- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03082781
Dietary Choice in Active Older Adult Women
A Comparative Assessment of Weight Loss and Anti-lipid Effects of Negative Calorie Diet and Low-calorie Diet in Overweight/Obese Middle-aged and Older Women Under Exercise Condition
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background: Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method.
Objectives: The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult women with abnormal weight gain.
Material and Methods: Participants included sedentary women (age 45-75 years) with overweight or obesity (n=111). They were randomly divided into two groups including negative calorie diet with exercise, and low-calorie diet with exercise. Of all 111 participants, 90 persons completed the treatment. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study.
Exclusion Criteria:
History of CVD and other disorders such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals. Subjects with abnormality in thyroid or Electrocardiograph, any history of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Study group I
Study group I (57 participants) received the NCD with exercise (NCDsport).This groups had 5% caloric restriction from their maintenance energy requirements and 10% increase in energy expenditure through structured regular exercise.
|
Negative Calorie Diet supplemented with exercise
Andre navne:
|
Eksperimentel: Study group II
Study group II (54 participants) received the low-calorie diet with exercise (LCDsport).
This groups had 5% caloric restriction from their maintenance energy requirements and 10% increase in energy expenditure through structured regular exercise.
|
Low-Calorie diet with exercise
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Vægt
Tidsramme: Baseline
|
vurderet i kg
|
Baseline
|
Total kolesterol (Total-C)
Tidsramme: Baseline
|
vurderet i mg/dl
|
Baseline
|
High-density lipoprotein-kolesterol (HDL-C)
Tidsramme: Baseline
|
vurderet i mg/dl
|
Baseline
|
Low-density lipoprotein-kolesterol (LDL-C)
Tidsramme: Baseline
|
vurderet i mg/dl
|
Baseline
|
Triglycerider (TG)
Tidsramme: Baseline
|
vurderet i mg/dl
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Vægt
Tidsramme: 3-måneder
|
vurderet i kg
|
3-måneder
|
Total kolesterol (Total-C)
Tidsramme: 3-måneder
|
vurderet i mg/dl
|
3-måneder
|
High-density lipoprotein-kolesterol (HDL-C)
Tidsramme: 3-måneder
|
vurderet i mg/dl
|
3-måneder
|
Low-density lipoprotein-kolesterol (LDL-C)
Tidsramme: 3-måneder
|
vurderet i mg/dl
|
3-måneder
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- No Grant 5
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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