Research Using Health One

"MODEL" STUDY
Steven R. Smith, M.D. - “MODEL” Study: -combined study with Amylin/Lily using HEALTH ONE for weight loss and Amylin pharmaceutical agent for weight maintenance. 130 Type 2 diabetic subjects.
To begin - October 2006.

"TAKE TIME" STUDY
Steven R. Smith, M.D. - “TAKE TIME” Study: - 10-15% weight loss (using HEALTH ONE) in Type 2 diabetics and function of mitochondrial bio-markers.
To begin - November 2006

BOSS STUDY (now termed the HIP STUDY)
A study similar to the one described immediately below will be undertaken (late 2005) at the University of Buffalo, Center for Preventive Medicine. This study is underwritten by Blue Cross and Blue Shield of New York. For information go to link: www.sphhp.buffalo.edu/spm/research/index_curr.php. On this page go to the “Prevention and Disease Link” and then to the “HIP Evaluation of Treatments of Sever Obesity” link.

LOSS STUDY
The State of Louisiana, through the State Office of Group Benefits, is testing a variety of treatment protocols for weight management as to their efficacy to lower body weight, improve health parameters, and serve as a cost-saving approach, both for the individual and for the third party payer. This study is using HEALTH ONE plus "intensive counseling" as one of the "treatment arms." It is headed up by Dr. Donna Ryan, PBRC. For more information use the following web link: www.clinicaltrials.gov/ct/show/NCT00115063?order=26
This study started in July, 2005.

PILOT STUDY
Effectiveness of Diet Chain in Maintenenance of Weight Loss: A.Roberts, D, Williamson, F. Greenway, et.al.; PBRC patients will lose 15% of body weight using a low-calorie meal replacement of 800 calories per day (HEALTH ONE). A newly designed Diet Chain will then be tested for capacity to help patients maintain lowered body weight.
In progress.

"IS WEIGHT GAIN INEVITABLE WITH THIAZOLIDINEDIONES?"
Is Weight Gain Inevitable With Thiazolidinediones? Experience With Very Low Calorie Diets: Byron Richard, Sunil Asnani, Cyrus Desouza, Vivian Fonseca; Tulane University, New Orleans, LA: Curr. Med. Res. Opin. Vol 19 (7):609-613, 2003 Patients treated with TZD for type 2 diabetes usually gain weight. 8 type 2 diabetic patients on a variety of medications (including TZD’s) all reported weight gain (above their underlying obesity). These patients were given a low-calorie meal replacement of 800 calories per day (HEALTH ONE) and a mean weight loss of 26 pounds was attained during a 12 week period. Most discontinued or reduced their use of medications (including insulin) and gained glycemic control.

CALERIE STUDY
CALERIE STUDY (PI – Eric Ravussin): This study is sponsored by the National Institute of Aging and is designed to examine whether calorie restriction will increase lifespan in humans as it does in worms and rodents. This study is divided into 4 groups of 15 subjects with an initial BMI of 25-30 kg/m2: a control group, a group in which calories are restricted by 25%, a group in which calories are restricted by 12.5% and energy expenditure is increased by 12.5%, and a group in which weight is reduced by 15% using Health-1 and maintained with calorie restriction. The 6-month pilot study has been completed and the manuscript has been submitted for publication. The control group lost 1% of body weight (NS), the calorie restriction group lost 10% of body weight, the calorie restriction/exercise group lost 10% of body weight and the Health-1 group lost 13.5% of their body weight at the end of the study. The two calorie restriction groups still had a decreasing weight at the end of the study, but the HEALTH ONE and control groups were maintaining their weight. All three weight loss groups (including HEALTH ONE) decreased resting metabolic rate 6% below predicted and the core body temperature dropped compared to the control group. This is consistent with a reduction of oxidative stress, and is similar to what is seen in rodents with calorie restriction.
(Note -1st publication-JAMA, April 5, 2006-Vol. 295, No. 15; pp. 1539-1548).

