ObesityTRENDNCT02837211
The TREND Study: Tapered Reduction in Energy Intake as a Novel Approach to Dieting
A study testing Tapered Low Calorie Diet and Traditional Low-Calorie Diet in people with Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Obesity
- What is being tested?
- Tapered Low Calorie Diet and Traditional Low-Calorie Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 11 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
Read the detailed description
Diets are the mainstay of many obesity treatment programs, yet they fail for a variety of reasons. Patients find it difficult to comply with caloric restriction during active weight loss, and to adhere to long-term changes that promote weight loss maintenance. Underlying these difficulties are a number of physiologic changes enacted by the body in response to energy restriction. These changes promote increased hunger, decreased satiety and slowed metabolic rate, making diet compliance and sustained weight loss very difficult. From the body's perspective, a rapid and substantial drop in caloric intake may represent a metabolic emergency, and it responds accordingly, in an attempt to maintain body weight.
Weight loss results only from achieving and maintaining a large energy deficit, but it is not known whether the initiation phase of diets would be more likely to promote success if it were done gradually, in the form of a caloric taper. We hypothesize that, by slowly introducing a prescribed caloric restriction over a period of 1-2 months (rather than using an immediate drop in calories), the body's homeostatic response to energy restriction might be blunted or circumvented, resulting in lower levels of hunger, improved satiety, and better preservation of metabolic rate during diet initiation - all factors that would promote adherence and successful weight loss.
To test this hypothesis, the investigators will conduct a pilot randomized feeding trial comparing two types of low-calorie diets with similar macronutrient composition. Although both diets will ultimately rely on similar caloric deficits to produce weight loss, they will differ at the point of diet initiation. The following will be compared: (1) a traditional diet, where the entire energy deficit is initiated immediately; and (2) a "caloric taper" diet, during which participants will be gradually reduced from baseline levels of energy consumption to the lower calorie level required for weight loss, over a 6-week period.
After a 2-week run-in to establish equilibrium weight among 40 eligible persons, 30 obese adults will be randomized to the 2 study arms and follow them for 52 weeks. We will compare the two groups with respect to the following outcomes, measured in terms of change from baseline (week 0) levels:
- Circulating levels of the orexogenic hormone, Ghrelin, at weeks 1, 6, 12, 24, and 52;
- Circulating levels of the "satiety" hormones, Leptin and Glucagon-like Peptide (GLP-1) at weeks 1, 6, 12, 24, and 52;
- Body composition, as assessed with dual energy x-ray absorptiometry, at 24 and 52 weeks;
- Resting metabolic rate as assessed by indirect calorimetry at 24 and 52 weeks;
- Change in body weight (kg) and body mass index (kg/m2) at weeks 6,12, 24 and 52;
- Self-reported hunger (using VAS) and compliance with program at weeks 1, 6, 12, 24 and 52.
- Change in weight-related quality of life, using the IWQOL-LITE at weeks 12, 24, and 52.
Hypothesis: patients in the "taper" arm will experience less activation of body regulatory systems designed to oppose weight loss, with similar weight loss by 24 weeks and greater weight loss maintenance by 52 weeks, compared to "traditional low-calorie diet" arm patients.
- Conditions
- Obesity
- Being tested
- Tapered Low Calorie Diet, Traditional Low-Calorie Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapered Low Calorie DietBehavioural
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.
Traditional Low-Calorie DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tapered Diet | Experimental | Not described Receives: Behavioral: Tapered Low Calorie Diet |
| Traditional Low Calorie Diet | Active comparator | Not described Receives: Behavioral: Traditional Low-Calorie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ghrelin
Orexogenic hormone
Measured: change from baseline at weeks 1, 6, 12, 24, 52
Leptin
Satiety hormone
Measured: change from baseline at weeks 1, 6, 12, 24, 52
Secondary outcomes (6)
Glucagon-like peptide-1 (GLP1)
Satiety hormone
Measured: change from baseline at weeks 1, 6, 12, 24, 52
Body Composition (percent body fat, percent lean mass)
Assessed with DEXA Scan
Measured: change from baseline at week 24 and 52
Resting Metabolic Rate (RMR)
Assessed with indirect calorimetry
Measured: change from baseline at weeks 12, 24, 52
Weight (kg)
Measured: Change from baseline at weeks 6, 12, 24 and 52
Hunger
Visual-analogue scale, self report
Measured: weeks 1, 6, 12, 24, 52
Weight-related quality of life (IWQOL-Lite)
Validated survey measure
Measured: Change from baseline at weeks 12, 24, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startAug 2016
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina H Lewis, MD MPH SM, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837211
- Sponsor's protocol ID
- IRB00037795
- Acronym
- TREND
- Status last verified
- Aug 2018
- First submitted
- 15 Jul 2016
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TREND Study: Tapered Reduction in Energy Intake as a Novel Approach to Dieting
- ClinicalTrials.gov ID
- NCT02837211
- Acronym / sponsor ID
- TREND / IRB00037795
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diets are the mainstay of many obesity treatment programs, yet they fail for a variety of reasons. Patients find it difficult to comply with caloric restriction during active weight loss, and to adhere to long-term changes that promote weight loss maintenance. Underlying these difficulties are a number of physiologic changes enacted by the body in response to energy restriction. These changes promote increased hunger, decreased satiety and slowed metabolic rate, making diet compliance and sustained weight loss very difficult. From the body's perspective, a rapid and substantial drop in caloric intake may represent a metabolic emergency, and it responds accordingly, in an attempt to maintain body weight.
