Metabolic Syndrome and Functional Food
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      High blood sugar and adiposity are part of Metabolic syndrome (about 24% of adults harbor
      it). The main approach, weight reduction, is often unattainable. Aloe Vera (barbadensis) (AV)
      and cnidoscolus chayamansa (McVaugh)(CC) are two vegetables that seem to have an effect on
      blood glucose and body weight.

      The study aims to determine if the intake of aloe gel and/or Chaya infusion can reduce high
      blood sugar in adult women with pre-diabetes (Metabolic Syndrome).

      Methods: A Factorial assay, double blind, cross-over-controlled with random assignment, to
      four treatments: AV and CC, AV and Placebo 1, Placebo 2 and CC, and Placebo 1 and Placebo 2,
      at the outpatient clinic of the university Hospital and a community clinic.

      Two treatment periods of 4 weeks intermediated by one week for wash-out.
    


Intervention name(s): P1&P2; P1&CC; AG&P2; AG&CC; TA (concentrated 5:1 aloe vera gel); P3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): First period (4 weeks) intake food product P1&P2 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet
Second period, cross over from AG&CC group, 4 weeks intake food product P1&P2 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet; First period (4 weeks) intake food product P1&CC (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
Second period, cross over from AG&P2 group, 4 weeks intake food product P1&CC (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet.; First period (4 weeks) intake food product AG&P2 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
Second period, cross over from P1&CC group, 4 weeks intake food product AG&P2 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet; First period (4 weeks) intake food product AG&CC (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet
Second period, cross over from P1&P2 group, 4 weeks intake food product AG&CC (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet; First period (4 weeks) intake food product TA (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
Second period, cross over from P3 group, 4 weeks intake food product TA (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet.; First period (4 weeks) intake food product P3 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet.
Second period, cross over from TA group, 4 weeks intake food product P3 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet.
Other intervention name(s): Placebo 1 and Placebo 2; Placebo 1 and Cnidoscolus Chayamansa infusion; Aloe Vera Gel and Placebo 2; Aloe Vera gel and Cnidoscolus Chayamansa infusion; Sabila & Chaya infusion; Total Aloe concentrated 5:1 aloe vera gel by total process; Placebo 3
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyperglycemia; overweight; functional food; aloe vera; cnidoscolus chayamansa