfast and lunch appetite will be measured using visual analogue scales. In addition, the rate of energy expenditure (EE) for the duration of 20 minutes will be measured at all time points after breakfast and lunch. The amount of food offered and leftover during ad libitum buffet breakfast and ad libitum buffet lunch will be recorded by the researcher. Body height will be

—

Secondary

Measure	Time frame
1. Appetite measures - appetite sensations will be measured with validated appetite questionnaires (Flint, Raben et al. 2000). Venous blood samples will be collected in 9 ml vacutainers containing EDTA and then appropriately treated with chemicals prior to preparation of plasma. 2. Metabolic rate	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026