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ObesityNCT02399280

Effect of High Caloric Intake at Lunch Against Dinner on Weight Loss

A study testing Lunch as main meal(LM)+ Diet and Dinner as main meal(DM)+ Diet in people with Obesity and Overweight, run by Novindiet Clinic at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the present study is to evaluate the effect of consuming higher caloric intake at lunch in contrast to dinner on weight loss of obese and overweight female adults when they are in a multidisciplinary weight loss plan . Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight
What is being tested?
Lunch as main meal(LM)+ Diet and Dinner as main meal(DM)+ Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteIran
Study dates
Feb 2015to Aug 2015
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
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Must have Body mass index (BMI) between 27-35 kg/ m².
  • Must be able to have moderate exercise.
  • Must be interested to have weight loss.

Who cannot join

  • Participating in a research project involving weight loss or physical activity in the previous six months.
  • Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
  • Taking medication that could affect metabolism or change body weight.
  • Report heart problems, chest pain, and cancer within the last five years.
  • Smoking
  • Menopause
  • Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • NovinDiet Clinic

    Tehran, Tehran Province, 1913635136

Other trials in Iran

About this study

Official title: Effect of High Caloric Intake at Lunch Against Dinner on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program, a Randomized Clinical Trial

The purpose of the present study is to evaluate the effect of consuming higher caloric intake at lunch in contrast to dinner on weight loss of obese and overweight female adults when they are in a multidisciplinary weight loss plan .

Conditions
Obesity, Overweight
Being tested
Lunch as main meal(LM)+ Diet, Dinner as main meal(DM)+ Diet
Keywords
Meal pattern, weight loss, high caloric intake, Dinner, Lunch
Medical subject headings
Obesity, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lunch as main meal(LM)+ DietBehavioural

    Subjects are asked to have high caloric intake at lunch and low caloric intake at dinner, while they are on a multidisciplinary weight loss plan for 12 weeks.

  • Dinner as main meal(DM)+ DietBehavioural

    Subjects are asked to have high caloric intake at dinner and low caloric intake at lunch, while they are on a multidisciplinary weight loss plan for 12 weeks.

Study groups in NCT02399280
Study groupRoleWhat they receive
LunchExperimentalLunch as main meal(LM)+ Diet
Receives: Behavioral: Lunch as main meal(LM)+ Diet
DinnerExperimentalDinner as main meal(DM)+ Diet
Receives: Behavioral: Dinner as main meal(DM)+ Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. weight loss

    Measured: 12 weeks

Secondary outcomes (5)

  1. waist circumference

    Measured: 12 weeks

  2. Fasting plasma glucose level

    Measured: 12 weeks

  3. Lipid profiles

    Measured: 12 weeks

  4. Insulin resistance(HOMA)

    Measured: 12 weeks

  5. Body mass index

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionJun 2015
  4. Study completionAug 2015

Resources

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
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02399280
Sponsor's protocol ID
ND-106
Status last verified
Apr 2017
First submitted
22 Mar 2015
Last updated
5 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Madjd A, Taylor MA, Delavari A, Malekzadeh R, Macdonald IA, Farshchi HR. Beneficial effect of high energy intake at lunch rather than dinner on weight loss in healthy obese women in a weight-loss program: a randomized clinical trial. Am J Clin Nutr. 2016 Oct;104(4):982-989. doi: 10.3945/ajcn.116.134163. Epub 2016 Aug 31.

    PubMed 27581472

Questions about this trial

What is this clinical trial studying?

A study testing Lunch as main meal(LM)+ Diet and Dinner as main meal(DM)+ Diet in people with Obesity and Overweight, run by Novindiet Clinic at 1 site in Iran.

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 3 inclusion and 7 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 5 Apr 2017. 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 Iran. 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?

weight loss (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02399280, which also lists 1 linked publication.

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 5 Apr 2017.

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