The TREND Study: Tapered Reduction in Energy Intake as a Novel Approach to Dieting

NCT02837211 | Completed

• 1 other identifier: IRB00037795
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

TREND is a pilot randomized trial comparing two alternative methods of initiating a low-calorie weight loss diet. The study will compare the traditional diet initiation of abruptly dropping energy intake to 1000 kcal/day for women and 1200 kcal/day for men versus a 6 week tapering of energy intake from a baseline level. These two approaches will be compared with respect to their impact on energy regulatory systems of the body, weight loss and other measures, up to a year after diet initiation.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Ghrelin

  Orexogenic hormone

  change from baseline at weeks 1, 6, 12, 24, 52

• Leptin

  Satiety hormone

  change from baseline at weeks 1, 6, 12, 24, 52

Secondary Outcomes (6)

• Glucagon-like peptide-1 (GLP1)

  change from baseline at weeks 1, 6, 12, 24, 52

• Body Composition (percent body fat, percent lean mass)

  change from baseline at week 24 and 52

• Resting Metabolic Rate (RMR)

  change from baseline at weeks 12, 24, 52

• Weight (kg)

  Change from baseline at weeks 6, 12, 24 and 52

• Hunger

  weeks 1, 6, 12, 24, 52

Study Arms (2)

Tapered Diet

EXPERIMENTAL

Behavioral: Tapered Low Calorie Diet

Traditional Low Calorie Diet

ACTIVE COMPARATOR

Behavioral: Traditional Low-Calorie Diet

Interventions

Tapered Low Calorie Diet BEHAVIORAL

All participants will start with a 3 week run-in period during which they are fed a diet at 1.4 x their resting metabolic rate (kcal). Participants who are weight stable at the end of run in and are randomized to the Tapered Diet Arm will undergo the following 24 week feeding study intervention. The difference between a participant's run-in period energy intake and low-calorie "prescribed" energy intake (1000 kcal for women; 1200kcal for men) will be divided by six. At weekly intervals from weeks 1-6, daily caloric intake will be decreased by this fixed amount, reaching the final daily caloric goal (1000 kcals for women and 1200 kcals for men) by the end of the 6th week. Participants will present twice per week during weeks 1-6 to receive food that sums to that week's prescribed calorie level. From weeks 7-24, these participants will then follow a traditional low-calorie diet, still presenting for food pickups twice per week at a stable caloric level during this period.

Tapered Diet

Traditional Low-Calorie Diet BEHAVIORAL

All participants will start with a 3 week run-in period during which they are fed a diet at 1.4 x their resting metabolic rate (kcal). Participants who are weight stable at the end of run in and are randomized to the Traditional Diet Arm will undergo the following 24 week feeding study intervention. Immediately following run-in, these participants will start a low-calorie diet (1000 kcal per day for women; 1200kcal for men) Participants will present twice per week during weeks 1-24 to receive food that sums to that week's prescribed calorie level.

Traditional Low Calorie Diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Employee of Wake Forest Baptist Medical Center
• BMI 30-40 kg/m2
• Interested in weight loss
• \<90 min/wk of exercise at baseline
• Receives medical care through Wake Forest and has WakeOne account

You may not qualify if:

• Already participating in another diet or weight loss program or research study
• History of bariatric surgery
• History of eating disorder
• History of cancer (other than non-melanomatous skin cancer)
• History of thyroid disease
• History of severe mental illness
• Diagnosis of diabetes
• Currently pregnant, breastfeeding or planning pregnancy
• Peri or post-menopausal
• Food allergies or sensitivities
• Vegetarian
• Night Shift worker
• Planning prolonged travel in next 6-8 months or frequent out of town travel
• on any medication that could promote weight loss or weight gain

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristina H Lewis, MD MPH SM

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 19, 2016
• Study Start: August 1, 2016
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

US (1)