Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Weight Loss

Obesity

Body Weight

Endometrial Neoplasms

Body Weight Changes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants will take part in a Protein-Sparing Modified Fast (PSMF) Intervention for weight loss. Participants will undergo a dietary intervention high in protein for 6 weeks or until they have loss 15% of their body weight. This intervention will be followed by weight maintenance in which participants reintroduce non-starchy vegetables to their diet. At this time participants will also receive informational material and dietary education which teaches participants how to read nutrition labels and calculate carbohydrate loads in foods. Participants are given the Obesity and Weight-Loss Quality of Life Questionnaire to survey the impact of the intervention

Follow the Protein-Sparing Modified Fast (PSMF) intervention. This diet has participants consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight.

Dietary Intervention

Receive carbohydrate reintroduction handout

Informational Material

Receive education on nutrition label reading for carbohydrates

Dietary Education

weight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the high protein PSMF diet. During weight maintenance, consumption of non-starchy vegetables is unlimited

Weight Maintenance

Participants will take a tailored quality of life questionnaire. These scores will be averaged and a group mean reported. Higher scores indicate greater quality of life.

Average score of Obesity and Weight-Loss Quality of Life Questionnaire

Kimberly Resnick

This pilot clinical trial studies protein-sparing modified fast (PSMF) intervention for weight loss in obese endometrial cancer survivors. The PSMF is a diet that is very low in carbohydrates and calories, designed to induce fast, safe weight loss. The diet consists of only lean meats (beef, pork, poultry, and seafood) in amounts adequate to meet protein requirements based on the individual's body weight. The PSMF may help endometrial cancer survivors achieve significant weight loss, reduce the risk of chronic disease, and improve quality of life.

PRIMARY OBJECTIVES:

I. Investigate whether the PSMF leads to significant weight loss in obese endometrial cancer survivors (ECS).

II. To assess whether the approach is feasible, whether participants will remain in the study for the duration of the intervention while adhering to the various components of the protocol. To assess feasibility, examine the following variables: drop-out rates; rates of adherence to diet and supplemental protocol; and rates of common side-effects.

III. Assess whether the PSMF improves biomarkers of disease risk in this population. To assess whether this objective has been met, assess the following variables: blood lipids (total cholesterol, low density lipid \[LDL\] cholesterol, high density lipid \[HDL\] cholesterol, and triglycerides); glucose; and markers of inflammation (C-reactive protein, interleukin-6, tumor necrosis factor \[TNF\]-alpha, and leptin).

IV. Assess whether the PSMF leads to improvement in quality of life related to weight loss.

OUTLINE:

PSMF: Participants are instructed by a registered dietitian (RD) to consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight. The protein recommendation will be communicated to participants in terms of grams per day. Participants are encouraged to adhere as closely as possible to the protein recommendation. Based on the protein recommendation, participants are advised to consume a given amount (in ounces) of beef, pork, poultry and seafood daily, assuming that each ounce of these products contains seven grams of protein. Participants are provided with a digital kitchen scale to weigh protein-containing foods and are permitted up to 2 servings of non-starchy vegetables per day. Participants remain on the PSMF until they have successfully reduced their initial body weight by 15% or up to 6 months. Participants are also provided with supplements to consume daily.

WEIGHT MAINTENANCE DIET: After successful weight loss of at least 15% of initial body weight, participants are instructed by a RD to consume a weight maintenance diet or they may remain on the PSMF. The weight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the PSMF and consumption of non-starchy vegetables is unlimited. Participants receive handouts that list common foods and the number of carbohydrates in each serving and educated on nutrition label reading for carbohydrates, with emphasis on serving size and total number of carbohydrates per serving.

After completion of study, participants are followed up at 2 and 4 weeks and then at 2, 3, 4, 5, and 6 months.

Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors

A Pilot Study of a Protein-Sparing Modified Fast for Weight Loss in Obese Endometrial Cancer Survivors

Mean weight loss will be presented as mean total weight loss in kilograms from baseline

Mean Weight loss will be presented as mean total weight loss in kilograms from baseline.

Average differences in total cholesterol between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05.

Average differences in C-reactive protein between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05.

Differences in glucose levels between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05.

Presented as the difference in the number of participants who completed the study from the number of participants enrolled at baseline. This is reported as one of the markers of feasibility.

