A trial to determine:a) the effectiveness of fibre supplement, alpha-cyclodextrin, on cholesterol control in overweight and obese participants with pre diabetesb) the effectiveness of ginseng derivative, Compound K, on blood sugar control in overweight and obese participants with pre diabetes

Phase 3

Completed

• Conditions: Overweight; Obesity; Pre diabetes; Dyslipidaemia; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12614001302640
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-15
• Study Completion: 2019-03-29
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

*Aged 18 years or over
*BMI greater than or equal to 25
*Pre-diabetes (based on ADA guidelines, determined by bloods at the screening visit or 6 months prior to Screening):
- a fasting plasma glucose greater than or equal to 5.6 mmol/L AND/OR
- 2 hour post-challenge (oral glucose tolerance test) plasma glucose greater than or equal to 7.8 mmol/L AND/OR
- HbA1c greater than or equal to 5.7%

Exclusion Criteria

*Type 2 diabetes criteria are based on ADA guidelines. Participants will be excluded from the study if they have:
- a fasting plasma glucose greater than or equal to 7.0 mmol/L AND/OR
- 2 hour post-challenge (oral glucose tolerance test) plasma glucose greater than or equal to 11.1 mmol/L AND/OR
- HbA1c greater than or equal to 6.5%
*Use of lipid lowering medication
*Use of anti-diabetic medications for pre-diabetes
*Type 1 diabetes
*Unstable angina or recent onset of cardiovascular disease (within 1 month of screening)
*Bariatric surgery
*A history of significant liver, kidney or gastrointestinal disease AND/OR
- ALT or AST > 2.5 times upper limit of normal
- serum creatinine > 1.5 times upper limit of normal or
- eGFR < 60ml/min/1.73m^2 or presence of microalbuminuria
*Chronic diarrhoea, bowel motility problems, or other conditions that could affect intestinal fat absorption
*Untreated thyroid disease
*Greater than 10% change in body weight over the past 3 months
*Alcohol or illicit drug abuse
*Pregnant or breastfeeding women, and women who might be planning pregnancy during the duration of the study
*Use of weight loss medications and other drugs that may affect body weight e.g. anti-psychotics, anti-depressants, or corticosteroids
*Taking the following medications which may show reduced absorption of the investigational products: antibiotics, anticoagulants, anticonvulsants, antiarrhythmics, immunosuppressants, or any other drug that is necessary to take with a meal. Short-term and prophylactic antibiotics may be taken during study participation for up to 14 days, but they should be taken at least 2 hours apart from the study drug
*Commencement of a new prescription medication within 3 months of screening or change in dose regimen of a prescription medication within 1 month of screening
*A history or presence of malignancy [completely resected basal or squamous cell carcinoma of the skin if treatment completed > 6 months prior to enrolment and participants in remission for > 5 years prior to screening remain eligible]
*Inability to read and write English
*A history of frequently changed smoking habits, in addition to smoking cessation within 6 months prior to screening. Those who wish to take on the advice of a 'Quit' smoking programme at the time of screening will be eligible to start the trial after 6 months
*Participants may also be excluded, if in the opinion of the study investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the participant
*Participation in a clinical trial in the last month
*Unable to commit to the appointment schedule or perform the tasks required in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of alpha-cyclodextrin on cholesterol control in an overweight or obese group with pre-diabetes. A venous blood sample will be collected and total cholesterol will be determined by a commercial laboratory.[Month 6];To investigate the efficacy of hydrolysed ginseng extract (rich in Compound K) on glycaemic control in an overweight or obese group with pre-diabetes. A venous blood sample will be collected and fasting plasma glucose will be determined by a commercial laboratory.[Month 6]