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Soy Peptide, Conjugated Linoleic Acid, Overweight or Obese, Body Composition

F

Fangfang Zeng

Status

Unknown

Conditions

Overweight or Obesity

Treatments

Dietary Supplement: Experimental group
Dietary Supplement: Control group

Study type

Interventional

Funder types

Other

Identifiers

NCT04728399
JNUKY-2020-002

Details and patient eligibility

About

Soybean peptides are a mixture of active peptides obtained from the hydrolysis of soybean protein, which have biological activities such as antioxidant, blood pressure lowering, anti-fatigue and lipid lowering, etc. They can regulate food intake, increase satiety, and reduce fat body ratio by reducing cholesterol and triglyceride content and stimulating CCK secretion.Conjugated linoleic acid (CLA) is a set of linoleic acid with conjugated unsaturated double bond, the location and structure of the isomers have been approved by the ministry of health in China as a new resource food , widely used in areas such as health care products, functional foods and food additives, animal experiments showed that it has reduce tumor, atherosclerosis, obesity risk.Therefore, in this study, the effect of conjugated linoleic acid combined with soybean peptide on overweight and obese people was investigated in a randomized controlled manner.

Full description

Aim 1: To test the effects of combined supplementation of soybean peptide and conjugated linoleic acid on body fat, liver fat and muscle content of overweight and obese people;Aim 2: To test the effects of combined supplementation of soybean peptide and conjugated linoleic acid on blood lipid, blood glucose, fat or inflammatory factors in overweight and obese people; Aim 3: Test the impact of the above interventions on safety indicators (safety indicators: liver and kidney function, self-reported adverse reactions or diseases). Aim 4: To provide scientific basis for the development of functional food for weight loss and muscle gain.The public health significance of this research is that find a new functional food for weight loss and muscle gain.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age - 18-65 years old;
  • Gender-not limited;
  • BMI-24-35 kg/m2;
  • Body fat rate-Male ≥25%, female ≥30% (body fat meter can be used for screening, DXA is used for diagnosis);
  • Waist circumference: male >90cm, Female>80cm (not required).

Exclusion criteria

  • Suffer from serious diseases such as heart, liver, kidney, brain, hematopoietic, immune, thyroid, malignant tumors;
  • Take drugs or supplements that have a known effect on body fat and muscle mass;
  • Those whose weight has changed more than 10% in the past 3 months;
  • Those who have cognitive or mental disorders and cannot conduct questionnaire surveys;
  • People who are physically disabled and cannot walk normally;
  • Those whose compliance with the pre-experiment period cannot meet the requirements;
  • Fail to sign the informed consent form, or other researchers think it is not suitable for participants

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups, including a placebo group

Experimental group
Experimental group
Description:
2g Soybean peptide, 3g CLA and ng protein.
Treatment:
Dietary Supplement: Experimental group
Control group
Placebo Comparator group
Description:
2g+N protein and 3g Soybean oil.
Treatment:
Dietary Supplement: Control group

Trial contacts and locations

1

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Central trial contact

Fangfang Zeng; Sixian Tab

Data sourced from clinicaltrials.gov

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