Weight loss results only from achieving and maintaining a large energy deficit, but it is not known whether the initiation phase of diets would be more likely to promote success if it were done gradually, in the form of a caloric taper. We hypothesize that, by slowly introducing a prescribed caloric restriction over a period of 1-2 months (rather than using an immediate drop in calories), the body's homeostatic response to energy restriction might be blunted or circumvented, resulting in lower levels of hunger, improved satiety, and better preservation of metabolic rate during diet initiation - all factors that would promote adherence and successful weight loss.
To test this hypothesis, the investigators will conduct a pilot randomized feeding trial comparing two types of low-calorie diets with similar macronutrient composition. Although both diets will ultimately rely on similar caloric deficits to produce weight loss, they will differ at the point of diet initiation. The following will be compared: (1) a traditional diet, where the entire energy deficit is initiated immediately; and (2) a "caloric taper" diet, during which participants will be gradually reduced from baseline levels of energy consumption to the lower calorie level required for weight loss, over a 6-week period.
After a 2-week run-in to establish equilibrium weight among 40 eligible persons, 30 obese adults will be randomized to the 2 study arms and follow them for 52 weeks. We will compare the two groups with respect to the following outcomes, measured in terms of change from baseline (week 0) levels:
- Circulating levels of the orexogenic hormone, Ghrelin, at weeks 1, 6, 12, 24, and 52;
- Circulating levels of the "satiety" hormones, Leptin and Glucagon-like Peptide (GLP-1) at weeks 1, 6, 12, 24, and 52;
- Body composition, as assessed with dual energy x-ray absorptiometry, at 24 and 52 weeks;
- Resting metabolic rate as assessed by indirect calorimetry at 24 and 52 weeks;
- Change in body weight (kg) and body mass index (kg/m2) at weeks 6,12, 24 and 52;
- Self-reported hunger (using VAS) and compliance with program at weeks 1, 6, 12, 24 and 52.
- Change in weight-related quality of life, using the IWQOL-LITE at weeks 12, 24, and 52.
Hypothesis: patients in the "taper" arm will experience less activation of body regulatory systems designed to oppose weight loss, with similar weight loss by 24 weeks and greater weight loss maintenance by 52 weeks, compared to "traditional low-calorie diet" arm patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tapered Diet | Experimental | Behavioral: Tapered Low Calorie Diet |
| Traditional Low Calorie Diet | Active comparator | Behavioral: Traditional Low-Calorie Diet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapered Low Calorie DietAll 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. | Behavioural | Tapered Diet |
| Traditional Low-Calorie DietAll 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. | Behavioural | Traditional Low Calorie Diet |
Primary outcome
Ghrelin
Time frame: change from baseline at weeks 1, 6, 12, 24, 52
Orexogenic hormone
Leptin
Time frame: change from baseline at weeks 1, 6, 12, 24, 52
Satiety hormone
6 secondary outcomes
Glucagon-like peptide-1 (GLP1)
Time frame: change from baseline at weeks 1, 6, 12, 24, 52
Body Composition (percent body fat, percent lean mass)
Time frame: change from baseline at week 24 and 52
Resting Metabolic Rate (RMR)
Time frame: change from baseline at weeks 12, 24, 52
Weight (kg)
Time frame: Change from baseline at weeks 6, 12, 24 and 52
Hunger
Time frame: weeks 1, 6, 12, 24, 52
Weight-related quality of life (IWQOL-Lite)
Time frame: Change from baseline at weeks 12, 24, and 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina H Lewis, MD MPH SM principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tapered Low Calorie Diet and Traditional Low-Calorie Diet in people with Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ghrelin (time frame: change from baseline at weeks 1, 6, 12, 24, 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018; AzTrials last refreshed its copy on 5 Nov 2026.