Last updated: 11/03/2018 23:34:43
Horlicks Cardia+: investigating the glycaemic index and satiety effect of Horlicks Cardia+
GSK study ID
205815
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
Official title: Horlicks Cardia+: investigating the glycaemic index and satiety effect of Horlicks Cardia+
Trial description: The purpose of this study is to determine the glycaemic index and satiety of the Fiber rich health drink.
Primary purpose:
Not applicable
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Comparison of Glycemic index (GI) of fiber rich health drink made up with water versus (vs.) standard glucose drink
Timeframe: At pre dose and up to 120 minutes post dose
Comparison of GI of fiber rich health drink made up with full-fat milk vs. standard glucose drink
Timeframe: At pre dose and up to 120 minutes post dose
Secondary outcomes:
Comparison of perceived satiety following consumption of Fiber rich health drink consumed with water vs. standard glucose drink
Timeframe: At pre dose and up to 120 minutes post dose
Comparison of perceived satiety following consumption of Fiber rich health drink consumed with full-fat milk vs. standard glucose drink
Timeframe: At pre dose and up to 120 minutes post dose
Interventions:
Other: Fiber rich health drink with water
Other: Glucose reference drink
Other: Fiber rich health drink with whole milk
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diet
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2017 to December 2017
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a
- signed and dated copy of the informed consent form
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study or Women who are breast-feeding
- Current (within 14 days of the start of the study) or regular use of any prescription, over-the-counter (OTC), herbal medicine unless the medication has been approved by
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Subject is male or female and have age of at least 40 years
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history. Do not currently have diabetes or a history of diabetes
- Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone or injectable progestogen or implants of levonorgestrel or estrogenic vaginal ring or percutaneous contraceptive patches or intrauterine device or intrauterine system or double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) or male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject
- Body Mass Index between 18.0-29.9 (kg/m2) inclusive
- Participants will be fully briefed prior to agreeing to participate in the study and the research team will confirm that they are willing, able and likely to comply with all procedures and complete the study
Exclusion criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study or Women who are breast-feeding
- Current (within 14 days of the start of the study) or regular use of any prescription, over-the-counter (OTC), herbal medicine unless the medication has been approved by the study physician. Vitamin supplements and occasional doses of OTC paracetamol for pain relief are permitted
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- Recent history (within the last 5 years) of alcohol or other substance abuse or Smoking habit
- Members of the investigators immediate family
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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