POlyphenol CardioMetabolic Outcomes Study: The effects of green tea and coffee extracts on glucose metabolism and cardiovascular function in overweight and obese women with Polycystic Ovary Syndrome (PCOS) and insulin resistance

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome (PCOS), overweight/obesity and insulin resistance; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN37548161
• Lead Sponsor: Medical Research Council - Human Nutrition Research (UK)

Brief Summary

2015 results presented at Experimental Biology conference in https://www.fasebj.org/doi/abs/10.1096/fasebj.29.1_supplement.lb271 (added 25/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-11-27
• Study Start: 2014-04-16
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

1. Otherwise healthy
2. Pre-menopausal, overweight or obese women (BMI = 25 kg/m2)
3. Aged16-45 years
4. With PCOS and insulin resistance (fasting insulin = 50 pmol/L)

Exclusion Criteria

1. Smoking
2. History of substance abuse or alcohol consumption >14 units per week
3. Allergy or intolerance to the study supplements and/or foods
4. Professional athletes or those with self-reported high physical activity
5. Chronic, acute or active metabolic (including type 1 and type 2 diabetes mellitus) and inflammatory conditions, haematological disorders, or any other systemic illness of renal, hepatic or gastrointestinal origin
6. Active cancer or diagnosis of malignancy within the last five years
7. Major surgical operations interfering with the study outcomes within three months of screening
8. Medical treatment with the following agents: weight reduction medicines, insulin sensitizers, hormonal therapy, antihypertensive medicines, anti-dyslipidaemic agents, nitrate-derived agents, psychiatric drugs (only excluded if dose had been started/changed in the previous six months) or any other medication known to affect glucose/insulin metabolism, vascular/endothelial function, gastrointestinal system or central nervous system
9. Weight change > 10% over the last six months
10. Endocrine disorders such as adrenal hyperplasia, hyperprolactinaemia, Cushing?s syndrome, androgenic tumours, late onset of 21-hydroxylase deficiency, abnormal thyroid function or any other ovarian, adrenal or pituitary disorder not associated with PCOS
11. Pregnant, lactating, contemplating pregnancy or undergoing treatment to achieve pregnancy
12. Regular consumption of micronutrient and/or herbal and/or polyphenol supplements known to have an impact on insulin sensitivity/secretion and/or vascular/endothelial function

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity and secretion were measured at baseline (week 0), post-placebo (week 8) and post-intervention (week 16) time points via the Oral Dose Intravenous Labelled Glucose Experiment (ODILE) protocol. The ODILE protocol is similar to the Oral Glucose Tolerance Test (OGTT), but it is modified by the addition of an intravenous dose of [1]-13C-glucose (labelled glucose) administered 45 minutes after the oral glucose dose was consumed (40 blood samples are taken over a 4-hour and 45 minute period). Gas chromatography/combustion/isotope ratio mass spectrometry (GC/C/IRMS) is used for isotopic composition and the results are interpreted using a stable-label two compartment minimal model (2CMM). This mathematical modelling allows for the determination of glucose effectiveness and insulin sensitivity parameters. Insulin and C-peptide data obtained from the same protocol were also modelled to obtain information about insulin secretion.