METABOLIC EFFECTS OF CALORIC RESTRICTION
METABOLIC EFFECTS OF CALORIC RESTRICTION; F.Greenway, M.D., E, Ravussin, Ph.D.,et. al,; PBRC. This study will examine, among other things, the effect of weight and caloric control (using an LCD - HEALTH ONE) followed by a structured lifestyle counseling program on various health risks with particular focus on bio-markers of aging. The subjects will be in BMI range of 27-30 and part of a randomized trial looking at the preventive aspects of weight loss. It is funded by the NIH. Energy Restriction and Aging: J. Smith, L. Heilbronn, and E. Ravussin; Pennington Biomedical Research Center, Baton Rouge, LA; Current Opinion In Clinical Nutrition and Metabolic Care, Vol. 7; pp. 615-622, 2004.

PHARMACEUTICAL COST SAVINGS OF TREATING OBESITY WITH WEIGHT LOSS MEDICATIONS
PHARMACEUTICAL COST SAVINGS OF TREATING OBESITY WITH WEIGHT LOSS MEDICATIONS; F. Greenway, D. Ryan, G. Bray, et.al.; PBRC ; Obesity Research, Vol. 7, No. 6, pp. 523-531, 1999 Used a variety of anorectic/thermogenic weight loss medications (along with the HEALTH ONE Supplement) to attain a 20 pound weight loss with Type II Diabetics. Concluded that considerable cost savings were attained with reduction of medications used to control blood sugar. Also, attributed the health status improvement and cost savings to weight loss and not to any specific medication regimen employed.

OBESITY MEDICATIONS AND THE TREATMENT OF TYPE 2 DIABETES
OBESITY MEDICATIONS AND THE TREATMENT OF TYPE 2 DIABETES; F. Greenway, M.D.; PBRC; Diabetes Technology & Therapeutics, Vol. 1, No. 3 pp 277-287, 1999. Major review of medications used in the treatment of obesity and obesity related Type 2 Diabetes. Concludes that weight loss formulas of 800 cal/d are far more efficacious for initial weight loss and metabolic control; medications are best utilized in maintaining weight loss.

MOTIVATION AND WEIGHT MANAGEMENT: A CORRELATIONAL STUDY
MOTIVATION AND WEIGHT MANAGEMENT: A CORRELATIONAL STUDY; D. Drab, Ph.D., F. Greenway, M.D., et. al.; PBRC; Psychol. Assess., Jun; 13 (2): 189-198.

BODY FAT DISTRIBUTION AND CARDIOVASCULAR RISK FACTORS IN OBESITY
BODY FAT DISTRIBUTION AND CARDIOVASCULAR RISK FACTORS IN OBESITY AND NIDDM; R. Henry, M.D.; UC San Diego VA-Medical Center.
Unpublished Results*

METABOLIC EFFECT OF WEIGHT LOSS ON GLUCOSE METABOLISM AND INSULIN ACTION IN SKELETAL MUSCLE AND ADIPOSE TISSUE OF OBESE TYPE-2 DIABETICS AND NON-DIABETICS
METABOLIC EFFECT OF WEIGHT LOSS ON GLUCOSE METABOLISM AND INSULIN ACTION IN SKELETAL MUSCLE AND ADIPOSE TISSUE OF OBESE TYPE-2 DIABETICS AND NON-DIABETICS; R. Henry, M.D.& S. Medallier, M.D.; UC San Diego VA-Medical Center.
Unpublished Results*

SPECIFIC AIMS: To determine in vivo and in vitro metabolic effects of weight loss on glucose metabolism and insulin action in skeletal muscle and adipose tissue in obese non-diabetic and type-2 diabetic subjects

*Much of the results from the above 2 studies are discussed in: NUTRITIONAL MANAGEMENT OF OBESITY AND DIABETES; K. Griver, R.D. and Robert Henry, M.D., Nutrition Research,Vol. 14, No. 3, pp.465-483, 1994.