Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Overweight

Syndrome

Obesity

Polycystic Ovary Syndrome

Overnutrition

Nutrition Disorders

Body Weight

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.

Participants in this group will receive a general lifestyle counseling.

Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm).

Time Restricted Feeding

Participants receive a general lifestyle counseling.

Usual care

Changqin Liu, MD

The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced energy restriction.

Intermittent fasting regimens involve periods fasting followed by periods of eating freely. Time-Restricted Feeding (TRF) is a new form of intermittent fasting and involves shortening the eating window to 4-10 h/day. TRF is a safe lifestyle intervention for weight loss in adults with obesity. Accumulating evidence suggests that TRF is an effective means of decreasing body weight and improving insulin resistance but did not have any negative impact on eating disorder symptoms, body image perception, or eating behaviors. Polycystic ovary syndrome (PCOS) is the most common endocrine condition in productive-aged women. About 60-70 % of women with PCOS are obese or overweight, and obesity is associated with insulin resistance. Since many women with PCOS seem to have insulin resistance, compensatory hyperinsulinemia is thought to contribute to hyperandrogenism by direct stimulation of ovarian production of androgens and by inhibition of liver synthesis of SHGB. It is important to ameliorate insulin resistance in PCOS patients.The aims of the present study is to examine whether TRF is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese PCOS patients.

Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome (PCOS)

Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome(PCOS): A Randomized Controlled Trial

Insulin resistance will be assessed by HOMA-IR

β cell function will be assessed by HOMA-β

liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan

Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).

Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde.

Changes in time to return to normal menstrual cycle

The First Affiliated Hospital of Xiamen University

Skin and Connective Tissue Diseases

Diabetes Mellitus

Prediabetic State

Breast Neoplasms

Glucose Intolerance

Breast Diseases

Skin Diseases

Metabolic Diseases

Glucose Metabolism Disorders

daily eating period of 8 hours, before 8 PM

Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.

Time restricted feeding

Participants will have a daily eating period equal to or greater than 12 hours.

Control

Harsha Karanchi, MD

Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. There are 2 in-person study visits to have blood, urine and vital signs collected and 8 remote or phone visits with a psychologist or dietician to assist with the eating schedule. The study will take last 3 1/2 months.

Postmenopausal women (no menstrual periods in the preceding 12 or more months) with pre-diabetes (A1C 5.7-6.4% and/or fasting glucose 100-125 mg/dL).

Time Restricted Eating on Cancer Risk

The Effects of Time Restricted Feeding on AGE-RAGE Signaling in Women at High Risk for Breast Cancer

Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.

Estimated mean levels within the intervention and the control groups of the study. Effect size will estimated via 95% confidence intervals within and between groups. .The intervention and control groups of AGE and sRAGE levels will be used to determined AGE by sRAGE ratio

Proportion of days that time period of eating was followed.

The Glasgow Prognostic Score (GPS) reflects systemic inflammatory process. Difference within groups and between groups of the cumulative inflammation-based cancer-prognostic marker. GPS is a three-tiered score \[0: normal C-reactive protein (CRP) and albumin; 1: one abnormal result; 2: increased CRP and low albumin\]. Higher score means worse outcome.

Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated by the 95% confidence intervals within and between groups.

Number of participants in the intervention and control group that completed virtual visits with the psychologist.

Change in sleep pattern between intervention and control groups as assessed using American Academy of Sleep Medicine 2 week sleep diaries.

Peripheral blood mononuclear cells will be analyzed for RAGE expression and compared within and between intervention and control groups.

Mean glucose, standard deviation (SD) of mean glucose values, co-efficient of variation (CV %) of sensor glucose levels, glucose management indicator (GMI%) from CGM data. Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated by the 95% confidence intervals within and between groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome (PCOS)	NCT03792282	Polycystic Ovar... Overweight and ...	Time Restricted... Usual care	18 Years - 50 Years	The First Affiliated Hospital of Xiamen University
Time Restricted Eating on Cancer Risk	NCT05038137	Pre-diabetes Breast Cancer Time Restricted...	Time restricted... Control	40 Years - 67 Years	Medical University of South Carolina
Time Restricted Eating on Cancer Risk	NCT05038137	Pre-diabetes Breast Cancer Time Restricted...	Time restricted... Control	40 Years - 67 Years	Medical University of South Carolina

Spots Global Cancer Trial Database for time restricted feeding