Assessed using the presence of urinary ketones beginning on day four of the intervention. Adherence rates will be presented as the percentage of positive urinary ketone tests for the duration of the intervention.

Adverse events will be recorded by participants on a daily basis. Number of participants with related adverse events will be reported as one of the measures of feasibility

The difference between mean quality of life scores at the two time points will be assessed using a one-sided anova test with statistical significance set at p \< 0.05.

Average differences in interleukin 6 between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05.

Average differences in tumor necrosis factor - alpha between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05.

Average differences of leptin between time points will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05.

Average differences between time points for LDL-cholesterol will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05.

Average differences between time points for HDL-cholesterol will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05.

Average differences between time points for triglycerides will be assessed using a one-sided anova test with statistical significance defined as having a p-value \< 0.05.

National Cancer Institute (NCI)

Case Comprehensive Cancer Center

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

simplified dietary education arm in subtotal gastrectomy group.

intensive dietary education arm in subtotal gastrectomy group

simplified dietary education arm in total gastrectomy group.

intensive dietary education arm in total gastrectomy group

Dietary education provided to gastrectomy patients by dietitian.

Dietary education(nutritional counselling)

Jae-Moon Bae, MD, Ph.D

Aron Lee, RD

Aron Lee

Bo Ram Park, Ph.D.

Radical gastrectomy has been known as the most effective treatment of curable gastric cancer.However, there is a high risk of malnutrition and weight loss after a gastrectomy which may be attributed to inadequate oral consumption, malabsorption and loss of the reservoir function of the stomach.Weight loss has been regarded as an independent risk factor for postoperative mortality and morbidity and It is also closely associated with a quality of life after surgery. No specific surgical technique has been proved to be effective in reducing postoperative weight loss and it seems like that dietary education and consultation is the best way to minimize weight loss in gastrectomy patients in clinical setting. In this regard, the investigators performed a retrospective pilot study to identify the effect of routinely performed (simplified) dietary education on nutritional status after gastrectomy, but it revealed that the effect of simplified dietary education on weight loss was not clear and the result implies that more intensive dietary education may be necessary after gastrectomy. The aim of this randomized controlled trial (RCT) is to elucidate the effect of intensive dietary education on nutritional status after gastrectomy in comparison with simplified dietary education.

Subject 1: subtotal gastrectomy group

subject 2: total gastrectomy group

Objectives:

Primary objective: to evaluate Weight loss difference of simplified dietary education(SE) versus intensive dietary education(IE) for patients after undergoing a gastrectomy

Primary endpoint: Superiority of weight loss difference (%) of IE group between post op 1mo and 12mo

Secondary objectives:

weight loss(%) of each subgroup, nutritional parameters (PG-SGA), Calrorie intake \& dietary habits, albumin, hemoglobin, iron panel (TIBC, ferritin), Absolute lymphocyte count(ALC), vit B12, homocysteine, quality of life(QOL) change

1. Nutritional parameters (PG-SGA)
2. the amount of calorie intake (Kcal, protein) \& dietary habits
3. Albumin (g/dL)
4. Hemoglobin (g/dL)
5. Iron panel \[TIBC (μg/dL), Ferritin (ng/mL)\]
6. Absolute lymphocyte count (ALC) (10\^3/μL)
7. Vitamin B12 (pg/mL)
8. Homocysteine (μmol/L)
9. Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)

Simplified dietary education(SE) versus Intensive dietary education(IE)

1. Subtotal gastrectomy group (n=258)
2. Total gastrectomy group (n=100)

The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)

A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy

comparison of weight change between the two groups after surgery

measured by Patient-Generated Subjective Global Assessment (PG-SGA; rating A,B,C)

calculating kcal \& protein intake by 24hrs dietary recall (questionnaire)

number of meals, eating speed (questionnaire)

European quality of life questionnaire (EQ-5D); the descriptive system which comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems (labelled 1-3).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors	NCT02135562	Endometrial Can... Obesity	Dietary Interve... Informational M... Dietary Educati... Weight Maintena... Average score o...	18 Years - 70 Years	Case Comprehensive Cancer Center
The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)	NCT04798820	Gastric Cancer Gastrectomy	Dietary educati...	20 Years - 75 Years	Samsung Medical Center

Spots Global Cancer Trial Database for dietary education