Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)

NCT02427529 | Completed Phase 1

• 1 other identifier: 053111
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects are female patients, randomized to HCG group or placebo group, during a prospective trial, in order to determine the significance, if any, of HCG on maintaining muscle mass during a very low calorie diet in order to demonstrate the potential significance of HCG administration on preserving lean body mass while losing weight.

Conditions

HCG

Keywords

hcg

Outcome Measures

Primary Outcomes (1)

• Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet.

  Comparison of weight loss between the experimental and control group

  30 days

Secondary Outcomes (1)

• Muscle loss comparison between HCG and placebo group during a very low calorie diet.

  30 days

Other Outcomes (1)

• Fat loss comparison between HCG and placebo groups during a very low calorie diet.

  30 days

Study Arms (2)

HCG Group

EXPERIMENTAL

This group received daily subcutaneous injections of Human Chorionic Gonadotropin while eating a very low calorie diet of 500 calories per day.

Drug: Human Chorionic Gonadotropin; Other: Low calorie diet

Saline/Placebo

PLACEBO COMPARATOR

This group received daily subcutaneous injections of saline while eating a very low calorie diet of 500 calories per day.

Drug: Placebo; Other: Low calorie diet

Interventions

Human Chorionic Gonadotropin DRUG

The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing.

Also known as: Pregnyl, Novarel

HCG Group

Placebo DRUG

Saline/Placebo

Low calorie diet OTHER

HCG Group; Saline/Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) greater than 30,
• Female,
• good health

You may not qualify if:

• complex medical history,
• thyroid disease,
• BMI less than 30,
• psychological instability or history of eating disorder

Sponsors & Collaborators

• Dr. Emma's Corporation: lead

Study Sites (1)

Dr. Emma's Corporation

Colts Neck, New Jersey, 07722, United States

Location

MeSH Terms

Conditions

Hypertrichosis congenital generalized X-linked

Interventions

Chorionic Gonadotropin; Caloric Restriction

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: April 28, 2015
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

US (1)